Trial Outcomes & Findings for A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus (NCT NCT04535544)
NCT ID: NCT04535544
Last Updated: 2026-07-22
Results Overview
Percentage of participants with hepatitis D virus (HDV) RNA greater than or equal to (\>=) 2 log10 international units per milliliter (IU/mL) decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT less than (\<) upper limit of normal (ULN) with ULN = 34 units per liter (U/L) for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Week 48
Results posted on
2026-07-22
Participant Flow
Adult participants co-infected with hepatitis B virus (HBV) and hepatitis D virus (HDV) were considered eligible for participation. Participants with compensated cirrhosis were allowed to be enrolled in Part 1 but excluded from Part 2 of the study.
The study consisted of 2 parts: 1 and 2. Part 2 was initiated when the protocol specified antiviral activity criteria was met in Part 1 and when all participants of Part 1 had completed at least Week 16 or discontinued earlier. Unique participants were randomized (4:1) to JNJ-73763989 + NA and Placebo + NA in Part 1 and 2.
Participant milestones
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Double-blind (Day 1 up to Week 52)
STARTED
|
17
|
5
|
24
|
6
|
|
Double-blind (Day 1 up to Week 52)
COMPLETED
|
15
|
5
|
20
|
6
|
|
Double-blind (Day 1 up to Week 52)
NOT COMPLETED
|
2
|
0
|
4
|
0
|
|
Open-label (Week 52 up to Week 148)
STARTED
|
5
|
4
|
14
|
5
|
|
Open-label (Week 52 up to Week 148)
COMPLETED
|
4
|
3
|
13
|
4
|
|
Open-label (Week 52 up to Week 148)
NOT COMPLETED
|
1
|
1
|
1
|
1
|
|
Follow-up (Week 12 up to Week 196)
STARTED
|
14
|
4
|
19
|
5
|
|
Follow-up (Week 12 up to Week 196)
COMPLETED
|
10
|
4
|
13
|
4
|
|
Follow-up (Week 12 up to Week 196)
NOT COMPLETED
|
4
|
0
|
6
|
1
|
Reasons for withdrawal
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Double-blind (Day 1 up to Week 52)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Double-blind (Day 1 up to Week 52)
Withdrawal by Subject
|
2
|
0
|
3
|
0
|
|
Open-label (Week 52 up to Week 148)
Withdrawal by Subject
|
1
|
1
|
1
|
1
|
|
Follow-up (Week 12 up to Week 196)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Follow-up (Week 12 up to Week 196)
Withdrawal by Subject
|
4
|
0
|
4
|
0
|
|
Follow-up (Week 12 up to Week 196)
Other
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
Baseline characteristics by cohort
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Region of Enrollment
France
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 10.44 • n=9 Participants
|
44.2 years
STANDARD_DEVIATION 11.88 • n=27 Participants
|
43.8 years
STANDARD_DEVIATION 9.49 • n=267 Participants
|
44.8 years
STANDARD_DEVIATION 11.96 • n=265 Participants
|
43 years
STANDARD_DEVIATION 10.11 • n=568 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
23 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
29 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
50 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
41 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
10 Participants
n=568 Participants
|
|
Region of Enrollment
New Zealand
|
4 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
|
Region of Enrollment
Russian Federation
|
3 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Region of Enrollment
Spain
|
3 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
|
Region of Enrollment
Sweden
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Region of Enrollment
Taiwan
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Region of Enrollment
Turkey
|
2 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
15 Participants
n=568 Participants
|
|
Region of Enrollment
United Kingdom
|
3 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Intent-to-Treat analysis set (ITT) included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure.
Percentage of participants with hepatitis D virus (HDV) RNA greater than or equal to (\>=) 2 log10 international units per milliliter (IU/mL) decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT less than (\<) upper limit of normal (ULN) with ULN = 34 units per liter (U/L) for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=12 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Double-blind:Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach)
|
33.3 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 48Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure.
Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=20 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT at Week 48 (Multiple Imputation Approach)
|
30.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: ITT set included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure.
Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA \< LLOQ at Week 48 was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=10 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=15 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA < Lower Limits of Quantification (LLOQ) at Week 48
|
40.0 Percentage of Participants
|
0 Percentage of Participants
|
73.3 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 48Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure.
Percentage of participants with normal ALT at Week 48 was reported. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=9 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=15 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Normal ALT at Week 48
|
44.4 Percentage of Participants
|
40.0 Percentage of Participants
|
53.3 Percentage of Participants
|
16.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 48Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to.
Percentage of participants with HBsAg seroclearance at Week 48 was reported. HBsAg seroclearance was defined as HBsAg negativity (quantitative HBsAg level \<LLOQ) based on the assay used.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 48
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 48Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure.
Percentage of participants with \>=2 kPa reduction from baseline in LSM assessed by VCTE (fibroscan) at Week 48 was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=6 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=12 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=4 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With >=2 Kilopascal (kPa) Reduction From Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) (FibroScan) at Week 48
|
50.0 Percentage of Participants
|
20.0 Percentage of Participants
|
25.0 Percentage of Participants
|
25.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=12 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT
Week 48
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT
Follow-up Week 24
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=20 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT
Week 48
|
30.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT
Follow-up Week 24
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48 and FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline in combination with normal ALT was reported. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=10 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline in Combination With Normal ALT
Week 48
|
40.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline in Combination With Normal ALT
FU Week 24
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48 and FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline in combination with normal ALT was reported. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=16 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline in Combination With Normal ALT
Week 48
|
40.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline in Combination With Normal ALT
FU Week 24
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48 and FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HDV RNA TND in combination with normal ALT was reported. Normal ALT is defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. TND was defined as no traces of HBV RNA were detected/found. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=10 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With HDV RNA TND in Combination With Normal ALT
Week 48
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HDV RNA TND in Combination With Normal ALT
FU Week 24
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48 and FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HDV RNA TND in combination with normal ALT was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=16 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With HDV RNA TND in Combination With Normal ALT
Week 48
|
6.7 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HDV RNA TND in Combination With Normal ALT
FU Week 24
|
31.3 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48 and FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND was reported. TND was defined as no traces of HBV RNA were detected/found. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=10 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND
Week 48
|
40.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND
FU Week 24
|
10.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48 and FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND was reported. TND was defined as no traces of HBV RNA were detected/found. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=16 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND
Week 48
|
66.7 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND
FU Week 24
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48 and FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (Overall number of participants analyzed) refers to number of participants evaluable for this outcome measure and 'n' (number analyzed) refers to number of participants evaluable at specified timepoints.
Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=10 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline
Week 48
|
40.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline
FU Week 24
|
10.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48 and FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=16 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline
Week 48
|
66.7 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline
FU Week 24
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HDV RNA TND was reported. TND was defined as no traces of HBV RNA were detected/found.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=10 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With HDV RNA TND
Week 48
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HDV RNA TND
FU Week 24
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HDV RNA TND was reported. TND was defined as no traces of HBV RNA were detected/found.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=16 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With HDV RNA TND
Week 48
|
6.7 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HDV RNA TND
FU Week 24
|
31.3 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure.
Percentage of participants with Normal ALT was reported. Normal ALT was defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=13 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=4 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With Normal ALT
|
44.4 Percentage of Participants
|
25.0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure.
Percentage of participants with Normal ALT was reported. Normal ALT was defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=13 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=4 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With Normal ALT
|
53.8 Percentage of Participants
|
25.0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Placebo + NA: From Day 1 up to Week 196; JNJ-3989 + NA: From Day 1 up to Week 192Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to.
Time to reach HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND was planned to be reported. It is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of HDV RNA \>= 2 log10 IU/mL decline or HDV RNA TND, whichever event is first (that is, minute \[the date of the first HDV RNA \>= 2 log10 IU/mL decline, date of the first time HDV RNA is TND\] - the date of first study intervention intake + 1). TND was defined as no traces of HBV RNA were detected/found. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Time to Reach HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND
|
70.3 weeks
Interval 24.6 to
NA stands for upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
124.1 weeks
Interval 64.3 to
NA stands for upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
14.1 weeks
Interval 12.0 to
NA stands for upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
NA weeks
Interval 54.9 to
NA stands for median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 48Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure.
Change from baseline in HDV RNA was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=8 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in HDV RNA
|
-1.66 log10 IU/mL
Standard Error 0.393
|
-0.23 log10 IU/mL
Standard Error 0.150
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 48Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure.
Change from baseline in HDV RNA was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=15 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in HDV RNA
|
-2.09 log10 IU/mL
Standard Error 0.294
|
-0.19 log10 IU/mL
Standard Error 0.199
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Change from baseline in ALT was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=9 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in ALT
Week 48
|
0.89 Enzyme unit per liter (U/L)
Standard Error 26.068
|
-33.80 Enzyme unit per liter (U/L)
Standard Error 19.345
|
—
|
—
|
|
Part 1: Change From Baseline in ALT
FU Week 24
|
-21.67 Enzyme unit per liter (U/L)
Standard Error 25.012
|
-5.25 Enzyme unit per liter (U/L)
Standard Error 49.082
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 48, FU Week 44Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Change from baseline in ALT was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=15 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in ALT
Week 48
|
-36.33 Enzyme U/L
Standard Error 11.611
|
-25.50 Enzyme U/L
Standard Error 14.692
|
—
|
—
|
|
Part 2: Change From Baseline in ALT
FU Week 44
|
-9.69 Enzyme U/L
Standard Error 33.984
|
-25.00 Enzyme U/L
Standard Error 10.863
|
—
|
—
|
SECONDARY outcome
Timeframe: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192Population: Safety analysis set included all participants who took at least 1 dose of study intervention. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with TEAEs was reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention. TEAE were all AEs with a start date on or after the first administration of study treatment or any ongoing event that worsens in severity, intensity or frequency after the first administration of study treatment.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
DB Phase
|
100.0 Percentage of participants
Interval 60.0 to
|
60.0 Percentage of participants
|
83.3 Percentage of participants
|
83.3 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Open-Label Phase
|
80.0 Percentage of participants
|
100.0 Percentage of participants
|
57.1 Percentage of participants
|
60.0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Follow-up Phase
|
78.6 Percentage of participants
|
75.0 Percentage of participants
|
36.8 Percentage of participants
|
40.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192Population: Safety analysis set included all participants who take at least 1 dose of study intervention. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with TESAEs was reported. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TESAE were all SAEs with a start date on or after the first administration of study treatment or any ongoing event that worsens in severity, intensity or frequency after the first administration of study treatment.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
DB Phase
|
11.8 Percentage of participants
Interval 60.0 to
|
0 Percentage of participants
|
12.5 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Open-Label Phase
|
0 Percentage of participants
|
25.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Follow-up Phase
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192Population: Safety analysis set included all participants who take at least 1 dose of study intervention. Here, "n" (number analyzed) refer to number of participants evaluable for specified categories.
Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: chemistry was reported. Laboratory abnormalities were graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening. Only Grade 3 and Grade 4 abnormalities were considered worst and are reported. Only those laboratory parameters for which at least one participant had an abnormality are reported in this outcome measure. ALT: Alanine Aminotransferase; AST: Aspartate Aminotransferase; SGPT: serum glutamic pyruvic transaminase; SGOT: serum glutamic-oxaloacetic transaminase.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
DB Phase: ALT or SGPT, High: Grade 3
|
23.5 Percentage of participants
Interval 60.0 to
|
0 Percentage of participants
|
8.3 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
DB Phase: ALT or SGPT, High: Grade 4
|
41.2 Percentage of participants
|
0 Percentage of participants
|
16.7 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
DB Phase: AST or SGOT, High: Grade 3
|
23.5 Percentage of participants
|
0 Percentage of participants
|
8.3 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
DB Phase: AST or SGOT, High: Grade 4
|
23.5 Percentage of participants
|
0 Percentage of participants
|
12.5 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
DB Phase: Creatine Kinase, High: Grade 4
|
5.9 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
DB Phase: Direct Bilirubin, High: Grade 3
|
29.4 Percentage of participants
|
20.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
DB Phase: Phosphate, Low: Grade 4
|
5.9 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
DB Phase: Sodium, Low: Grade 4
|
0 Percentage of participants
|
20.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
OL phase: ALT or SGPT, High: Grade 3
|
40.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
20.0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
OL phase: ALT or SGPT, High: Grade 4
|
0 Percentage of participants
|
50.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
OL phase: AST or SGOT, High: Grade 3
|
20.0 Percentage of participants
|
25.0 Percentage of participants
|
7.1 Percentage of participants
|
20.0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
OL phase: Creatine Kinase, High: Grade 4
|
20.0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
FU Phase: ALT or SGPT, High: Grade 3
|
42.9 Percentage of participants
|
25.0 Percentage of participants
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
FU Phase: ALT or SGPT, High: Grade 4
|
7.1 Percentage of participants
|
25.0 Percentage of participants
|
16.7 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
FU Phase: AST or SGOT, High: Grade 3
|
35.7 Percentage of participants
|
25.0 Percentage of participants
|
22.2 Percentage of participants
|
25.0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
FU Phase: AST or SGOT, High: Grade 4
|
0 Percentage of participants
|
0 Percentage of participants
|
5.6 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
FU Phase: Direct Bilirubin, High: Grade 3
|
42.9 Percentage of participants
|
25.0 Percentage of participants
|
5.6 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
FU Phase: Direct Bilirubin, High: Grade 4
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Placebo + NA: DB Phase: Week 0 up to Week 52; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52Population: Safety analysis set included all participants who take at least 1 dose of study intervention.
Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: hematology was reported. Laboratory abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening. Only Grade 3 and Grade 4 abnormalities were considered worst and are reported. Only those laboratory parameters for which at least one participant had an abnormality are reported in this outcome measure.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Hematology
DB Phase: Absolute Lymphocyte Count, Low: Grade 3
|
0 Percentage of participants
|
0 Percentage of participants
|
4.2 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Hematology
DB Phase: Absolute Lymphocyte Count, Low: Grade 4
|
0 Percentage of participants
|
0 Percentage of participants
|
4.2 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192Population: Safety analysis set included all participants who take at least 1 dose of study intervention. "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: urinalysis was reported. Urinalysis included parameters: Glycosuria, Hematuria, and Proteinuria. Laboratory abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening. Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urinalysis
DB Phase: Grade 4
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urinalysis
DB Phase: Grade 3
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urinalysis
OL Phase: Grade 3
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urinalysis
OL Phase: Grade 4
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urinalysis
FU Phase: Grade 3
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urinalysis
FU Phase: Grade 4
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192Population: Safety analysis set included all participants who take at least 1 dose of study intervention. "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: urine chemistry was reported. Laboratory abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening. Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urine Chemistry
DB Phase: Grade 3
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urine Chemistry
DB Phase: Grade 4
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urine Chemistry
OL Phase: Grade 3
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urine Chemistry
OL Phase: Grade 4
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urine Chemistry
FU Phase: Grade 3
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urine Chemistry
FU Phase: Grade 4
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192Population: Safety analysis set included all participants who take at least 1 dose of study intervention. "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: renal biomarkers was reported. Laboratory abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening. Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Renal Biomarkers
DB Phase: Grade 3
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Renal Biomarkers
DB Phase: Grade 4
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Renal Biomarkers
OL Phase: Grade 3
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Renal Biomarkers
OL Phase: Grade 4
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Renal Biomarkers
FU Phase: Grade 3
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Renal Biomarkers
FU Phase: Grade 4
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192Population: Safety analysis set included all participants who take at least 1 dose of study intervention. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints. Due to change in planned analysis, number of participants and absence of medical relevance to have separated analysis, it was decided to only have combined results.
Percentage of participants with worst treatment-emergent abnormalities in 12-Lead Electrocardiogram was reported. Only those parameters were reported where at least one participant had abnormality. Worst ECG abnormalities were determined based on investigator's discretion. bpm: beats per minute; ms: milliseconds; QTcF: QT interval corrected for heart rate according to Fridericia; QTc: Corrected QT Interval.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=41 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=11 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in 12-Lead Electrocardiogram
DB: Mean Heart Rate: Abnormally Low (<45 bpm)
|
2.4 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in 12-Lead Electrocardiogram
DB: QTcF Interval: Borderline prolonged QT (450 ms < QTc <=480 ms)
|
4.9 Percentage of participants
|
9.1 Percentage of participants
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in 12-Lead Electrocardiogram
OL: Mean Heart Rate Abnormally Low (<45 bpm)
|
5.6 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in 12-Lead Electrocardiogram
OL: Borderline prolonged QT (450 ms < QTc <=480 ms)
|
5.6 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in 12-Lead Electrocardiogram
FU: Borderline prolonged QT (450 ms < QTc <=480 ms)
|
0 Percentage of participants
|
12.5 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144Population: Safety analysis set included all participants who take at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified categories. Due to change in planned analysis, number of participants and absence of medical relevance to have separated analysis, it was decided to only have combined results.
Percentage of participants with worst treatment-emergent abnormalities in vital signs (pulse rate, supine systolic blood pressure). Vital signs abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening. Only Grade 3 and Grade 4 abnormalities were considered worst and are reported. Only those laboratory parameters for which at least one participant had an abnormality are reported in this outcome measure. Only those parameters were reported where at least one participant had abnormality. Abn: abnormal
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=2 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Vital Signs
DB: Pulse Rate: Abn. Low
|
50.0 Percentage of participants
|
—
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Vital Signs
DB: Pulse Rate: Abn. High
|
50.0 Percentage of participants
|
—
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Vital Signs
OL: Pulse Rate: Abn. Low
|
100.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192Population: Safety analysis set included all participants who take at least 1 dose of study intervention. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with clinically significant abnormalities in physical examination was reported. Vital signs abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Clinically Significant Abnormalities in Physical Examination
OL Phase
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Clinically Significant Abnormalities in Physical Examination
DB Phase
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Clinically Significant Abnormalities in Physical Examination
FU Phase
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, N (Overall number of participants analyzed) refer to participants who were analyzed for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified categories.
