Trial Outcomes & Findings for Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis (NCT NCT03989349)
NCT ID: NCT03989349
Last Updated: 2024-08-14
Results Overview
IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of atopic dermatitis (AD) and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data at Week 16 were considered non-responders.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
787 participants
Primary outcome timeframe
Week 16
Results posted on
2024-08-14
Participant Flow
The study was conducted at 136 active sites in Belgium, Bulgaria, Estonia, France, Georgia, Germany, Hungary, Italy, Poland, Singapore, and the United States from 27 June 2019 to 26 September 2022.
A total of 787 randomized 2:1 to receive either nemolizumab or placebo.At Week 16, 235 nemolizumab treated participants were clinical responders(IGA of 0\[clear\] or 1\[almost clear\]or Eczema Area and Severity Index \[EASI\]-75) re-randomized to receive nemolizumab Q4,nemolizumab Q8W,or placebo during Maintenance Period.85 participants received placebo in Initial Treatment, responded to placebo at Week 16,re-assigned to placebo and continued to receive placebo Q4W in Maintenance Period.
Participant milestones
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
Participants received nemolizumab 30 milligrams (mg) via 2 subcutaneous (SC) injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
Participants received placebo via 2 subcutaneous (SC) injections at Day 1, thereafter, every 4 weeks (Q4W) at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4W
Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
|
Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q8W
Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, every 8 weeks (Q8W) at Weeks 16, 24, 32, and 40 by a single SC injection during Maintenance Period.
|
Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Placebo Q4W
Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
|
Maintenance Period (Week 16-Week 48): Placebo Q4W Re-assigned to Placebo Q4W
Participants who received placebo, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
|
|---|---|---|---|---|---|---|
|
Initial Treatment(Day 1-Week 16 Predose)
STARTED
|
522
|
265
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Treated
|
519
|
263
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Safety Population
|
519
|
263
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
COMPLETED
|
470
|
241
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
NOT COMPLETED
|
52
|
24
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16-Week 48)
STARTED
|
0
|
0
|
79
|
78
|
78
|
85
|
|
Maintenance Period (Week 16-Week 48)
Treated
|
0
|
0
|
78
|
78
|
77
|
84
|
|
Maintenance Period (Week 16-Week 48)
Safety Population
|
0
|
0
|
79
|
77
|
77
|
84
|
|
Maintenance Period (Week 16-Week 48)
COMPLETED
|
0
|
0
|
65
|
68
|
65
|
74
|
|
Maintenance Period (Week 16-Week 48)
NOT COMPLETED
|
0
|
0
|
14
|
10
|
13
|
11
|
Reasons for withdrawal
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
Participants received nemolizumab 30 milligrams (mg) via 2 subcutaneous (SC) injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
Participants received placebo via 2 subcutaneous (SC) injections at Day 1, thereafter, every 4 weeks (Q4W) at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4W
Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
|
Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q8W
Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, every 8 weeks (Q8W) at Weeks 16, 24, 32, and 40 by a single SC injection during Maintenance Period.
|
Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Placebo Q4W
Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
|
Maintenance Period (Week 16-Week 48): Placebo Q4W Re-assigned to Placebo Q4W
Participants who received placebo, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
|
|---|---|---|---|---|---|---|
|
Initial Treatment(Day 1-Week 16 Predose)
Lack of Efficacy
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Adverse Event
|
17
|
4
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Withdrawal by Subject
|
24
|
15
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Protocol Deviation
|
3
|
2
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Physician/principal investigator decision
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Randomized but not Treated
|
3
|
2
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16-Week 48)
Lack of Efficacy
|
0
|
0
|
2
|
2
|
3
|
3
|
|
Maintenance Period (Week 16-Week 48)
Adverse Event
|
0
|
0
|
3
|
2
|
3
|
2
|
|
Maintenance Period (Week 16-Week 48)
Withdrawal by Subject
|
0
|
0
|
2
|
3
|
1
|
4
|
|
Maintenance Period (Week 16-Week 48)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
3
|
0
|
|
Maintenance Period (Week 16-Week 48)
Physician Decision
|
0
|
0
|
1
|
1
|
0
|
1
|
|
Maintenance Period (Week 16-Week 48)
Other
|
0
|
0
|
4
|
2
|
2
|
0
|
|
Maintenance Period (Week 16-Week 48)
Re-randomized/Re-assigned but not Treated
|
0
|
0
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=522 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=265 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Total
n=787 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
91 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
394 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
603 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
270 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
406 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
252 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
381 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
464 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
708 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
458 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
685 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of atopic dermatitis (AD) and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data at Week 16 were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=522 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=265 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population
|
37.7 percentage of participants
|
26.0 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of AD and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=316 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=164 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Severe Pruritus Population
|
36.7 percentage of participants
|
22.0 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
EASI-75 was defined as \>=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD(erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head \& neck, upper limbs, trunk \& lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=522 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=265 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population
|
42.1 percentage of participants
|
30.2 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
EASI-75 was defined as \>=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD(erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head \& neck, upper limbs, trunk \& lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=316 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=164 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: Severe Pruritus Population
|
41.1 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=522 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=265 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population
|
41.0 percentage of participants
|
18.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=316 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=164 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population
|
48.4 percentage of participants
|
21.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=522 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=265 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population
|
28.4 percentage of participants
|
11.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=316 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=164 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population
|
26.9 percentage of participants
|
8.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=522 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=265 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population
|
33.5 percentage of participants
|
16.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=316 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=164 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population
|
42.7 percentage of participants
|
20.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=522 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=265 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population
|
26.1 percentage of participants
|
5.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=316 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=164 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population
|
30.4 percentage of participants
|
7.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=522 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=265 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population
|
15.9 percentage of participants
|
2.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=316 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=164 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population
|
11.1 percentage of participants
|
1.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=522 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=265 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population
|
16.9 percentage of participants
|
1.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=316 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=164 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population
|
19.3 percentage of participants
|
3.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 1Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=522 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=265 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population
|
6.7 percentage of participants
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 1Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=316 Participants
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=164 Participants
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: Severe Pruritus Population
|
8.5 percentage of participants
|
0.6 percentage of participants
|
Adverse Events
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
Serious events: 13 serious events
Other events: 71 other events
Deaths: 0 deaths
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q4W
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q8W
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Placebo Q4W
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Maintenance Period (Week 16- Week 48): Placebo Q4W Re-assigned to Placebo Q4W
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=519 participants at risk
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=263 participants at risk
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q4W
n=79 participants at risk
Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
|
Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q8W
n=77 participants at risk
Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, every 8 weeks (Q8W) at Weeks 16, 24, 32, and 40 by a single SC injection during Maintenance Period.
|
Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Placebo Q4W
n=77 participants at risk
Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
|
Maintenance Period (Week 16- Week 48): Placebo Q4W Re-assigned to Placebo Q4W
n=84 participants at risk
Participants who received placebo, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.19%
1/519 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/519 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Congenital, familial and genetic disorders
Congenital cyst
|
0.19%
1/519 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.19%
1/519 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Eosinophilic colitis
|
0.19%
1/519 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.19%
1/519 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/519 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
1.3%
1/79 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/519 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.19%
1/519 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.19%
1/519 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
0.19%
1/519 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.19%
1/519 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Infected cyst
|
0.19%
1/519 • Number of events 2 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.19%
1/519 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Superinfection bacterial
|
0.19%
1/519 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/519 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/519 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.38%
1/263 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/519 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
1.3%
1/79 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/519 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
1.3%
1/79 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/519 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
1.2%
1/84 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.39%
2/519 • Number of events 2 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
1.3%
1/79 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.19%
1/519 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Psychogenic tremor
|
0.19%
1/519 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/519 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
1.3%
1/79 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/519 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
1.3%
1/77 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/519 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
1.3%
1/79 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/519 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
1.3%
1/77 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.58%
3/519 • Number of events 3 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/263 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/79 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/77 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/84 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=519 participants at risk
Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=263 participants at risk
Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period.
|
Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q4W
n=79 participants at risk
Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
|
Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q8W
n=77 participants at risk
Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, every 8 weeks (Q8W) at Weeks 16, 24, 32, and 40 by a single SC injection during Maintenance Period.
|
Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Placebo Q4W
n=77 participants at risk
Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
|
Maintenance Period (Week 16- Week 48): Placebo Q4W Re-assigned to Placebo Q4W
n=84 participants at risk
Participants who received placebo, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period.
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
6.6%
34/519 • Number of events 42 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
5.7%
15/263 • Number of events 15 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
7.6%
6/79 • Number of events 7 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
3.9%
3/77 • Number of events 4 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
7.8%
6/77 • Number of events 7 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
6.0%
5/84 • Number of events 5 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
19/519 • Number of events 24 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
4.6%
12/263 • Number of events 13 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
8.9%
7/79 • Number of events 12 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
3.9%
3/77 • Number of events 6 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
6.5%
5/77 • Number of events 6 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
7.1%
6/84 • Number of events 8 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
2.7%
14/519 • Number of events 14 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
3.0%
8/263 • Number of events 8 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
3.8%
3/79 • Number of events 3 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
5.2%
4/77 • Number of events 4 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
16.9%
13/77 • Number of events 13 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
7.1%
6/84 • Number of events 6 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
6/519 • Number of events 6 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
1.9%
5/263 • Number of events 5 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
1.3%
1/79 • Number of events 1 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
2.6%
2/77 • Number of events 2 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
6.5%
5/77 • Number of events 5 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
2.4%
2/84 • Number of events 2 • Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The safety population comprised all participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER