Trial Outcomes & Findings for Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine (NCT NCT05107115)
NCT ID: NCT05107115
Last Updated: 2026-08-06
Results Overview
The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease. Baseline is defined as the sum of the 7 days measurements obtained on and prior to the target visit day.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2026-08-06
Participant Flow
The study was conducted at 59 active centers in 13 countries. A total of 240 participants were screened between 24 November 2021 and 28 February 2023, of which 80 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.
A total of 160 participants were enrolled in the study. Randomization was stratified by region and prior use of omalizumab.
Participant milestones
| Measure |
DB Period: Placebo TID
Participants received 1 tablet of matching placebo orally TID from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg QPM + Placebo
Participants received 1 tablet of rilzabrutinib 400 milligrams (mg) orally once every evening (QPM) and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg BID + Placebo
Participants received 1 tablet of rilzabrutinib 400 mg orally twice a day (BID) and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg TID
Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
|
OLE Period: Rilzabrutinib 400 mg BID
Participants who completed DB period entered the open-label extension (OLE) period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.
|
OLE Period: Rilzabrutinib 400 mg TID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.
|
|---|---|---|---|---|---|---|
|
Double-Blind Period (Up to 12 Weeks)
STARTED
|
40
|
38
|
41
|
41
|
0
|
0
|
|
Double-Blind Period (Up to 12 Weeks)
COMPLETED
|
37
|
34
|
35
|
36
|
0
|
0
|
|
Double-Blind Period (Up to 12 Weeks)
NOT COMPLETED
|
3
|
4
|
6
|
5
|
0
|
0
|
|
OLE Period (Weeks 13 to 52: 40 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
9
|
128
|
|
OLE Period (Weeks 13 to 52: 40 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
6
|
98
|
|
OLE Period (Weeks 13 to 52: 40 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
30
|
Reasons for withdrawal
| Measure |
DB Period: Placebo TID
Participants received 1 tablet of matching placebo orally TID from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg QPM + Placebo
Participants received 1 tablet of rilzabrutinib 400 milligrams (mg) orally once every evening (QPM) and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg BID + Placebo
Participants received 1 tablet of rilzabrutinib 400 mg orally twice a day (BID) and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg TID
Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
|
OLE Period: Rilzabrutinib 400 mg BID
Participants who completed DB period entered the open-label extension (OLE) period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.
|
OLE Period: Rilzabrutinib 400 mg TID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.
|
|---|---|---|---|---|---|---|
|
Double-Blind Period (Up to 12 Weeks)
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Double-Blind Period (Up to 12 Weeks)
Withdrawal by Subject
|
3
|
2
|
4
|
4
|
0
|
0
|
|
Double-Blind Period (Up to 12 Weeks)
Poor compliance to protocol
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Double-Blind Period (Up to 12 Weeks)
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
0
|
|
OLE Period (Weeks 13 to 52: 40 Weeks)
Other
|
0
|
0
|
0
|
0
|
0
|
3
|
|
OLE Period (Weeks 13 to 52: 40 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
17
|
|
OLE Period (Weeks 13 to 52: 40 Weeks)
Poor compliance to protocol
|
0
|
0
|
0
|
0
|
0
|
1
|
|
OLE Period (Weeks 13 to 52: 40 Weeks)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
2
|
|
OLE Period (Weeks 13 to 52: 40 Weeks)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
7
|
Baseline Characteristics
Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine
Baseline characteristics by cohort
| Measure |
DB Period: Placebo TID
n=40 Participants
Participants received 1 tablet of matching placebo orally TID from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg QPM + Placebo
n=38 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally QPM and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg BID + Placebo
n=41 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally BID and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg TID
n=41 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 14.0 • n=20 Participants
|
42.1 years
STANDARD_DEVIATION 12.7 • n=20 Participants
|
45.5 years
STANDARD_DEVIATION 13.4 • n=40 Participants
|
48.5 years
STANDARD_DEVIATION 12.2 • n=6 Participants
|
44.1 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
33 Participants
n=6 Participants
|
112 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
8 Participants
n=6 Participants
|
48 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
10 Participants
n=6 Participants
|
38 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=20 Participants
|
27 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
30 Participants
n=6 Participants
|
121 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Weekly Urticaria Activity Score (UAS7)
|
30.0 score on a scale
STANDARD_DEVIATION 8.6 • n=20 Participants
|
31.4 score on a scale
STANDARD_DEVIATION 7.3 • n=20 Participants
|
30.2 score on a scale
STANDARD_DEVIATION 7.2 • n=40 Participants
|
29.9 score on a scale
STANDARD_DEVIATION 8.6 • n=6 Participants
|
30.3 score on a scale
STANDARD_DEVIATION 7.9 • n=7 Participants
|
|
Weekly Itch Severity Score (ISS7)
|
15.6 score on a scale
STANDARD_DEVIATION 4.2 • n=20 Participants
|
16.5 score on a scale
STANDARD_DEVIATION 3.5 • n=20 Participants
|
15.8 score on a scale
STANDARD_DEVIATION 3.7 • n=40 Participants
|
15.9 score on a scale
STANDARD_DEVIATION 4.4 • n=6 Participants
|
15.9 score on a scale
STANDARD_DEVIATION 4.0 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Omalizumab-naïve population consisted of all randomized omalizumab-naïve participants. Participants were analyzed according to the study treatment allocated by the randomization. Only participants with data collected at Baseline and Week 12 are reported.
