Trial Outcomes & Findings for Open-Label Study of AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a in Subjects With Chronic Hepatitis B Infection (NCT NCT04980482)
NCT ID: NCT04980482
Last Updated: 2026-04-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Up to 124 weeks
Results posted on
2026-04-29
Participant Flow
A total of 43 virally suppressed, HBeAg-negative CHB subjects were randomized across 4 cohorts (Cohort A1, N = 12; Cohort A2, N = 13; Cohort B1, N = 8; Cohort B2, N = 10).
24 week lead-in period of imdusiran 60 mg SC every 8 weeks (Q8W) x4 doses added to ongoing SOC NA therapy
Participant milestones
| Measure |
Lead-In Treatment
24 week lead-in period of imdusiran 60 mg SC every 8 weeks (Q8W) x4 doses added to ongoing SOC NA therapy
|
Cohort A1
AB-729 60 mg SC every 8 weeks x2 doses + NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
|
Cohort A2
NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
|
Cohort B1
AB-729 60 mg SC every 8 weeks, x1 dose + NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.
|
Cohort B2
NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.
|
|---|---|---|---|---|---|
|
Lead-In Treatment
STARTED
|
43
|
0
|
0
|
0
|
0
|
|
Lead-In Treatment
COMPLETED
|
43
|
0
|
0
|
0
|
0
|
|
Lead-In Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Consolidation Treatment
STARTED
|
0
|
12
|
13
|
8
|
10
|
|
Consolidation Treatment
COMPLETED
|
0
|
12
|
13
|
8
|
10
|
|
Consolidation Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
NA Only (Before NA Discontinuation)
STARTED
|
0
|
12
|
13
|
8
|
10
|
|
NA Only (Before NA Discontinuation)
COMPLETED
|
0
|
12
|
13
|
8
|
10
|
|
NA Only (Before NA Discontinuation)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
NA Discontinuation/Did Not Discontinue
STARTED
|
0
|
12
|
13
|
8
|
10
|
|
NA Discontinuation/Did Not Discontinue
NA Discontinuation
|
0
|
9
|
3
|
4
|
5
|
|
NA Discontinuation/Did Not Discontinue
NA Did Not Discontinue
|
0
|
3
|
10
|
4
|
5
|
|
NA Discontinuation/Did Not Discontinue
COMPLETED
|
0
|
12
|
13
|
8
|
9
|
|
NA Discontinuation/Did Not Discontinue
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Study of AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a in Subjects With Chronic Hepatitis B Infection
Baseline characteristics by cohort
| Measure |
Cohort A1
n=12 Participants
AB-729 60 mg SC every 8 weeks, x2 doses + NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
|
Cohort A2
n=13 Participants
NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
|
Cohort B1
n=8 Participants
AB-729 60 mg SC every 8 weeks, x1 dose + NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.
|
Cohort B2
n=10 Participants
NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.5 Years
n=9 Participants
|
41.5 Years
n=24 Participants
|
48.6 Years
n=23 Participants
|
47.2 Years
n=73 Participants
|
45.3 Years
n=451 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=23 Participants
|
3 Participants
n=73 Participants
|
12 Participants
n=451 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
12 Participants
n=24 Participants
|
6 Participants
n=23 Participants
|
7 Participants
n=73 Participants
|
31 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=9 Participants
|
9 Participants
n=24 Participants
|
7 Participants
n=23 Participants
|
8 Participants
n=73 Participants
|
34 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=9 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=73 Participants
|
7 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
1 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
12 Participants
n=9 Participants
|
12 Participants
n=24 Participants
|
8 Participants
n=23 Participants
|
10 Participants
n=73 Participants
|
42 Participants
n=451 Participants
|
|
Race/Ethnicity, Customized
Not Reported/Unknown
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=73 Participants
|
0 Participants
n=451 Participants
|
|
Weight (kg)
|
64.52 kg
STANDARD_DEVIATION 15.764 • n=9 Participants
|
79.45 kg
STANDARD_DEVIATION 16.653 • n=24 Participants
|
74.15 kg
STANDARD_DEVIATION 7.421 • n=23 Participants
|
75.40 kg
STANDARD_DEVIATION 23.890 • n=73 Participants
|
73.36 kg
STANDARD_DEVIATION 17.627 • n=451 Participants
|
|
Height (cm)
|
164.64 cm
STANDARD_DEVIATION 9.690 • n=9 Participants
|
170.78 cm
STANDARD_DEVIATION 6.164 • n=24 Participants
|
166.88 cm
STANDARD_DEVIATION 6.365 • n=23 Participants
|
169.70 cm
STANDARD_DEVIATION 9.965 • n=73 Participants
|
168.09 cm
STANDARD_DEVIATION 8.368 • n=451 Participants
|
|
Body Mass Index (kg/m2)
|
23.59 kg/m2
STANDARD_DEVIATION 4.360 • n=9 Participants
|
27.10 kg/m2
STANDARD_DEVIATION 4.739 • n=24 Participants
|
26.61 kg/m2