Percentage of participants with HBsAg seroclearance was reported. HBsAg seroclearance is defined as the quantitative HBsAg \< LLOQ.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=10 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=4 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=16 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance
Week 48
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance
FU Week 24
|
0 Percentage of participants
|
0 Percentage of participants
|
2 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Change from baseline over time in HBsAg was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=10 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline Over Time in HBsAg
Week 48
|
-1.78 log10 IU/mL
Standard Error 0.274
|
-0.07 log10 IU/mL
Standard Error 0.040
|
—
|
—
|
|
Part 1: Change From Baseline Over Time in HBsAg
FU Week 24
|
-0.75 log10 IU/mL
Standard Error 0.349
|
-1.12 log10 IU/mL
Standard Error 0.708
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Change from baseline over time in HBsAg was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=14 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline Over Time in HBsAg
Week 48
|
-2.44 log10 IU/mL
Standard Error 0.238
|
-0.02 log10 IU/mL
Standard Error 0.026
|
—
|
—
|
|
Part 2: Change From Baseline Over Time in HBsAg
FU Week 24
|
-1.69 log10 IU/mL
Standard Error 0.405
|
-0.87 log10 IU/mL
Standard Error 0.421
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 48, FU Week 24Population: ITT set was used. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints. n=0 indicated that no participant was available for the analysis.
Change from baseline over time in HBeAg was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=1 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=2 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline Over Time in Hepatitis B Virus e Antigen (HBeAg)
Week 48
|
-0.90 log10 IU/mL
Standard Error NA
NA stands for SE not estimable for single participant.
|
-0.02 log10 IU/mL
Standard Error 0.022
|
—
|
—
|
|
Part 1: Change From Baseline Over Time in Hepatitis B Virus e Antigen (HBeAg)
FU Week 24
|
—
|
-0.06 log10 IU/mL
Standard Error NA
NA stands for SE not estimable for single participant.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 48, FU Week 24Population: ITT set was used. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints. n=0 indicated that no participant was available for the analysis.
Change from baseline over time in HBeAg was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=1 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=1 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline Over Time in HBeAg
Week 48
|
—
|
0.07 log10 IU/mL
Standard Error NA
NA stands for SE not estimable for single participant.
|
—
|
—
|
|
Part 2: Change From Baseline Over Time in HBeAg
FU Week 24
|
-0.44 log10 IU/mL
Standard Error NA
NA stands for SE not estimable for single participant.
|
0.06 log10 IU/mL
Standard Error NA
NA stands for SE not estimable for single participant.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 48 , 136, EOS (FU Week 48)Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Change from baseline over time in HBV DNA was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=12 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline Over Time in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA)
Week 48
|
-0.14 log10 IU/mL
Standard Error 0.183
|
-0.19 log10 IU/mL
Standard Error 0.117
|
—
|
—
|
|
Part 1: Change From Baseline Over Time in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA)
Week 136
|
-0.37 log10 IU/mL
Standard Error 0.275
|
-0.48 log10 IU/mL
Standard Error NA
NA stands for SE not estimable for single participant.
|
—
|
—
|
|
Part 1: Change From Baseline Over Time in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA)
FU Week 48
|
-0.15 log10 IU/mL
Standard Error 0.160
|
-0.08 log10 IU/mL
Standard Error 0.139
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 48, 112, EOS (FU Week 48)Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Change from baseline over time in HBV DNA was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=15 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline Over Time in HBV DNA
Week 48
|
-0.29 log10 IU/mL
Standard Error 0.267
|
-0.54 log10 IU/mL
Standard Error 0.299
|
—
|
—
|
|
Part 2: Change From Baseline Over Time in HBV DNA
Week 112
|
-0.62 log10 IU/mL
Standard Error 0.506
|
0.00 log10 IU/mL
Standard Error 0.000
|
—
|
—
|
|
Part 2: Change From Baseline Over Time in HBV DNA
FU Week 48
|
-0.27 log10 IU/mL
Standard Error 0.128
|
-0.48 log10 IU/mL
Standard Error 0.453
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HBsAg levels below/above different cut-offs was reported. HBsAg values (IU/mL) were \<1,000, \<100, \<10, \<1, and \<0.05 IU/mL (i.e, \<LLOQ). LLOQ value is 0.05 IU/mL.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=10 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Week 48: < LLOQ
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Week 48: < 1 IU/mL
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Week 48: < 10 IU/mL
|
11.1 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Week 48: < 100 IU/mL
|
55.6 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Week 48: < 1000 IU/mL
|
77.8 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
FU Week 24: < LLOQ
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
FU Week 24: < 1 IU/mL
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
FU Week 24: < 10 IU/mL
|
10.0 Percentage of participants
|
25.0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
FU Week 24: < 100 IU/mL
|
30.0 Percentage of participants
|
25.0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
FU Week 24: < 1000 IU/mL
|
30.0 Percentage of participants
|
25.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints. n=0 indicated that no participant was available for the analysis.
Percentage of participants with HBsAg levels below/above different cut-offs was reported. HBsAg values (IU/mL) were \<1,000, \<100, \<10, \<1, and \<0.05 IU/mL (i.e, \<LLOQ). LLOQ value is 0.05 IU/mL.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=14 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Week 48: < LLOQ
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Week 48: < 1 IU/mL
|
7.1 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Week 48: < 10 IU/mL
|
50.0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Week 48: < 100 IU/mL
|
78.6 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Week 48: < 1000 IU/mL
|
100.0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
FU Week 24: < LLOQ
|
7.7 Percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
FU Week 24: < 1 IU/mL
|
15.4 Percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
FU Week 24: < 10 IU/mL
|
30.8 Percentage of participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
FU Week 24: < 100 IU/mL
|
46.2 Percentage of participants
|
25.0 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
FU Week 24: < 1000 IU/mL
|
69.2 Percentage of participants
|
75.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints. n=0 indicated that no participant was available for the analysis.
Percentage of participants with HBeAg levels below/above different cut-offs was reported. Cut-offs were \>= 0.5 log10 IU/mL, \>= 1.0 log10 IU/mL, \>= 2.0 log10 IU/mL, and \>= 3.0 log10 IU/mL.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=1 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=1 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
Week 48: >= 0.5 log10 IU/mL
|
100 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
Week 48: >= 1.0 log10 IU/mL
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
Week 48: >= 2.0 log10 IU/mL
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
Week 48: >= 3.0 log10 IU/mL
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
FU Week 24: >= 0.5 log10 IU/mL
|
—
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
FU Week 24: >= 1.0 log10 IU/mL
|
—
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
FU Week 24: >= 2.0 log10 IU/mL
|
—
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
FU Week 24: >= 3.0 log10 IU/mL
|
—
|
0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints. n=0 indicated that no participant was available for the analysis.
Percentage of participants with HBeAg levels below/above different cut-offs was reported. Cut-offs were \>= 0.5 log10 IU/mL, \>= 1.0 log10 IU/mL, \>= 2.0 log10 IU/mL, and \>= 3.0 log10 IU/mL.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=1 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=1 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
Week 48: >= 0.5 log10 IU/mL
|
—
|
0 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
Week 48: >= 1.0 log10 IU/mL
|
—
|
0 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
Week 48: >= 2.0 log10 IU/mL
|
—
|
0 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
Week 48: >= 3.0 log10 IU/mL
|
—
|
0 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
FU Week 24: >= 0.5 log10 IU/mL
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
FU Week 24: >= 1.0 log10 IU/mL
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
FU Week 24: >= 2.0 log10 IU/mL
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
FU Week 24: >= 3.0 log10 IU/mL
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HBV DNA levels below/above different cut-offs (\<LLOQ and \<2000 IU/mL) was reported. For HBV DNA, LLOQ is 20 IU/mL.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=5 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=3 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With HBV DNA Levels Below/Above Different Cut-offs
Week 48: < LLOQ
|
100 Percentage of participants
|
100 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBV DNA Levels Below/Above Different Cut-offs
Week 48: < 2000 IU/mL
|
100 Percentage of participants
|
100 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBV DNA Levels Below/Above Different Cut-offs
FU Week 24: < LLOQ
|
100 Percentage of participants
|
100 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBV DNA Levels Below/Above Different Cut-offs
FU Week 24: < 2000 IU/mL
|
100 Percentage of participants
|
100 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HBV DNA levels below/above different cut-offs (\<LLOQ and \<2000 IU/mL). For HBV DNA, LLOQ is 20 IU/mL
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=12 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=4 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With HBV DNA Levels Below/Above Different Cut-offs
Week 48: < LLOQ
|
100 Percentage of participants
|
100 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBV DNA Levels Below/Above Different Cut-offs
Week 48: < 2000 IU/mL
|
100 Percentage of participants
|
100 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBV DNA Levels Below/Above Different Cut-offs
FU Week 24: < LLOQ
|
100 Percentage of participants
|
100 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBV DNA Levels Below/Above Different Cut-offs
FU Week 24: < 2000 IU/mL
|
100 Percentage of participants
|
100 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Placebo + NA: From baseline up to Week 196; JNJ-3989 + NA: From baseline up to Week 192Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to.
Time to reach HBsAg \<1 IU/mL based on Kaplan-Meier estimate was reported. Time to first occurrence of the HBsAg \<1 IU/mL is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBsAg \<1 IU/mL. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Time to Reach HBsAg <1 IU/mL Based on Kaplan-Meier Estimate
|
NA Days
NA stands for median, lower, and upper limit of 95% CI could not be calculated as less than 10% of the participants experienced the event.
|
NA Days
NA stands for median, lower, and upper limit of 95% CI could not be calculated as less than 10% of the participants experienced the event.
|
—
|
—
|
SECONDARY outcome
Timeframe: Placebo + NA: From baseline up to Week 196; JNJ-3989 + NA: From baseline up to Week 192Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. N=0 indicated that since there were no participant with events, data was not collected.
Time to reach HBsAg \<1 IU/mL based on Kaplan-Meier estimate was reported. Time to first occurrence of the HBsAg \<1 IU/mL is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBsAg \<1 IU/mL. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Time to Reach HBsAg <1 IU/mL Based on Kaplan-Meier Estimate
|
NA Days
NA stands for median, lower, and upper limit of 95% CI could not be calculated as no participants had events.
|
NA Days
Interval 103.9 to
NA stands for median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HBV DNA virologic breakthrough was reported. Virologic Breakthrough was defined as confirmed on-treatment HBV DNA increase by \>1 log10 IU/mL from nadir or confirmed on-treatment HBV DNA level \>200 IU/mL in participants who had HBV DNA level \<LLOQ of the HBV DNA assay.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=10 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With HBV DNA Virologic Breakthrough
Week 48
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBV DNA Virologic Breakthrough
FU Week 24
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Percentage of participants with HBV DNA virologic breakthrough was reported. Virologic Breakthrough was defined as confirmed on-treatment HBV DNA increase by \>1 log10 IU/mL from nadir or confirmed on-treatment HBV DNA level \>200 IU/mL in participants who had HBV DNA level \<LLOQ of the HBV DNA assay.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=14 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With HBV DNA Virologic Breakthrough
Week 48
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Part 2: Percentage of Participants With HBV DNA Virologic Breakthrough
FU Week 24
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, and 16Population: PK analysis set was defined as participants who have received at least 1 dose of any of the study treatments and have at least 1 valid blood sample drawn for PK analysis. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Per change in planned analysis, PK data was combined for parts 1 and 2 due to the insufficient number of participants.
Maximum plasma concentration (Cmax) of JNJ-3976 were reported. Participant wise data is reported as n\<3.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=1 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of JNJ-3976
Week 4
|
488 nanograms per milliliter (ng/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
|
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of JNJ-3976
Week 8
|
919 nanograms per milliliter (ng/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
|
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of JNJ-3976
Week 16
|
1016 nanograms per milliliter (ng/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, and 16Population: The Pharmacokinetics (PK) analysis set was defined as participants who have received at least 1 dose of any of the study treatments and have at least 1 valid blood sample drawn for PK analysis. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Per change in planned analysis, the PK data was combined for parts 1 and 2 due to the insufficient number of participants.