The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease. Baseline is defined as the sum of the 7 days measurements obtained on and prior to the target visit day.
Outcome measures
| Measure |
DB Period: Placebo TID
n=32 Participants
Participants received 1 tablet of matching placebo orally TID from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg QPM + Placebo
n=30 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally QPM and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg BID + Placebo
n=26 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally BID and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg TID
n=28 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
|
OLE Period: Rilzabrutinib 400 mg BID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.
|
OLE Period: Rilzabrutinib 400 mg TID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12
|
-10.14 score on a scale
Standard Deviation 2.05
|
-9.74 score on a scale
Standard Deviation 2.00
|
-14.24 score on a scale
Standard Deviation 2.06
|
-16.89 score on a scale
Standard Deviation 2.04
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Omalizumab-naïve population consisted of all randomized omalizumab-naïve participants. Participants were analyzed according to the study treatment allocated by the randomization. Only participants with data collected at Baseline and Week 12 are reported.
The ISS represents the itch severity on a scale and was recorded by the participant in their e-diary ranging from 0 (None) to 3 (intense). The ISS7 is the sum of ISS for the previous 7 days. The ISS7 represents itch severity on a scale ranging from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of itch. Baseline is defined as the sum of the 7 days measurements obtained on and prior to the target visit day.
Outcome measures
| Measure |
DB Period: Placebo TID
n=32 Participants
Participants received 1 tablet of matching placebo orally TID from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg QPM + Placebo
n=30 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally QPM and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg BID + Placebo
n=26 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally BID and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg TID
n=28 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
|
OLE Period: Rilzabrutinib 400 mg BID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.
|
OLE Period: Rilzabrutinib 400 mg TID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12
|
-5.77 score on a scale
Standard Deviation 1.05
|
-5.19 score on a scale
Standard Deviation 1.02
|
-7.73 score on a scale
Standard Deviation 1.06
|
-9.21 score on a scale
Standard Deviation 1.05
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Omalizumab-naïve population consisted of all randomized omalizumab-naïve participants. Participants were analyzed according to the study treatment allocated by the randomization. Only participants with data collected at Baseline and Week 4 are reported.
The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease. Baseline is defined as the sum of the 7 measurements obtained within the 7 days prior to randomization.
Outcome measures
| Measure |
DB Period: Placebo TID
n=34 Participants
Participants received 1 tablet of matching placebo orally TID from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg QPM + Placebo
n=37 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally QPM and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg BID + Placebo
n=33 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally BID and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg TID
n=32 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
|
OLE Period: Rilzabrutinib 400 mg BID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.
|
OLE Period: Rilzabrutinib 400 mg TID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Weekly Urticaria Activity Score at Week 4
|
-7.06 score on a scale
Standard Error 1.72
|
-9.14 score on a scale
Standard Error 1.66
|
-12.89 score on a scale
Standard Error 1.73
|
-13.66 score on a scale
Standard Error 1.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Omalizumab-naïve population consisted of all randomized omalizumab-naïve participants. Participants were analyzed according to the study treatment allocated by the randomization. Only participants with data collected at Baseline and Week 12 are reported.
The HSS7 represents hive severity score on a scale recorded on e-diary ranging from 0 (None) to 3 (more than 50 hives). A weekly score (HSS7) was sum of the average daily scores of the previous 7 days. The possible range of the weekly score was 0-21 (highest hives activity). Baseline is defined as the sum of the 7 days measurements obtained on and prior to the target visit day.
