Trial Outcomes & Findings for Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (NCT NCT01859988)

Results Overview

The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

380 participants

Primary outcome timeframe

Baseline to Week 16

Results posted on

2017-08-28

Participant Flow

The study was conducted at 95 study sites in 7 countries. A total of 452 participants were screened between 15 May 2013 and 10 January 2014. 380 participants were randomized and 379 were treated. 72 participants were screen failures mainly due to exclusion criteria met and inclusion criteria not met.

Randomization was stratified by disease severity (moderate Investigator's global assessment \[IGA\] = 3 versus severe IGA = 4 atopic dermatitis) and region (Japan versus rest of world). Assignment to arms was done centrally in 1:1:1:1:1:1 ratio for Dupilumab (300 mg qw; 300 mg q2w; 200 mg q2w; 300 mg q4w and 100 mg q4w) and Placebo.

Participant milestones

Participant milestones
Measure	Dupilumab 300 mg qw Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection every week (qw) from Week 1 to Week 15.	Dupilumab 300 mg q2w Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 15.	Dupilumab 200 mg q2w Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab every 4 weeks (q4w) and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Overall Study STARTED	63	64	62	65	65	61
Overall Study Treated	63	64	61	65	65	61
Overall Study COMPLETED	52	52	34	55	42	42
Overall Study NOT COMPLETED	11	12	28	10	23	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Dupilumab 300 mg qw Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection every week (qw) from Week 1 to Week 15.	Dupilumab 300 mg q2w Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 15.	Dupilumab 200 mg q2w Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab every 4 weeks (q4w) and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Overall Study Withdrawal by Subject	6	3	4	3	2	2
Overall Study Lack of Efficacy	1	1	5	0	7	9
Overall Study Physician Decision	1	3	1	3	4	1
Overall Study Adverse Event	2	1	3	1	2	2
Overall Study Lost to Follow-up	1	2	3	0	3	2
Overall Study Protocol Violation	0	0	1	0	0	0
Overall Study Other than specified above	0	2	11	3	5	3

Baseline Characteristics

Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dupilumab 300 mg qw n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=64 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=61 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=61 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.	Total n=379 Participants Total of all reporting groups
Age, Continuous	36.2 years STANDARD_DEVIATION 10.74 • n=5 Participants	39.4 years STANDARD_DEVIATION 12.06 • n=7 Participants	35.8 years STANDARD_DEVIATION 14.90 • n=5 Participants	36.8 years STANDARD_DEVIATION 10.77 • n=4 Participants	36.6 years STANDARD_DEVIATION 11.55 • n=21 Participants	37.2 years STANDARD_DEVIATION 13.10 • n=8 Participants	37.0 years STANDARD_DEVIATION 12.06 • n=8 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	23 Participants n=7 Participants	25 Participants n=5 Participants	25 Participants n=4 Participants	31 Participants n=21 Participants	21 Participants n=8 Participants	145 Participants n=8 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	41 Participants n=7 Participants	36 Participants n=5 Participants	40 Participants n=4 Participants	34 Participants n=21 Participants	40 Participants n=8 Participants	234 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set (FAS) that included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed = participants with EASI score assessment at specified time-point. Efficacy data was set to missing after use of rescue medication. Missing values imputed by last observation carried forward (LOCF).

The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Outcome measures

Outcome measures
Measure	Dupilumab 300 mg qw n=61 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=60 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=64 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=61 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16	-75.5 Percent change Standard Deviation 26.86	-70.5 Percent change Standard Deviation 35.09	-67.4 Percent change Standard Deviation 31.97	-64.9 Percent change Standard Deviation 37.21	-46.7 Percent change Standard Deviation 41.96	-20.2 Percent change Standard Deviation 46.15

SECONDARY outcome

Timeframe: Week 16

Population: Analysis was performed on FAS.

IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a static 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders.

Outcome measures

Outcome measures
Measure	Dupilumab 300 mg qw n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=64 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=61 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=61 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16	33.3 Percentage of participants Interval 21.95 to 46.34	29.7 Percentage of participants Interval 18.91 to 42.42	27.9 Percentage of participants Interval 17.15 to 40.83	21.5 Percentage of participants Interval 12.31 to 33.49	12.3 Percentage of participants Interval 5.47 to 22.82	1.6 Percentage of participants Interval 0.04 to 8.8

SECONDARY outcome

Timeframe: Week 16

Population: Analysis was performed on FAS.

IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic success is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders.

Outcome measures

Outcome measures
Measure	Dupilumab 300 mg qw n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=64 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=61 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=61 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16	50.8 Percentage of participants Interval 37.89 to 63.62	46.9 Percentage of participants Interval 34.28 to 59.77	42.6 Percentage of participants Interval 30.04 to 55.94	35.4 Percentage of participants Interval 23.92 to 48.23	20.0 Percentage of participants Interval 11.1 to 31.77	9.8 Percentage of participants Interval 3.7 to 20.19

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on FAS. Here, number of participants analyzed = participants with pruritus NRS assessment at specified time-point. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.

Pruritus NRS is an assessment tool that is used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]).

Outcome measures

Outcome measures
Measure	Dupilumab 300 mg qw n=62 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=58 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=64 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=58 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16	-52.85 Percent change Standard Deviation 31.368	-46.22 Percent change Standard Deviation 31.964	-40.6 Percent change Standard Deviation 33.073	-38.69 Percent change Standard Deviation 38.366	-21.47 Percent change Standard Deviation 32.952	-0.43 Percent change Standard Deviation 38.423

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on FAS. Here, number of participants analyzed =participants with pruritus NRS assessment at specified time-points. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.

Pruritus NRS is an assessment tool that is used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]).

Outcome measures

Outcome measures
Measure	Dupilumab 300 mg qw n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=64 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=61 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=61 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16 Baseline	6.54 units on a scale Standard Deviation 1.54	6.74 units on a scale Standard Deviation 2.072	6.98 units on a scale Standard Deviation 2.315	6.84 units on a scale Standard Deviation 1.853	6.71 units on a scale Standard Deviation 1.882	6.34 units on a scale Standard Deviation 1.832
Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16 Week 16	3.07 units on a scale Standard Deviation 2.148	3.64 units on a scale Standard Deviation 2.388	4.21 units on a scale Standard Deviation 2.763	3.99 units on a scale Standard Deviation 2.449	5.26 units on a scale Standard Deviation 2.465	6.05 units on a scale Standard Deviation 2.312
Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16 Change at Week 16	-3.48 units on a scale Standard Deviation 2.32	-3.16 units on a scale Standard Deviation 2.467	-2.77 units on a scale Standard Deviation 2.595	-2.79 units on a scale Standard Deviation 2.609	-1.46 units on a scale Standard Deviation 2.038	-0.27 units on a scale Standard Deviation 2.28

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on FAS. Here, number of participants analyzed = participants with EASI score assessment at specified time-points. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.

The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Outcome measures

Outcome measures
Measure	Dupilumab 300 mg qw n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=64 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=61 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=61 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Absolute Change in EASI Score From Baseline to Week 16 Baseline	30.1 Units on a scale Standard Error 11.23	33.8 Units on a scale Standard Error 14.52	32.9 Units on a scale Standard Error 15.5	29.4 Units on a scale Standard Error 11.48	32.2 Units on a scale Standard Error 13.49	32.9 Units on a scale Standard Error 13.77
Absolute Change in EASI Score From Baseline to Week 16 Week 16	7.2 Units on a scale Standard Error 8.83	10.7 Units on a scale Standard Error 12.89	10.9 Units on a scale Standard Error 12.41	9.8 Units on a scale Standard Error 11.16	17.4 Units on a scale Standard Error 15.28	25.6 Units on a scale Standard Error 18.32
Absolute Change in EASI Score From Baseline to Week 16 Change at Week 16	-23.1 Units on a scale Standard Error 1.70	-21.1 Units on a scale Standard Error 1.68	-20.7 Units on a scale Standard Error 1.71	-20.4 Units on a scale Standard Error 1.62	-13.8 Units on a scale Standard Error 1.64	-5.8 Units on a scale Standard Error 1.71

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on FAS. Here, number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF.

SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).