Maximum plasma concentration (Cmax) of JNJ-3924 was reported. Participant wise data is reported as n\<3.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=1 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of JNJ-3924
Week 4
|
114 nanograms per milliliter (ng/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
|
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of JNJ-3924
Week 8
|
141 nanograms per milliliter (ng/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
|
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of JNJ-3924
Week 16
|
195 nanograms per milliliter (ng/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose up to 24 hours post dose on Weeks 4, 8, and 16Population: The Pharmacokinetics (PK) analysis set was defined as participants who have received at least 1 dose of any of the study treatments and have at least 1 valid blood sample drawn for PK analysis. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Per change in planned analysis, the PK data was combined for parts 1 and 2 due to the insufficient number of participants.
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC\[0-24h\]) of JNJ-3976 were reported. Participant wise data is reported as n\<3.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=1 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-3976
Week 4
|
7027 nanograms*hours per milliliter (ng*h/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-3976
Week 8
|
11183 nanograms*hours per milliliter (ng*h/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-3976
Week 16
|
13577 nanograms*hours per milliliter (ng*h/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose up to 24 hours post dose on Weeks 4, 8, and 16Population: The Pharmacokinetics (PK) analysis set was defined as participants who have received at least 1 dose of any of the study treatments and have at least 1 valid blood sample drawn for PK analysis. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Per change in planned analysis, the PK data was combined for parts 1 and 2 due to the insufficient number of participants.
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC\[0-24h\]) of JNJ-3924 were reported. Participant wise data is reported as n\<3.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=1 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-3924
Week 4
|
1506 nanograms*hours per milliliter (ng*h/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-3924
Week 8
|
1813 nanograms*hours per milliliter (ng*h/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-3924
Week 16
|
2657 nanograms*hours per milliliter (ng*h/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, and 16Population: The Pharmacokinetics (PK) analysis set was defined as participants who have received at least 1 dose of any of the study treatments and have at least 1 valid blood sample drawn for PK analysis. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Per change in planned analysis, the PK data was combined for parts 1 and 2 due to the insufficient number of participants.
Area under the plasma concentration-time curve from time 0 to Last Quantifiable Time (AUC\[0-last\]) of JNJ-3976 were reported. Participant wise data is reported as n\<3.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=1 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3976
Week 4
|
7027 nanograms*hours per milliliter (ng*h/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3976
Week 8
|
11183 nanograms*hours per milliliter (ng*h/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3976
Week 16
|
13577 nanograms*hours per milliliter (ng*h/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, and 16Population: The Pharmacokinetics (PK) analysis set was defined as participants who have received at least 1 dose of any of the study treatments and have at least 1 valid blood sample drawn for PK analysis. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Per change in planned analysis, the PK data was combined for parts 1 and 2 due to the insufficient number of participants.
Area under the plasma concentration-time curve from time 0 to Last Quantifiable Time (AUC\[0-last\]) of JNJ-3924 were reported. Participant wise data is reported as n\<3.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=1 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3924
Week 4
|
1506 nanograms*hours per milliliter (ng*h/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3924
Week 8
|
1813 nanograms*hours per milliliter (ng*h/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3924
Week 16
|
2657 nanograms*hours per milliliter (ng*h/mL)
Standard Deviation NA
NA refers to standard deviation data not estimable for single participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, EOS (FU Week 48)Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure.
Percentage of participants with \>=2 kPa reduction from baseline \>=2 kPa in liver stiffness measurement (LSM) assessed by VCTE (fibroScan) was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=6 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With >=2 Kilopascals (kPa) Reduction From Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE; FibroScan)
|
50.0 Percentage of participants
|
20.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, EOS (FU Week 48)Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure.
Percentage of participants with \>=2 kPa reduction from baseline in liver stiffness measurement (LSM) assessed by VCTE (FibroScan) was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=12 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=4 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With >=2 kPa Reduction From Baseline in Liver Stiffness Measurement (LSM) Assessed by VCTE (FibroScan)
|
25.0 Percentage of participants
|
25.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Change from baseline in LSM over time assessed by VCTE (FibroScan) was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=9 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in LSM Over Time Assessed by VCTE (FibroScan)
Week 48
|
0.42 kilopascals (kPa)
Standard Error 1.740
|
1.74 kilopascals (kPa)
Standard Error 2.309
|
—
|
—
|
|
Part 1: Change From Baseline in LSM Over Time Assessed by VCTE (FibroScan)
FU Week 24
|
3.87 kilopascals (kPa)
Standard Error 2.442
|
4.38 kilopascals (kPa)
Standard Error 3.066
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48, FU Week 24Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified timepoints.
Change from baseline in LSM over time assessed by VCTE (FibroScan) was reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=12 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=4 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in LSM Over Time Assessed by VCTE (FibroScan)
Week 48
|
-1.10 kilopascals (kPa)
Standard Error 0.413
|
0.08 kilopascals (kPa)
Standard Error 1.424
|
—
|
—
|
|
Part 2: Change From Baseline in LSM Over Time Assessed by VCTE (FibroScan)
FU Week 24
|
2.78 kilopascals (kPa)
Standard Error 1.573
|
-0.20 kilopascals (kPa)
Standard Error 0.252
|
—
|
—
|
SECONDARY outcome
Timeframe: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure.
Percentage of participants with sustained HDV response Off-treatment post end of JNJ-3989 treatment was reported. A JNJ-3989 off-treatment sustained HDV response is defined by having HDV RNA TND during the FU phase after stopping JNJ-3989 regardless of continuing NA treatment.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=11 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=3 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With Sustained HDV Response Off-treatment Post End of JNJ-3989 Treatment
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure.
Percentage of participants with sustained HDV response Off-treatment post end of JNJ-3989 treatment was reported. A JNJ-3989 off-treatment sustained HDV response is defined by having HDV RNA TND during the FU phase after stopping JNJ-3989 regardless of continuing NA treatment.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=4 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With Sustained HDV Response Off-treatment Post End of JNJ-3989 Treatment
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to.
Percentage of participants with HDV relapse post end of JNJ-3989 treatment was reported. Off-treatment HDV relapse is defined as: 1. In participants with HDV RNA \<LLOQ (i.e., 630 IU/ml) at EOT: Confirmed increase in HDV RNA of \> 1 log10 IU/mL above the LLOQ JNJ-3989 off-treatment. 2. In participants with HDV RNA \>LLOQ at EOT: Confirmed increase in HDV RNA of \> 1 log10 IU/mL from EOT HDV RNA value JNJ-3989 off-treatment.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With HDV Relapse Post End of JNJ-3989 Treatment
|
52.9 Percentage of Participants
|
60.0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to.
Percentage of participants with HDV relapse post end of JNJ-3989 treatment was reported. Off-treatment HDV relapse is defined as: 1. In participants with HDV RNA \<LLOQ (i.e., 630 IU/ml) at EOT: Confirmed increase in HDV RNA of \> 1 log10 IU/mL above the LLOQ JNJ-3989 off-treatment. 2. In participants with HDV RNA \>LLOQ at EOT: Confirmed increase in HDV RNA of \> 1 log10 IU/mL from EOT HDV RNA value JNJ-3989 off-treatment.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=24 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=6 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With HDV Relapse Post End of JNJ-3989 Treatment
|
29.2 Percentage of Participants
|
66.7 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure.
Percentage of participants with sustained HBV response off-treatment post end of JNJ-3989 treatment was reported.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=14 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=4 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
n=18 Participants
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
n=4 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Sustained HBV Response Off-treatment Post End of JNJ-3989 Treatment
|
7.1 Percentage of participants
|
0 Percentage of participants
|
27.8 Percentage of participants
|
25.0 Percentage of participants
|
SECONDARY outcome
Timeframe: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to. Here, "n" (number analyzed) refer to number of participants evaluable at specified categories. Here, n=0 refers to no participants were available for evaluation at specified categories.
Percentage of participants with HBV flare (Virologic, biochemical, and clinical) post end of treatment was reported. Off-treatment is defined as the time period as the periods when the participants do not receive any of the study interventions (JNJ-3989/placebo and NA). Virologic flare is for participants who are off-treatment and had HBV DNA \< LLOQ at the last observed point on all study treatments, and categorized based on the confirmed (i.e., two consecutive values) peak HBV DNA above any of the three thresholds: 20000 IU/mL, 2000 IU/mL and 200 IU/mL. Biochemical HBV flare is defined as a confirmed ALT and/or AST\>=3\*ULN and \>=3\* nadir (i.e. lowest value observed up to the time point of meeting the biochemical flare criteria). An HBV clinical flare occurs either when an HBV virologic flare and off-treatment HBV biochemical flare overlap in time or when a HBV biochemical flare starts within 4 weeks following the end of an HBV virologic flare.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=17 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
n=5 Participants
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With HBV Flare (Virologic, Biochemical, and Clinical) Post End of Treatment
Off-Treatment Virologic HBV Flare
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
|
Part 1: Percentage of Participants With HBV Flare (Virologic, Biochemical, and Clinical) Post End of Treatment
Off-Treatment Biochemical HBV Flares
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Part 1: Percentage of Participants With HBV Flare (Virologic, Biochemical, and Clinical) Post End of Treatment
Off-Treatment Clinical HBV Flares
|
0 Percentage of Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48Population: ITT included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. Here, "n" (number analyzed) refer to number of participants evaluable at specified categories. Here, n=0 refers to no participants were available for evaluation at specified categories.
Percentage of participants with HBV flare (Virologic, biochemical, and clinical) post end of treatment was reported was reported. Off-treatment is defined as the time period as the periods when the participants do not receive any of the study interventions (JNJ-3989/placebo and NA). Virologic flare (Derivation 1) is for participants who are off-treatment and had HBV DNA \< LLOQ at the last observed point on all study treatments, and categorized based on the confirmed (i.e., two consecutive values) peak HBV DNA above any of the three thresholds: 20000 IU/mL, 2000 IU/mL and 200 IU/mL. Biochemical HBV flare is defined as a confirmed ALT and/or AST\>=3\*ULN and \>=3\* nadir (i.e. lowest value observed up to the time point of meeting the biochemical flare criteria). An HBV clinical flare occurs either when an HBV virologic flare and off-treatment HBV biochemical flare overlap in time or when a HBV biochemical flare starts within 4 weeks following the end of an HBV virologic flare.
Outcome measures
| Measure |
Part 1: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA)
n=3 Participants
In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 1: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
Part 2: JNJ-73763989 (JNJ-3989) + NA
In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per protocol amendment (PA) 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
Part 2: Placebo + NA
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone. After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and follow up was reduced from 48 weeks to 24 weeks. Per PA 5, the end of open-label was fixed to Week 96 and FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With HBV Flare (Virologic, Biochemical, and Clinical) Post End of Treatment
Off-Treatment Virologic HBV Flare
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With HBV Flare (Virologic, Biochemical, and Clinical) Post End of Treatment
Off-Treatment Biological HBV Flare
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With HBV Flare (Virologic, Biochemical, and Clinical) Post End of Treatment
Off-Treatment Clinical HBV Flare
|
0 Percentage of Participants
|
—
|
—
|
—
|
Adverse Events
OL Phase: Part 1: Placebo + NA
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
OL Phase: Part 2: JNJ-73763989 + NA
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
OL Phase: Part 2: Placebo + NA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
FU Phase: Part 1: JNJ-73763989 + NA
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
FU Phase: Part 1: Placebo + NA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
FU Phase: Part 2: JNJ-73763989 + NA
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
FU Phase: Part 2: Placebo + NA
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DB Phase: Part 1: JNJ-73763989 + NA
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
DB Phase: Part 1: Placebo + NA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DB Phase: Part 2: JNJ-73763989+ NA
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
DB Phase: Part 2: Placebo + NA
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
OL Phase: Part 1: JNJ-73763989 + NA
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OL Phase: Part 1: Placebo + NA
n=4 participants at risk
After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148).