Outcome measures
| Measure |
DB Period: Placebo TID
n=32 Participants
Participants received 1 tablet of matching placebo orally TID from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg QPM + Placebo
n=30 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally QPM and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg BID + Placebo
n=26 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally BID and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg TID
n=28 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
|
OLE Period: Rilzabrutinib 400 mg BID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.
|
OLE Period: Rilzabrutinib 400 mg TID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12
|
-4.40 score on a scale
Standard Error 1.06
|
-4.49 score on a scale
Standard Error 1.04
|
-6.52 score on a scale
Standard Error 1.07
|
-7.64 score on a scale
Standard Error 1.06
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 12Population: Omalizumab-naïve population consisted of all randomized omalizumab-naïve participants. Participants were analyzed according to the study treatment allocated by the randomization.
The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease. Here, a score ≤6 indicates well-controlled disease.
Outcome measures
| Measure |
DB Period: Placebo TID
n=36 Participants
Participants received 1 tablet of matching placebo orally TID from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg QPM + Placebo
n=37 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally QPM and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg BID + Placebo
n=35 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally BID and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg TID
n=35 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
|
OLE Period: Rilzabrutinib 400 mg BID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.
|
OLE Period: Rilzabrutinib 400 mg TID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Weekly Urticaria Activity Score Less Than or Equal to (≤)6 at Week 12
|
11.1 percentage of participants
|
5.4 percentage of participants
|
20.0 percentage of participants
|
34.3 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 12Population: Omalizumab-naïve population consisted of all randomized omalizumab-naïve participants. Participants were analyzed according to the study treatment allocated by the randomization.
The UAS7 score is a composite score containing both the hive severity score (HSS, ranging from 0 = None to 3 = more than 50 hives) and the itch severity score (ISS, ranging from 0 = None to 3 = intense). The daily UAS scores ranged from 0 to 6 points per day. Daily UAS scores were summed over a 7-day period to create the UAS7, ranging from 0 to 42, and are composed of the HSS7 and ISS7 components. A higher score indicates worse disease. Here, score 0 indicates an absence of both itches and hives and a complete resolution of chronic spontaneous urticaria (CSU) symptoms.
Outcome measures
| Measure |
DB Period: Placebo TID
n=36 Participants
Participants received 1 tablet of matching placebo orally TID from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg QPM + Placebo
n=37 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally QPM and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg BID + Placebo
n=35 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally BID and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg TID
n=35 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
|
OLE Period: Rilzabrutinib 400 mg BID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.
|
OLE Period: Rilzabrutinib 400 mg TID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Weekly Urticaria Activity Score Equal to 0 at Week 12
|
11.1 percentage of participants
|
2.7 percentage of participants
|
14.3 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to last dose of study treatment + 7 days, approximately 13 weeks for DB period and approximately 41 weeks for OLE periodPopulation: Safety population consisted of all randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.
Adverse event (AE): any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of study treatment (on Day 1) to last administration of study treatment + 7 days. SAE: any AE that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event. An AESI was an TEAE (serious or nonserious) of scientific and medical concern specific to Sponsor's product or program.
Outcome measures
| Measure |
DB Period: Placebo TID
n=40 Participants
Participants received 1 tablet of matching placebo orally TID from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg QPM + Placebo
n=38 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally QPM and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg BID + Placebo
n=41 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally BID and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg TID
n=41 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
|
OLE Period: Rilzabrutinib 400 mg BID
n=9 Participants
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.
|
OLE Period: Rilzabrutinib 400 mg TID
n=128 Participants
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (AESIs), and Withdrawals Due to Treatment-Emergent Adverse Events
TEAEs
|
23 Participants
|
23 Participants
|
30 Participants
|
31 Participants
|
7 Participants
|
89 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (AESIs), and Withdrawals Due to Treatment-Emergent Adverse Events
TESAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (AESIs), and Withdrawals Due to Treatment-Emergent Adverse Events
Treatment-Emergent AESIs
|
2 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (AESIs), and Withdrawals Due to Treatment-Emergent Adverse Events
Withdrawals due to TEAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and 2 hours post-dose at Day 1 and Week 4; pre-dose at Week 12 (DB period); pre-dose and 2 hours post-dose at Week 16; pre-dose at Weeks 20, 24 and 52 (OLE period)Population: PK population consisted of safety population without important deviation related to study treatment administration, and with at least 1 post-baseline PK sample with adequate documentation of dosing and sampling dates and times. Participants having received only placebo were not part of the PK population. Participants were analyzed according to the study treatment they actually received. Only participants who received study treatment with data collected at specified timepoints are reported.
Plasma samples were collected at specified timepoints for evaluation of rilzabrutinib pharmacokinetic (PK) concentrations.
Outcome measures
| Measure |
DB Period: Placebo TID
n=36 Participants
Participants received 1 tablet of matching placebo orally TID from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg QPM + Placebo
n=40 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally QPM and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg BID + Placebo
n=39 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally BID and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg TID
n=6 Participants
Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
|
OLE Period: Rilzabrutinib 400 mg BID
n=106 Participants
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.
|
OLE Period: Rilzabrutinib 400 mg TID
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.
|
|---|---|---|---|---|---|---|
|
Plasma Concentration of Rilzabrutinib
Week 20: pre-dose
|
—
|
—
|
—
|
1.97 nanogram per milliliter (ng/mL)
Standard Deviation 0.82
|
34.85 nanogram per milliliter (ng/mL)
Standard Deviation 83.79
|
—
|
|
Plasma Concentration of Rilzabrutinib
Week 24: pre-dose
|
—
|
—
|
—
|
3.31 nanogram per milliliter (ng/mL)
Standard Deviation 1.40
|
16.01 nanogram per milliliter (ng/mL)
Standard Deviation 29.32
|
—
|
|
Plasma Concentration of Rilzabrutinib
Week 52: pre-dose
|
—
|
—
|
—
|
3.51 nanogram per milliliter (ng/mL)
Standard Deviation 1.96
|
20.77 nanogram per milliliter (ng/mL)
Standard Deviation 39.33
|
—
|
|
Plasma Concentration of Rilzabrutinib
Day 1: pre-dose
|
0.00 nanogram per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanogram per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanogram per milliliter (ng/mL)
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Plasma Concentration of Rilzabrutinib
Day 1: 2 hours post-dose
|
1.43 nanogram per milliliter (ng/mL)
Standard Deviation 8.49
|
133.77 nanogram per milliliter (ng/mL)
Standard Deviation 113.67
|
181.16 nanogram per milliliter (ng/mL)
Standard Deviation 139.41
|
—
|
—
|
—
|
|
Plasma Concentration of Rilzabrutinib
Week 4: pre-dose
|
13.83 nanogram per milliliter (ng/mL)
Standard Deviation 26.40
|
26.46 nanogram per milliliter (ng/mL)
Standard Deviation 62.95
|
27.73 nanogram per milliliter (ng/mL)
Standard Deviation 67.72
|
—
|
—
|
—
|
|
Plasma Concentration of Rilzabrutinib
Week 4: 2 hours post-dose
|
5.63 nanogram per milliliter (ng/mL)
Standard Deviation 9.60
|
186.40 nanogram per milliliter (ng/mL)
Standard Deviation 122.19
|
266.13 nanogram per milliliter (ng/mL)
Standard Deviation 232.15
|
—
|
—
|
—
|
|
Plasma Concentration of Rilzabrutinib
Week 12: pre-dose
|
5.68 nanogram per milliliter (ng/mL)
Standard Deviation 7.79
|
11.83 nanogram per milliliter (ng/mL)
Standard Deviation 18.80
|
25.18 nanogram per milliliter (ng/mL)
Standard Deviation 76.01
|
—
|
—
|
—
|
|
Plasma Concentration of Rilzabrutinib
Week 16: pre-dose
|
—
|
—
|
—
|
2.49 nanogram per milliliter (ng/mL)
Standard Deviation 1.66
|
24.90 nanogram per milliliter (ng/mL)
Standard Deviation 44.17
|
—
|
|
Plasma Concentration of Rilzabrutinib
Week 16: 2 hours post-dose
|
—
|
—
|
—
|
153.22 nanogram per milliliter (ng/mL)
Standard Deviation 145.99
|
236.47 nanogram per milliliter (ng/mL)
Standard Deviation 204.47
|
—
|
Adverse Events
DB Period: Placebo TID
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
DB Period: Rilzabrutinib 400 mg QPM + Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
DB Period: Rilzabrutinib 400 mg BID + Placebo
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
DB Period: Rilzabrutinib 400 mg TID
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
OLE Period: Rilzabrutinib 400 mg BID
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
OLE Period: Rilzabrutinib 400 mg TID
Serious events: 4 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB Period: Placebo TID
n=40 participants at risk
Participants received 1 tablet of matching placebo orally TID from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg QPM + Placebo
n=38 participants at risk
Participants received 1 tablet of rilzabrutinib 400 mg orally QPM and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg BID + Placebo
n=41 participants at risk
Participants received 1 tablet of rilzabrutinib 400 mg orally BID and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg TID
n=41 participants at risk
Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
|
OLE Period: Rilzabrutinib 400 mg BID
n=9 participants at risk
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.
|
OLE Period: Rilzabrutinib 400 mg TID
n=128 participants at risk
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Peritonsillar Abscess
|
2.5%
1/40 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/9 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/9 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.78%
1/128 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Immune system disorders
Anaphylactic Shock
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/9 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.78%
1/128 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Eye disorders
Vogt-Koyanagi-Harada Disease
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/9 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.78%
1/128 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.4%
1/41 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/9 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.78%
1/128 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Iatrogenic Injury
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.4%
1/41 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/9 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
Other adverse events
| Measure |
DB Period: Placebo TID
n=40 participants at risk
Participants received 1 tablet of matching placebo orally TID from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg QPM + Placebo
n=38 participants at risk
Participants received 1 tablet of rilzabrutinib 400 mg orally QPM and 2 tablets of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg BID + Placebo
n=41 participants at risk
Participants received 1 tablet of rilzabrutinib 400 mg orally BID and 1 tablet of matching placebo daily from Day 1 to Week 12 during the DB period.
|
DB Period: Rilzabrutinib 400 mg TID
n=41 participants at risk
Participants received 1 tablet of rilzabrutinib 400 mg orally TID from Day 1 to Week 12 during the DB period.
|
OLE Period: Rilzabrutinib 400 mg BID
n=9 participants at risk
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally BID from Week 13 to Week 52.
|
OLE Period: Rilzabrutinib 400 mg TID
n=128 participants at risk
Participants who completed DB period entered the OLE period received 1 tablet of rilzabrutinib 400 mg orally TID from Week 13 to Week 52.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.0%
2/40 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.4%
1/41 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
4.9%
2/41 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
33.3%
3/9 • Number of events 4 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
7.0%
9/128 • Number of events 10 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Infections and infestations
Covid-19
|
5.0%
2/40 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
5.3%
2/38 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
9.8%
4/41 • Number of events 4 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
4.9%
2/41 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
33.3%
3/9 • Number of events 3 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
1.6%
2/128 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.4%
1/41 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.78%
1/128 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.78%
1/128 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.4%
1/41 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
5.3%
2/38 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
14.6%
6/41 • Number of events 7 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
9.8%
4/41 • Number of events 5 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/9 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
5.5%
7/128 • Number of events 8 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Nervous system disorders
Sciatica
|
2.5%
1/40 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.78%
1/128 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Eye disorders
Presbyopia
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
4.9%
2/41 • Number of events 3 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
5.3%
2/38 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/9 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.0%
2/40 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 4 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
12.2%
5/41 • Number of events 5 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 4 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
3.9%
5/128 • Number of events 5 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.4%
1/41 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.4%
1/41 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
1.6%
2/128 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
6/40 • Number of events 6 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
7.9%
3/38 • Number of events 3 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
29.3%
12/41 • Number of events 14 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
29.3%
12/41 • Number of events 14 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 5 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
14.8%
19/128 • Number of events 24 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
1/40 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
5.3%
2/38 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.4%
1/41 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.4%
1/41 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.78%
1/128 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.4%
1/41 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
1.6%
2/128 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
2/40 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
13.2%
5/38 • Number of events 5 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
17.1%
7/41 • Number of events 7 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
19.5%
8/41 • Number of events 8 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
13.3%
17/128 • Number of events 19 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Chronic Spontaneous Urticaria
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
7.9%
3/38 • Number of events 4 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.78%
1/128 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.5%
3/40 • Number of events 3 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
7.9%
3/38 • Number of events 3 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
7.3%
3/41 • Number of events 4 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.4%
1/41 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/9 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
5.5%
7/128 • Number of events 8 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
7.3%
3/41 • Number of events 3 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.4%
1/41 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
3.9%
5/128 • Number of events 7 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 3 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Abnormal Uterine Bleeding
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 5 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/128 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
2.5%
1/40 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.6%
1/38 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.4%
1/41 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
4.9%
2/41 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.78%
1/128 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/38 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/41 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
11.1%
1/9 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.78%
1/128 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/40 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
5.3%
2/38 • Number of events 2 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
2.4%
1/41 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
7.3%
3/41 • Number of events 3 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.00%
0/9 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
0.78%
1/128 • Number of events 1 • Adverse events data were collected from first dose of study treatment (Day 1) up to last dose of study treatment + 7 days approximately 13 weeks for DB period and approximately 41 weeks for OLE period. All-cause mortality (death) was assessed from the signing of the ICF up to approximately 125 weeks.
Analysis was performed on safety population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data
- Publication restrictions are in place
Restriction type: OTHER