STANDARD_DEVIATION 2.344 • n=23 Participants
|
25.79 kg/m2
STANDARD_DEVIATION 6.513 • n=73 Participants
|
25.73 kg/m2
STANDARD_DEVIATION 4.841 • n=451 Participants
|
|
Baseline ALT (U/L)
|
19.2 U/L
STANDARD_DEVIATION 6.07 • n=9 Participants
|
25.3 U/L
STANDARD_DEVIATION 9.81 • n=24 Participants
|
30.0 U/L
STANDARD_DEVIATION 13.24 • n=23 Participants
|
25.8 U/L
STANDARD_DEVIATION 10.99 • n=73 Participants
|
24.6 U/L
STANDARD_DEVIATION 10.33 • n=451 Participants
|
|
Baseline HBsAg (Log10 IU/mL)
|
3.020 Log10 IU/mL
STANDARD_DEVIATION 0.4499 • n=9 Participants
|
2.914 Log10 IU/mL
STANDARD_DEVIATION 0.5156 • n=24 Participants
|
2.944 Log10 IU/mL
STANDARD_DEVIATION 0.3361 • n=23 Participants
|
3.059 Log10 IU/mL
STANDARD_DEVIATION 0.5920 • n=73 Participants
|
2.983 Log10 IU/mL
STANDARD_DEVIATION 0.4759 • n=451 Participants
|
|
Baseline HBV DNA (IU/mL)
|
2.3 IU/mL
STANDARD_DEVIATION 1.97 • n=9 Participants
|
1.3 IU/mL
STANDARD_DEVIATION 1.11 • n=24 Participants
|
2.0 IU/mL
STANDARD_DEVIATION 1.85 • n=23 Participants
|
1.0 IU/mL
STANDARD_DEVIATION 0.00 • n=73 Participants
|
1.7 IU/mL
STANDARD_DEVIATION 1.49 • n=451 Participants
|
|
Background Nucleos(t)ide Analog
Tenofovir disoproxil fumarate
|
5 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=23 Participants
|
5 Participants
n=73 Participants
|
14 Participants
n=451 Participants
|
|
Background Nucleos(t)ide Analog
Tenofovir alafenamide
|
5 Participants
n=9 Participants
|
7 Participants
n=24 Participants
|
2 Participants
n=23 Participants
|
2 Participants
n=73 Participants
|
16 Participants
n=451 Participants
|
|
Background Nucleos(t)ide Analog
Entecavir
|
2 Participants
n=9 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
3 Participants
n=73 Participants
|
13 Participants
n=451 Participants
|
PRIMARY outcome
Timeframe: Up to 124 weeksPopulation: Safety Lead-in Population
Outcome measures
| Measure |
Lead-In Treatment
n=43 Participants
24 week lead-in period of imdusiran 60 mg SC every 8 weeks (Q8W) x4 doses added to ongoing SOC NA therapy
|
Cohort A1
n=12 Participants
AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to:
AB-729 60 mg SC every 8 weeks + NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
|
Cohort A2
n=13 Participants
AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to:
NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
|
Cohort B1
n=8 Participants
AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to:
AB-729 60 mg SC every 8 weeks + NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.
|
Cohort B2
n=10 Participants
AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to:
NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.
|
|---|---|---|---|---|---|
|
The Frequency and Severity of Treatment Emergent Adverse Events (TEAEs), Discontinuations Due to AEs and Lab Abnormalities After Dosing With AB-729 Plus Peg-IFNα-2a
Grade 3 or higher treatment emergent laboratory abnormality · TEAEs
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
The Frequency and Severity of Treatment Emergent Adverse Events (TEAEs), Discontinuations Due to AEs and Lab Abnormalities After Dosing With AB-729 Plus Peg-IFNα-2a
Frequency of TEAEs · TEAEs
|
23 Participants
|
11 Participants
|
11 Participants
|
8 Participants
|
9 Participants
|
|
The Frequency and Severity of Treatment Emergent Adverse Events (TEAEs), Discontinuations Due to AEs and Lab Abnormalities After Dosing With AB-729 Plus Peg-IFNα-2a
Discontinuation due to AEs · TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 124 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 124 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 76 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 124 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 124 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 40 weeksOutcome measures
Outcome data not reported
Adverse Events
Lead-In Treatment
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Cohort A1
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort A2
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort B1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort B2
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lead-In Treatment
n=43 participants at risk
24 week lead-in period of imdusiran 60 mg SC every 8 weeks (Q8W) x4 doses added to ongoing SOC NA therapy
|
Cohort A1
n=12 participants at risk
AB-729 60 mg SC every 8 weeks, x2 doses + NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
|
Cohort A2
n=13 participants at risk
NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
|
Cohort B1
n=8 participants at risk
AB-729 60 mg SC every 8 weeks, x1 dose + NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.