|
OL Phase: Part 2: JNJ-73763989 + NA
n=14 participants at risk
After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ- 73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and the end of open-label was fixed to Week 96 or to the next planned visit following implementation of PA 5.
|
OL Phase: Part 2: Placebo + NA
n=5 participants at risk
After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and the end of open-label was fixed to Week 96 or to the next planned visit following implementation of PA 5.
|
FU Phase: Part 1: JNJ-73763989 + NA
n=14 participants at risk
After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
FU Phase: Part 1: Placebo + NA
n=4 participants at risk
After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
FU Phase: Part 2: JNJ-73763989 + NA
n=19 participants at risk
After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued. After protocol amendment 5 for part 2, follow up was reduced from 48 weeks to 24 weeks. Per PA 5, FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
FU Phase: Part 2: Placebo + NA
n=5 participants at risk
After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued. After protocol amendment 5 for part 2, follow up was reduced from 48 weeks to 24 weeks. Per PA 5, FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
DB Phase: Part 1: JNJ-73763989 + NA
n=17 participants at risk
In the double-blind phase, participants received JNJ- 73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks.
|
DB Phase: Part 1: Placebo + NA
n=5 participants at risk
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.
|
DB Phase: Part 2: JNJ-73763989+ NA
n=24 participants at risk
In the double-blind phase, participants received JNJ- 73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks.
|
DB Phase: Part 2: Placebo + NA
n=6 participants at risk
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.
|
OL Phase: Part 1: JNJ-73763989 + NA
n=5 participants at risk
After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ- 73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary Artery Disease
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Eye disorders
Keratitis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Investigations
Transaminases Increased
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Reproductive system and breast disorders
Intermenstrual Bleeding
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
Other adverse events
| Measure |
OL Phase: Part 1: Placebo + NA
n=4 participants at risk
After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148).
|
OL Phase: Part 2: JNJ-73763989 + NA
n=14 participants at risk
After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ- 73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and the end of open-label was fixed to Week 96 or to the next planned visit following implementation of PA 5.
|
OL Phase: Part 2: Placebo + NA
n=5 participants at risk
After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After protocol amendment 5 for part 2, open-label phase was reduced to up to Week 96 and the end of open-label was fixed to Week 96 or to the next planned visit following implementation of PA 5.
|
FU Phase: Part 1: JNJ-73763989 + NA
n=14 participants at risk
After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
FU Phase: Part 1: Placebo + NA
n=4 participants at risk
After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
|
FU Phase: Part 2: JNJ-73763989 + NA
n=19 participants at risk
After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued. After protocol amendment 5 for part 2, follow up was reduced from 48 weeks to 24 weeks. Per PA 5, FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
FU Phase: Part 2: Placebo + NA
n=5 participants at risk
After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued. After protocol amendment 5 for part 2, follow up was reduced from 48 weeks to 24 weeks. Per PA 5, FU phase was fixed to Week 24 or to the next planned visit following implementation of PA 5.
|
DB Phase: Part 1: JNJ-73763989 + NA
n=17 participants at risk
In the double-blind phase, participants received JNJ- 73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks.
|
DB Phase: Part 1: Placebo + NA
n=5 participants at risk
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.
|
DB Phase: Part 2: JNJ-73763989+ NA
n=24 participants at risk
In the double-blind phase, participants received JNJ- 73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily for 52 weeks.
|
DB Phase: Part 2: Placebo + NA
n=6 participants at risk
In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.
|
OL Phase: Part 1: JNJ-73763989 + NA
n=5 participants at risk
After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ- 73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
11.8%
2/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Ear and labyrinth disorders
Motion Sickness
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Eye disorders
Blepharitis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.3%
1/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
23.5%
4/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
11.8%
2/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
17.6%
3/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
8.3%
2/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
33.3%
2/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Varices Oesophageal
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
11.8%
2/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
12.5%
3/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.3%
1/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
23.5%
4/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
8.3%
2/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
General disorders
Feeling Hot
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
General disorders
Injection Site Pain
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
General disorders
Vessel Puncture Site Swelling
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Autoimmune Hepatitis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Gallbladder Polyp
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hepatic Fibrosis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
11.8%
2/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Liver Disorder
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.3%
1/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.3%
1/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Covid-19
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
11.8%
2/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Furuncle
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Helicobacter Infection
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
10.5%
2/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
12.5%
3/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Localised Infection
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Tooth Abscess
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.3%
1/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
8.3%
2/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
50.0%
3/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Face Injury
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Limb Crushing Injury
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Investigations
Alanine Aminotransferase Increased
|
50.0%
2/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
40.0%
2/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
21.4%
3/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
21.1%
4/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
52.9%
9/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
33.3%
8/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Investigations
Amylase Increased
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Investigations
Aspartate Aminotransferase Increased
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
21.4%
3/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
10.5%
2/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
41.2%
7/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
4/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Investigations
Bilirubin Conjugated Increased
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
11.8%
2/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Investigations
Transaminases Increased
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
14.3%
2/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
11.8%
2/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Investigations
Weight Decreased
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
11.8%
2/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
8.3%
2/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Bone Cyst
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
11.8%
2/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
8.3%
2/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
21.4%
3/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.3%
1/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
23.5%
4/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
8.3%
2/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Nervous system disorders
Intercostal Neuralgia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
11.8%
2/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.3%
1/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
14.3%
2/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Psychiatric disorders
Personality Disorder
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Psychiatric disorders
Self-Injurious Ideation
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Reproductive system and breast disorders
Heavy Menstrual Bleeding
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.3%
1/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
11.8%
2/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Pigmentation Disorder
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
11.8%
2/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
8.3%
2/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Umbilical Erythema
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
20.0%
1/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
4.2%
1/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
5.9%
1/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
16.7%
1/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
11.8%
2/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
7.1%
1/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
|
Cardiac disorders
Coronary Artery Disease
|
25.0%
1/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/14 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/4 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/19 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/17 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/24 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/6 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
0.00%
0/5 • Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
Safety analysis set included all participants who take at least 1 dose of study intervention.
|
Additional Information
Senior Director Medical Lead
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER