Trial Outcomes & Findings for A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis (NCT NCT03831191)
NCT ID: NCT03831191
Last Updated: 2021-04-20
Results Overview
vIGA-AD measures participants' overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity.The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
136 participants
Primary outcome timeframe
Week 16
Results posted on
2021-04-20
Participant Flow
Responders are participants who achieved a 50% reduction in the Eczema Area and Severity Index score \[EASI-50\] response, regardless of whether rescue therapy had been initiated during induction period. Participants did not receive 300 mg because the trial was stopped early.
Participant milestones
| Measure |
Placebo
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
|
50 mg LY3375880
Induction Period:
Participants received 50 milligrams (mg) LY3375880 administered SC Q4W.
|
150 mg LY3375880
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
|
Placebo Responder to Placebo/300 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 300 mg LY3375880 SC Q4W .
Participants had received placebo SC Q4W during the induction period.
|
Placebo Non-Responder to 300 mg LY3375880
Maintenance Period:
Participants received 300 mg LY3375880 administered SC Q4W.
Participants had received placebo SC Q4W during the induction period.
|
50 mg Responder to Placebo/50 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 50 mg LY3375880 SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
|
50 mg LY3375880 Responder to 50 mg LY3375880
Maintenance Period:
Participants received 50 mg LY3375880 administered SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
|
50 mg LY3375880 Non-Responder to 150 mg LY3375880
Maintenance Period:
Participants received 150 mg LY3375880 administered SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
|
150 mg Responder to Placebo/150 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 150 mg LY3375880 SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
|
150 mg LY3375880 Responder to 150 mg LY3375880
Maintenance Period:
Participants received 150 mg LY3375880 administered SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
|
150 mg LY3375880 Non-Responder to 300 mg LY3375880
Maintenance Period:
Participants received 300 mg LY3375880 administered SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
|
600 mg Responder to Placebo/600 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 600 mg LY3375880 SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
|
600 mg LY3375880 Responder to 600 mg LY3375880
Maintenance Period:
Participants received 600 mg LY3375880 administered SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
|
600 mg LY3375880 Non-Responder to 600 mg LY3375880
Maintenance Period:
Participants received 600 mg LY3375880 administered SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Period (16 Weeks)
STARTED
|
33
|
35
|
34
|
34
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (16 Weeks)
Received at Least One Dose of Study Drug
|
33
|
35
|
34
|
33
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (16 Weeks)
COMPLETED
|
10
|
14
|
13
|
11
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (16 Weeks)
NOT COMPLETED
|
23
|
21
|
21
|
23
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (36 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
4
|
5
|
2
|
4
|
8
|
1
|
4
|
8
|
1
|
1
|
9
|
|
Maintenance Period (36 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Period (36 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
4
|
5
|
2
|
4
|
8
|
1
|
4
|
7
|
1
|
1
|
9
|
|
Post-Treatment Follow-Up Period(8 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Post-Treatment Follow-Up Period(8 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Post-Treatment Follow-Up Period(8 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
|
50 mg LY3375880
Induction Period:
Participants received 50 milligrams (mg) LY3375880 administered SC Q4W.
|
150 mg LY3375880
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
|
Placebo Responder to Placebo/300 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 300 mg LY3375880 SC Q4W .
Participants had received placebo SC Q4W during the induction period.
|
Placebo Non-Responder to 300 mg LY3375880
Maintenance Period:
Participants received 300 mg LY3375880 administered SC Q4W.
Participants had received placebo SC Q4W during the induction period.
|
50 mg Responder to Placebo/50 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 50 mg LY3375880 SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
|
50 mg LY3375880 Responder to 50 mg LY3375880
Maintenance Period:
Participants received 50 mg LY3375880 administered SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
|
50 mg LY3375880 Non-Responder to 150 mg LY3375880
Maintenance Period:
Participants received 150 mg LY3375880 administered SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
|
150 mg Responder to Placebo/150 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 150 mg LY3375880 SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
|
150 mg LY3375880 Responder to 150 mg LY3375880
Maintenance Period:
Participants received 150 mg LY3375880 administered SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
|
150 mg LY3375880 Non-Responder to 300 mg LY3375880
Maintenance Period:
Participants received 300 mg LY3375880 administered SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
|
600 mg Responder to Placebo/600 mg LY3375880
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 600 mg LY3375880 SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
|
600 mg LY3375880 Responder to 600 mg LY3375880
Maintenance Period:
Participants received 600 mg LY3375880 administered SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
|
600 mg LY3375880 Non-Responder to 600 mg LY3375880
Maintenance Period:
Participants received 600 mg LY3375880 administered SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Period (16 Weeks)
Adverse Event
|
2
|
1
|
3
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (16 Weeks)
Lack of Efficacy
|
2
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (16 Weeks)
Pregnancy
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (16 Weeks)
Protocol Violation
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (16 Weeks)
Withdrawal by Subject
|
7
|
2
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (16 Weeks)
Study Terminated by Sponsor
|
12
|
15
|
16
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (16 Weeks)
Sponsor Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (36 Weeks)
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
4
|
5
|
2
|
4
|
8
|
1
|
4
|
7
|
1
|
1
|
6
|
|
Maintenance Period (36 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Maintenance Period (36 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=33 Participants
Induction Period:
Participants received placebo administered SC Q4W.
|
50 mg LY3375880
n=35 Participants
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
|
150 mg LY3375880
n=34 Participants
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
n=34 Participants
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.00 years
STANDARD_DEVIATION 14.98 • n=5 Participants
|
37.70 years
STANDARD_DEVIATION 16.00 • n=7 Participants
|
39.50 years
STANDARD_DEVIATION 13.94 • n=5 Participants
|
36.80 years
STANDARD_DEVIATION 13.84 • n=4 Participants
|
37.80 years
STANDARD_DEVIATION 14.60 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
Argentina
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.
vIGA-AD measures participants' overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity.The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.
Outcome measures
| Measure |
Placebo
n=21 Participants
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
|
50 mg LY3375880
n=20 Participants
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
|
150 mg LY3375880
n=17 Participants
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
n=21 Participants
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
Participants received 600 mg LY3375880 administered SC Q4W.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (vIGA-AD) of 0 or 1 With a ≥2 Point Improvement
|
9.5 Percentage of participants
Interval 2.7 to 28.9
|
5.0 Percentage of participants
Interval 0.9 to 23.6
|
5.9 Percentage of participants
Interval 1.0 to 27.0
|
4.8 Percentage of participants
Interval 0.8 to 22.7
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.
EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs - by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. Each body site will have a score that ranges from 0 to 72, and the final EASI score will be obtained by weight-averaging these 4 scores. Hence, the final EASI score will range from 0 to 72 (severe) for each time point. A higher score represented greater disease severity.The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. Non-responder imputation (NRI) method was used to impute missing data.
Outcome measures
| Measure |
Placebo
n=21 Participants
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
|
50 mg LY3375880
n=20 Participants
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
|
150 mg LY3375880
n=17 Participants
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
n=21 Participants
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
Participants received 600 mg LY3375880 administered SC Q4W.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)
|
19.0 Percentage of Participants
Interval 7.7 to 40.0
|
15.0 Percentage of Participants
Interval 5.2 to 36.0
|
23.5 Percentage of Participants
Interval 9.6 to 47.3
|
0.0 Percentage of Participants
Interval 0.0 to 15.5
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.
The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; and genitals 1%). It evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales (VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss. These 3 aspects: extent of disease, disease severity, and subjective symptoms combine to give a score between 0(no disease) and 103 (severe disease). Higher scores indicate greater severity.Non-responder imputation (NRI) method was used to impute missing data.
Outcome measures
| Measure |
Placebo
n=21 Participants
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
|
50 mg LY3375880
n=20 Participants
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
|
150 mg LY3375880
n=17 Participants
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
n=21 Participants
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
Participants received 600 mg LY3375880 administered SC Q4W.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75)
|
4.8 Percentage of participants
Interval 0.8 to 22.7
|
5.0 Percentage of participants
Interval 0.9 to 23.6
|
0.0 Percentage of participants
Interval 0.0 to 18.4
|
0.0 Percentage of participants
Interval 0.0 to 15.5
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.
vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.
Outcome measures
| Measure |
Placebo
n=21 Participants
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
|
50 mg LY3375880
n=20 Participants
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
|
150 mg LY3375880
n=17 Participants
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
n=21 Participants
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
Participants received 600 mg LY3375880 administered SC Q4W.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving vIGA-AD of 0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Induction Period: All randomized participants who had a baseline and at least one post-baseline EASI value.
EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis-disease extent and clinical signs-by scoring the extent of disease(percentage of skin affected: 0= 0%;1 =1-9%; 2 =10-29%;3 = 30-49%;4 = 50-69%;5 = 70-89%;6 = 90-100%) and the severity of 4 clinical signs (erythema,edema/papulation,excoriation,and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 =mild; 2 = moderate; 3=severe) at 4 body sites(head and neck,trunk,upper limbs,and lower limbs).Half scores are allowed.Each body site will have a score that ranges from 0 to 72,and the final EASI score will be obtained by weight-averaging these 4 scores.Hence,the final EASI score will range from 0 to 72(severe) for each time point.Higher scores indicate greater severity.Least Squares Mean(LS Means) were calculated using mixed model repeated measures(MMRM) with treatment,region, baseline disease severity,visit,treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.
Outcome measures
| Measure |
Placebo
n=6 Participants
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
|
50 mg LY3375880
n=8 Participants
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
|
150 mg LY3375880
n=8 Participants
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
n=9 Participants
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
Participants received 600 mg LY3375880 administered SC Q4W.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
|
-11.45 score on a scale
Standard Error 4.68
|
-4.90 score on a scale
Standard Error 4.30
|
-5.89 score on a scale
Standard Error 4.55
|
-7.87 score on a scale
Standard Error 4.02
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Induction Period: All randomized participants who had a baseline and at least one post-baseline SCORAD value.
The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%;upper limbs 9% each;lower limbs 18% each;anterior trunk 18%;back 18%;and genitals 1%).It evaluates 6 clinical characteristics to determine disease severity: (1)erythema,(2)edema/papulation, (3)oozing/crusts,(4) excoriation,(5) lichenification, and (6) dryness on a scale of 0 to 3(0=absence,1=mild,2=moderate,3=severe).The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales(VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss.These 3 aspects: extent of disease,disease severity,and subjective symptoms combine to give a score between 0(no disease) and 103(severe disease).Higher scores indicate greater severity. LS Means were calculated using a MMRM model with treatment,region,baseline disease severity,visit, treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.
Outcome measures
| Measure |
Placebo
n=7 Participants
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
|
50 mg LY3375880
n=8 Participants
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
|
150 mg LY3375880
n=8 Participants
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
n=9 Participants
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
Participants received 600 mg LY3375880 administered SC Q4W.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in SCORAD
|
-19.27 score on a scale
Standard Error 5.92
|
-11.66 score on a scale
Standard Error 5.72
|
-16.94 score on a scale
Standard Error 6.03
|
-12.75 score on a scale
Standard Error 5.3
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Maintenance Period: All randomized participants who had a \>=2-point improvement at Week 52.
vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.
Outcome measures
| Measure |
Placebo
n=8 Participants
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
|
50 mg LY3375880
n=4 Participants
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
|
150 mg LY3375880
n=12 Participants
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
n=13 Participants
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
n=10 Participants
Participants received 600 mg LY3375880 administered SC Q4W.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving vIGA-AD of 0 or 1 With a >=2-point Improvement at Week 52
|
0.0 Percentage of participants
Interval 0.0 to 32.4
|
0.0 Percentage of participants
Interval 0.0 to 49.0
|
0.0 Percentage of participants
Interval 0.0 to 24.2
|
0.0 Percentage of participants
Interval 0.0 to 22.8
|
0.0 Percentage of participants
Interval 0.0 to 27.8
|
SECONDARY outcome
Timeframe: Induction Period: Pre-dose, Day 0, Day 7, Day 14, Day 28, Day 56, Day 112 Post-dose; Maintenance Period:Predose, Day 168; Day 252, Day 364 Post-dosePopulation: All randomized participants who received LY3375880 in induction and maintenance period who had evaluable PK data. Participants did not received 300 mg because the trial was stopped early.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a steady state (AUCτ,ss) of LY3375880. The PK model was fit using all quantifiable concentrations that were collected in the study (i.e., from the induction and maintenance periods).
Outcome measures
| Measure |
Placebo
n=35 Participants
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
|
50 mg LY3375880
n=34 Participants
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
|
150 mg LY3375880
n=33 Participants
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
Participants received 600 mg LY3375880 administered SC Q4W.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Steady State (AUCτ,ss) of LY3375880
|
4450 Nanograms*hour per millilitre (ng*h/mL)
Geometric Coefficient of Variation 80.2
|
11200 Nanograms*hour per millilitre (ng*h/mL)
Geometric Coefficient of Variation 41.9
|
49000 Nanograms*hour per millilitre (ng*h/mL)
Geometric Coefficient of Variation 40.5
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
50 mg LY3375880
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
150 mg LY3375880
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
600 mg LY3375880
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo Responder to Placebo/300 mg LY3375880
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Non-Responder to 300 mg LY3375880
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
50 mg Responder to Placebo/50 mg LY3375880
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
50 mg LY3375880 Responder to 50 mg LY3375880
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
50 mg LY3375880 Non-Responder to 150 mg LY3375880
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
150 mg Responder to Placebo/150 mg LY3375880
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
150 mg LY3375880 Responder to 150 mg LY3375880
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
150 mg LY3375880 Non-Responder to 300 mg LY3375880
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
600 mg Responder to Placebo/600 mg LY3375880
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
600 mg LY3375880 Responder to 600 mg LY3375880
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
600 mg LY3375880 Non-Responder to 600 mg LY3375880
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LY3375880-50mg-Q4W-Post-Treatment Follow-Up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LY3375880-150mg-Q4W-Post-Treatment Follow-Up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LY3375880-600mg-Q4W-Post-Treatment Follow-Up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo-Post-Treatment Follow-Up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=33 participants at risk
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
|
50 mg LY3375880
n=35 participants at risk
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
|
150 mg LY3375880
n=34 participants at risk
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
n=33 participants at risk
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
|
Placebo Responder to Placebo/300 mg LY3375880
n=4 participants at risk
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 300 mg LY3375880 SC Q4W .
Participants had received placebo SC Q4W during the induction period.
|
Placebo Non-Responder to 300 mg LY3375880
n=5 participants at risk
Maintenance Period:
Participants received 300 mg LY3375880 administered SC Q4W.
Participants had received placebo SC Q4W during the induction period.
|
50 mg Responder to Placebo/50 mg LY3375880
n=2 participants at risk
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 50 mg LY3375880 SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
|
50 mg LY3375880 Responder to 50 mg LY3375880
n=4 participants at risk
Maintenance Period:
Participants received 50 mg LY3375880 administered SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
|
50 mg LY3375880 Non-Responder to 150 mg LY3375880
n=8 participants at risk
Maintenance Period:
Participants received 150 mg LY3375880 administered SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
|
150 mg Responder to Placebo/150 mg LY3375880
n=1 participants at risk
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 150 mg LY3375880 SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
|
150 mg LY3375880 Responder to 150 mg LY3375880
n=4 participants at risk
Maintenance Period:
Participants received 150 mg LY3375880 administered SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
|
150 mg LY3375880 Non-Responder to 300 mg LY3375880
n=8 participants at risk
Maintenance Period:
Participants received 300 mg LY3375880 administered SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
|
600 mg Responder to Placebo/600 mg LY3375880
n=1 participants at risk
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 600 mg LY3375880 SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
|
600 mg LY3375880 Responder to 600 mg LY3375880
n=1 participants at risk
Maintenance Period:
Participants received 600 mg LY3375880 administered SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
|
600 mg LY3375880 Non-Responder to 600 mg LY3375880
n=9 participants at risk
Maintenance Period:
Participants received 600 mg LY3375880 administered SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
|
LY3375880-50mg-Q4W-Post-Treatment Follow-Up Period
Follow-up: participants did not receive drug during the follow-up period.
|
LY3375880-150mg-Q4W-Post-Treatment Follow-Up Period
Follow-up: participants did not receive drug during the follow-up period.
|
LY3375880-600mg-Q4W-Post-Treatment Follow-Up Period
Follow-up: participants did not receive drug during the follow-up period.
|
Placebo-Post-Treatment Follow-Up Period
Follow-up: participants did not receive drug during the follow-up period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
20.0%
1/5 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Cellulitis
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.0%
1/33 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.0%
1/33 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
Other adverse events
| Measure |
Placebo
n=33 participants at risk
Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
|
50 mg LY3375880
n=35 participants at risk
Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
|
150 mg LY3375880
n=34 participants at risk
Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
|
600 mg LY3375880
n=33 participants at risk
Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
|
Placebo Responder to Placebo/300 mg LY3375880
n=4 participants at risk
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 300 mg LY3375880 SC Q4W .
Participants had received placebo SC Q4W during the induction period.
|
Placebo Non-Responder to 300 mg LY3375880
n=5 participants at risk
Maintenance Period:
Participants received 300 mg LY3375880 administered SC Q4W.
Participants had received placebo SC Q4W during the induction period.
|
50 mg Responder to Placebo/50 mg LY3375880
n=2 participants at risk
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 50 mg LY3375880 SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
|
50 mg LY3375880 Responder to 50 mg LY3375880
n=4 participants at risk
Maintenance Period:
Participants received 50 mg LY3375880 administered SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
|
50 mg LY3375880 Non-Responder to 150 mg LY3375880
n=8 participants at risk
Maintenance Period:
Participants received 150 mg LY3375880 administered SC Q4W.
Participants had received 50 mg LY3375880 SC Q4W during the induction period.
|
150 mg Responder to Placebo/150 mg LY3375880
n=1 participants at risk
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 150 mg LY3375880 SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
|
150 mg LY3375880 Responder to 150 mg LY3375880
n=4 participants at risk
Maintenance Period:
Participants received 150 mg LY3375880 administered SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
|
150 mg LY3375880 Non-Responder to 300 mg LY3375880
n=8 participants at risk
Maintenance Period:
Participants received 300 mg LY3375880 administered SC Q4W.
Participants had received 150 mg LY3375880 SC Q4W during the induction period.
|
600 mg Responder to Placebo/600 mg LY3375880
n=1 participants at risk
Maintenance Period:
Participants received placebo administered SC Q4W until loss of response then 600 mg LY3375880 SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
|
600 mg LY3375880 Responder to 600 mg LY3375880
n=1 participants at risk
Maintenance Period:
Participants received 600 mg LY3375880 administered SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
|
600 mg LY3375880 Non-Responder to 600 mg LY3375880
n=9 participants at risk
Maintenance Period:
Participants received 600 mg LY3375880 administered SC Q4W.
Participants had received 600 mg LY3375880 SC Q4W during the induction period.
|
LY3375880-50mg-Q4W-Post-Treatment Follow-Up Period
Follow-up: participants did not receive drug during the follow-up period.
|
LY3375880-150mg-Q4W-Post-Treatment Follow-Up Period
Follow-up: participants did not receive drug during the follow-up period.
|
LY3375880-600mg-Q4W-Post-Treatment Follow-Up Period
Follow-up: participants did not receive drug during the follow-up period.
|
Placebo-Post-Treatment Follow-Up Period
Follow-up: participants did not receive drug during the follow-up period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
3.0%
1/33 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
5.7%
2/35 • Number of events 2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
6.1%
2/33 • Number of events 2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
12.5%
1/8 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
11.1%
1/9 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
20.0%
1/5 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
20.0%
1/5 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Eye disorders
Cataract
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.0%
1/33 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
11.1%
1/9 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
20.0%
1/5 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Injection site pain
|
3.0%
1/33 • Number of events 6 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
6.1%
2/33 • Number of events 4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
General disorders
Injection site reaction
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.9%
1/34 • Number of events 2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
25.0%
1/4 • Number of events 4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Cellulitis
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
20.0%
1/5 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Folliculitis
|
3.0%
1/33 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.9%
1/35 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
12.5%
1/8 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
8.6%
3/35 • Number of events 3 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.9%
1/34 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
20.0%
1/5 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
12.5%
1/8 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Paronychia
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
5.9%
2/34 • Number of events 2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Postoperative wound infection
|
3.0%
1/33 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.9%
1/35 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
8.8%
3/34 • Number of events 4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.0%
1/33 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
100.0%
1/1 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.9%
1/34 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.0%
1/33 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
50.0%
1/2 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
12.5%
1/8 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
11.1%
1/9 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
11.1%
1/9 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.0%
1/33 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
20.0%
1/5 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
6.1%
2/33 • Number of events 2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
20.0%
1/5 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
20.0%
1/5 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
6.1%
2/33 • Number of events 2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Psychiatric disorders
Depression
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.9%
1/35 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
12.5%
1/8 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Psychiatric disorders
Insomnia
|
6.1%
2/33 • Number of events 2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.9%
1/35 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
11.8%
4/34 • Number of events 4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
3.0%
1/33 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/11 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
6.2%
1/16 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/17 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/13 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/3 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/3 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/3 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
25.0%
1/4 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
12.5%
1/8 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Androgenetic alopecia
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
20.0%
1/5 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
9.1%
3/33 • Number of events 3 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.9%
1/35 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
8.8%
3/34 • Number of events 4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
9.1%
3/33 • Number of events 3 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
25.0%
1/4 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/35 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/34 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
6.1%
2/33 • Number of events 2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/33 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
2.9%
1/35 • Number of events 1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
5.9%
2/34 • Number of events 2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
9.1%
3/33 • Number of events 3 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/5 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/2 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/4 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/8 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/1 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
0.00%
0/9 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
—
0/0 • Baseline Up To 45 Weeks
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60