|
Cohort B2
n=10 participants at risk
NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral Chronic Rhinonasal Sinusitis with Polyposis
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Septum Deviation
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
Other adverse events
| Measure |
Lead-In Treatment
n=43 participants at risk
24 week lead-in period of imdusiran 60 mg SC every 8 weeks (Q8W) x4 doses added to ongoing SOC NA therapy
|
Cohort A1
n=12 participants at risk
AB-729 60 mg SC every 8 weeks, x2 doses + NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
|
Cohort A2
n=13 participants at risk
NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
|
Cohort B1
n=8 participants at risk
AB-729 60 mg SC every 8 weeks, x1 dose + NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.
|
Cohort B2
n=10 participants at risk
NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.
|
|---|---|---|---|---|---|
|
General disorders
Chills
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
16.7%
2/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Injection Site Bruising
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Injection Site Pain
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
16.7%
2/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Injection Site Reaction
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Chest Pain
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Injection Site Discoloration
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Injection Site Irritation
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Injection Site Pruritus
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Mucosal Dryness
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Pain
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Swelling
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Thirst
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
12.5%
1/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Infections and infestations
COVID-19
|
11.6%
5/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
12.5%
1/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.3%
4/43 • 124 weeks
AEs collected from randomization through week 124
|
16.7%
2/12 • 124 weeks
AEs collected from randomization through week 124
|
15.4%
2/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
16.7%
2/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Infections and infestations
Urinary Tract Infection
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Infections and infestations
Gingivitis
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Infections and infestations
Laryngitis
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Gastrointestinal disorders
Peptic Ulcer
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Gastrointestinal disorders
Tooth Impacted
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Pyrexia
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
41.7%
5/12 • 124 weeks
AEs collected from randomization through week 124
|
15.4%
2/13 • 124 weeks
AEs collected from randomization through week 124
|
25.0%
2/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Injection Site Erythema
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
33.3%
4/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Fatigue
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
16.7%
2/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
General disorders
Influenza like illness
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Investigations
Alanine Aminotransferase Increased
|
7.0%
3/43 • 124 weeks
AEs collected from randomization through week 124
|
25.0%
3/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
37.5%
3/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
16.7%
2/12 • 124 weeks
AEs collected from randomization through week 124
|
23.1%
3/13 • 124 weeks
AEs collected from randomization through week 124
|
12.5%
1/8 • 124 weeks
AEs collected from randomization through week 124
|
20.0%
2/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
16.7%
2/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
12.5%
1/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Investigations
Sar-Cov-2 Test Positive
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
12.5%
1/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Investigations
Weight Decreased
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Investigations
Blood Thyroid Stimulating Hormone Increased
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Investigations
Liver Function Test Increased
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
12.5%
1/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Investigations
Transaminase Increased
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
12.5%
1/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
12.5%
1/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Infections and infestations
Pelvic Inflammatory Disease
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Nervous system disorders
Headache
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
16.7%
2/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
25.0%
2/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Psychiatric disorders
Depression
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
15.4%
2/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Renal and urinary disorders
Ureterolithiasis
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
16.7%
2/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar Cyst
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
25.0%
3/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
16.7%
2/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
2/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Nervous system disorders
Dizziness
|
4.7%
2/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Psychiatric disorders
Anxiety Disorder
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Skin Swelling
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Renal and urinary disorders
Renal Cyst
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Hand Dermatitis
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
12.5%
1/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Non-Scarring Alopecia
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Palmer Erythema
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Surgical and medical procedures
Endodontic Procedure
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Vascular disorders
Varicose Vein
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Gastrointestinal disorders
Dental Caries
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Infections and infestations
Abcess
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Infections and infestations
Sinusitis
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Rhinosinusitis with Nasal Polyps
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Septum Deviation
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
16.7%
2/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.3%
1/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
8.3%
1/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Blood and lymphatic system disorders
Iron Deficiency Anemia
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
10.0%
1/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/43 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/12 • 124 weeks
AEs collected from randomization through week 124
|
7.7%
1/13 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/8 • 124 weeks
AEs collected from randomization through week 124
|
0.00%
0/10 • 124 weeks
AEs collected from randomization through week 124
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place