Trial Outcomes & Findings for Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis (NCT NCT03985943)
NCT ID: NCT03985943
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
941 participants
Primary outcome timeframe
Week 16
Results posted on
2024-08-14
Participant Flow
The study was conducted at 177 active sites in Australia, Austria, Canada, Czech Republic, Germany, Great Britain, Korea, Latvia, Lithuania, Netherlands, New Zealand, Poland, Spain and the United States from 27 June 2019 to 11 August 2022.
A total of 941 randomized 2:1 to receive either nemolizumab or placebo.At Week 16, 272 nemolizumab-treated participants were clinical responders (defined as IGA of 0\[clear\] or 1\[almost clear\]or Eczema Area and Severity Index \[EASI\]-75) re-randomized to receive nemolizumab Q4W,nemolizumab Q8W,or placebo during Maintenance Period.100 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): 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
Participants received nemolizumab 30 milligrams (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.
|
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 greater than and equal to (\>=) 75 percent (%) 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 20, 28, 36, and 44 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
|
321
|
620
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Safety Population
|
321
|
616
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
COMPLETED
|
296
|
560
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
NOT COMPLETED
|
25
|
60
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16-Week 48)
STARTED
|
0
|
0
|
90
|
91
|
91
|
100
|
|
Maintenance Period (Week 16-Week 48)
Safety Population
|
0
|
0
|
91
|
90
|
91
|
100
|
|
Maintenance Period (Week 16-Week 48)
COMPLETED
|
0
|
0
|
76
|
79
|
69
|
82
|
|
Maintenance Period (Week 16-Week 48)
NOT COMPLETED
|
0
|
0
|
14
|
12
|
22
|
18
|
Reasons for withdrawal
| Measure |
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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
Participants received nemolizumab 30 milligrams (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.
|
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 greater than and equal to (\>=) 75 percent (%) 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 20, 28, 36, and 44 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)
Pregnancy
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Lack of Efficacy
|
2
|
5
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Adverse Event
|
9
|
9
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Subjects request
|
11
|
25
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Lost to Follow-up
|
0
|
10
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Protocol deviation
|
3
|
4
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Physician/Principal Investigators Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Initial Treatment(Day 1-Week 16 Predose)
Randomized but not treated
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16-Week 48)
Lack of Efficacy
|
0
|
0
|
4
|
3
|
12
|
4
|
|
Maintenance Period (Week 16-Week 48)
Adverse Event
|
0
|
0
|
1
|
3
|
1
|
1
|
|
Maintenance Period (Week 16-Week 48)
Subjects request
|
0
|
0
|
6
|
4
|
5
|
9
|
|
Maintenance Period (Week 16-Week 48)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Maintenance Period (Week 16-Week 48)
Protocol Deviation
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Maintenance Period (Week 16-Week 48)
Physician/PI Decision
|
0
|
0
|
2
|
1
|
1
|
2
|
|
Maintenance Period (Week 16-Week 48)
Other
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=321 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=620 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.
|
Total
n=941 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 15.61 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 15.92 • n=7 Participants
|
33.3 years
STANDARD_DEVIATION 17.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=5 Participants
|
297 Participants
n=7 Participants
|
441 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
177 Participants
n=5 Participants
|
323 Participants
n=7 Participants
|
500 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
288 Participants
n=5 Participants
|
552 Participants
n=7 Participants
|
840 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
51 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
244 Participants
n=5 Participants
|
451 Participants
n=7 Participants
|
695 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 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): Placebo
n=321 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=620 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.
|
|---|---|---|
|
Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): Intent-To-Treat (ITT) Population
|
24.6 percentage of participants
|
35.6 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): Placebo
n=210 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=406 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.
|
|---|---|---|
|
Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a >= 2-point Reduction): Severe Pruritus Population
|
21.4 percentage of participants
|
35.5 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. 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. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=321 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=620 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.
|
|---|---|---|
|
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population
|
29.0 percentage of participants
|
43.5 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. 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. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD.
Outcome measures
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=210 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=406 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.
|
|---|---|---|
|
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at 16: Severe Pruritus Population
|
23.8 percentage of participants
|
41.6 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): Placebo
n=321 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=620 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.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population
|
17.8 percentage of participants
|
42.7 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): Placebo
n=210 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=406 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.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population
|
18.6 percentage of participants
|
46.1 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): Placebo
n=321 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=620 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.
|
|---|---|---|
|
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population
|
11.2 percentage of participants
|
30.6 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): Placebo
n=210 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=406 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.
|
|---|---|---|
|
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population
|
7.6 percentage of participants
|
27.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The ITT population consisted of all randomized participants.
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): Placebo
n=321 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=620 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.
|
|---|---|---|
|
Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population
|
19.9 percentage of subjects
|
37.9 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 16Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7.
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): Placebo
n=210 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=406 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.
|
|---|---|---|
|
Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population
|
22.4 percentage of participants
|
42.1 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): Placebo
n=321 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=620 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.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population
|
6.5 percentage of participants
|
27.4 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): Placebo
n=210 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=406 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.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population
|
7.1 percentage of participants
|
28.3 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): Placebo
n=321 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=620 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.
|
|---|---|---|
|
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population
|
3.7 percentage of participants
|
16.0 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): Placebo
n=210 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=406 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.
|
|---|---|---|
|
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population
|
2.9 percentage of participants
|
12.6 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): Placebo
n=321 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=620 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.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population
|
3.1 percentage of participants
|
17.7 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): Placebo
n=210 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=406 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.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population
|
3.8 percentage of participants
|
20.7 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): Placebo
n=321 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=620 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.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population
|
1.2 percentage of participants
|
4.5 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): Placebo
n=210 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=406 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.
|
|---|---|---|
|
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: Severe Pruritus Population
|
1.9 percentage of participants
|
6.2 percentage of participants
|
Adverse Events
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
Serious events: 4 serious events
Other events: 67 other events
Deaths: 0 deaths
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
Serious events: 6 serious events
Other events: 144 other events
Deaths: 0 deaths
Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4W
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q8W
Serious events: 3 serious events
Other events: 28 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: 33 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: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=321 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=616 participants at risk
Participants received nemolizumab 30 milligrams (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.
|
Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4W
n=91 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=90 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=91 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=100 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.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.31%
1/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.16%
1/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.16%
1/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.16%
1/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.16%
1/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.93%
3/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.32%
2/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Goitre
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.1%
1/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.1%
1/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.1%
1/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.1%
1/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.1%
1/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.1%
1/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.1%
1/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Periarthiritis
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.1%
1/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmablastic lymphoma
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.1%
1/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.1%
1/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
0.00%
0/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.0%
1/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Initial Treatment Period (Baseline - Week 16 Predose): Placebo
n=321 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.
|
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg
n=616 participants at risk
Participants received nemolizumab 30 milligrams (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.
|
Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4W
n=91 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=90 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=91 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=100 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.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
1.9%
6/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.6%
10/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
9.9%
9/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
10.0%
9/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
6.6%
6/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
10.0%
10/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
8/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.5%
9/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
7.7%
7/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
5.6%
5/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
7.7%
7/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
6.0%
6/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
14/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.5%
9/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
3.3%
3/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
3.3%
3/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
5.5%
5/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
9.0%
9/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
3.4%
11/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
4.5%
28/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
5.5%
5/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
5.6%
5/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
3.3%
3/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
1.0%
1/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.0%
13/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
5.4%
33/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
3.3%
3/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
6.7%
6/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
5.5%
5/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
5.0%
5/100 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
10.3%
33/321 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
11.9%
73/616 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
7.7%
7/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
8.9%
8/90 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
13.2%
12/91 • 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 SP comprised all participants who received at least 1 dose of study drug.
|
10.0%
10/100 • 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 SP 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