Outcome measures

Outcome measures
Measure	Dupilumab 300 mg qw n=61 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=60 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=64 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=60 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline to Week 16	-56.9 Percent change Standard Error 4.12	-51.2 Percent change Standard Error 4.05	-46.0 Percent change Standard Error 4.12	-48.8 Percent change Standard Error 3.95	-26.6 Percent change Standard Error 3.98	-13.8 Percent change Standard Error 4.14

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on FAS. Here, number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF.

SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).

Outcome measures

Outcome measures
Measure	Dupilumab 300 mg qw n=61 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=60 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=64 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=60 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Absolute Change in SCORAD Scores From Baseline to Week 16	-38.2 units on a scale Standard Error 2.76	-34.4 units on a scale Standard Error 2.71	-30.9 units on a scale Standard Error 2.76	-33.1 units on a scale Standard Error 2.64	-18.0 units on a scale Standard Error 2.66	-10.5 units on a scale Standard Error 2.77

SECONDARY outcome

Timeframe: Week 16

Population: Analysis was performed on FAS. Participants with a missing EASI score at Week 16 were treated as non-responders.

The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50, EASI-75 and EASI-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in EASI score respectively from baseline to Week 16.

Outcome measures

Outcome measures
Measure	Dupilumab 300 mg qw n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=64 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=61 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=61 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score (EASI-50, EASI-75 and EASI-90 Respectively) at Week 16 Reduction of 90%	36.5 Percentage of participants Interval 24.73 to 49.6	29.7 Percentage of participants Interval 18.91 to 42.42	31.1 Percentage of participants Interval 19.9 to 44.29	29.2 Percentage of participants Interval 18.6 to 41.83	15.4 Percentage of participants Interval 7.63 to 26.48	3.3 Percentage of participants Interval 0.4 to 11.35
Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score (EASI-50, EASI-75 and EASI-90 Respectively) at Week 16 Reduction of 50%	82.5 Percentage of participants Interval 70.9 to 90.95	78.1 Percentage of participants Interval 66.03 to 87.49	62.3 Percentage of participants Interval 48.96 to 74.39	70.8 Percentage of participants Interval 58.17 to 81.4	44.6 Percentage of participants Interval 32.27 to 57.47	29.5 Percentage of participants Interval 18.52 to 42.57
Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score (EASI-50, EASI-75 and EASI-90 Respectively) at Week 16 Reduction of 75%	60.3 Percentage of participants Interval 47.2 to 72.43	53.1 Percentage of participants Interval 40.23 to 65.72	55.7 Percentage of participants Interval 42.45 to 68.45	49.2 Percentage of participants Interval 36.6 to 61.93	29.2 Percentage of participants Interval 18.6 to 41.83	11.5 Percentage of participants Interval 4.74 to 22.22

SECONDARY outcome

Timeframe: Week 16

Population: Analysis was performed on FAS. Participants with a missing SCORAD score at Week 16 were treated as non-responders.

SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). SCORAD-50, SCORAD-75 and SCORAD-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in SCORAD score respectively from baseline to Week 16.

Outcome measures

Outcome measures
Measure	Dupilumab 300 mg qw n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=64 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=61 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=61 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16 Reduction of 50%	68.3 Percentage of participants Interval 55.3 to 79.4	59.4 Percentage of participants Interval 46.4 to 71.5	52.5 Percentage of participants Interval 39.3 to 65.4	55.4 Percentage of participants Interval 42.5 to 67.7	26.2 Percentage of participants Interval 16.0 to 38.5	19.7 Percentage of participants Interval 10.6 to 31.8
Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16 Reduction of 75%	23.8 Percentage of participants Interval 14.0 to 36.2	25.0 Percentage of participants Interval 15.0 to 37.4	16.4 Percentage of participants Interval 8.2 to 28.1	21.5 Percentage of participants Interval 12.3 to 33.5	7.7 Percentage of participants Interval 2.5 to 17.0	3.3 Percentage of participants Interval 0.4 to 11.3
Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16 Reduction of 90%	6.3 Percentage of participants Interval 1.8 to 15.5	6.3 Percentage of participants Interval 1.7 to 15.2	4.9 Percentage of participants Interval 1.0 to 13.7	3.1 Percentage of participants Interval 0.4 to 10.7	3.1 Percentage of participants Interval 0.4 to 10.7	0.0 Percentage of participants Interval 0.0 to 5.9

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on FAS. Here, number of participants analyzed = participants with POEM score assessment at specified time-points. Missing values imputed by LOCF.

POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life \[QOL\]).

Outcome measures

Outcome measures
Measure	Dupilumab 300 mg qw n=61 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=59 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=64 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=59 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16	-57.3 Percent change Standard Error 4.52	-44.0 Percent change Standard Error 4.44	-49.2 Percent change Standard Error 5.54	-46.6 Percent change Standard Error 4.33	-14.2 Percent change Standard Error 4.35	0.2 Percent change Standard Error 4.61

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on FAS. Here, number of participants analyzed = participants with POEM score assessment at specified time-points. Missing values imputed by LOCF.

POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life \[QOL\]).

Outcome measures

Outcome measures
Measure	Dupilumab 300 mg qw n=61 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=59 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=64 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=59 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Absolute Change in POEM Scores From Baseline to Week 16	-12.1 units on a scale Standard Error 0.88	-9.8 units on a scale Standard Error 0.87	-10.4 units on a scale Standard Error 0.89	-9.9 units on a scale Standard Error 0.85	-3.3 units on a scale Standard Error 0.85	-1.1 units on a scale Standard Error 0.90

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on FAS. Here, number of participants analyzed = participants with GISS score assessment at specified time-points. Missing values imputed by LOCF.

Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).

Outcome measures

Outcome measures
Measure	Dupilumab 300 mg qw n=61 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=60 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=64 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=61 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16 Erythema	-0.9 units on a scale Standard Error 0.10	-0.9 units on a scale Standard Error 0.10	-0.8 units on a scale Standard Error 0.10	-0.8 units on a scale Standard Error 0.10	-0.4 units on a scale Standard Error 0.10	-0.2 units on a scale Standard Error 0.10
Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16 Infiltration/Papulation	-1.2 units on a scale Standard Error 0.11	-1.1 units on a scale Standard Error 0.11	-1.0 units on a scale Standard Error 0.11	-1.1 units on a scale Standard Error 0.10	-0.6 units on a scale Standard Error 0.11	-0.3 units on a scale Standard Error 0.11
Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16 Excoriations	-1.4 units on a scale Standard Error 0.11	-1.4 units on a scale Standard Error 0.11	-1.1 units on a scale Standard Error 0.11	-1.3 units on a scale Standard Error 0.11	-0.6 units on a scale Standard Error 0.11	-0.4 units on a scale Standard Error 0.11
Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16 Lichenification	-1.1 units on a scale Standard Error 0.12	-1.1 units on a scale Standard Error 0.11	-1.0 units on a scale Standard Error 0.12	-1.1 units on a scale Standard Error 0.11	-0.7 units on a scale Standard Error 0.11	-0.3 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on FAS. Here, number of participants analyzed = participants with GISS score assessment at specified time-points. Missing values imputed by LOCF.

Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none,1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).

Outcome measures

Outcome measures
Measure	Dupilumab 300 mg qw n=61 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=63 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=60 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Dupilumab 100 mg q4w n=64 Participants Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15.	Placebo n=61 Participants Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Changes in GISS Cumulative Score From Baseline to Week 16	-4.6 units on a scale Standard Error 0.38	-4.5 units on a scale Standard Error 0.37	-3.9 units on a scale Standard Error 0.38	-4.3 units on a scale Standard Error 0.37	-2.3 units on a scale Standard Error 0.37	-1.2 units on a scale Standard Error 0.38

Adverse Events

Dupilumab 300 mg qw

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

Dupilumab 300 mg q2w

Serious events: 2 serious events

Other events: 34 other events

Deaths: 0 deaths

Dupilumab 200 mg q2w

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Dupilumab 300 mg q4w

Serious events: 3 serious events

Other events: 39 other events

Deaths: 0 deaths

Dupilumab 100 mg q4w

Serious events: 5 serious events

Other events: 38 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dupilumab 300 mg qw n=63 participants at risk Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=64 participants at risk Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=61 participants at risk Participants who received 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 participants at risk Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.	Dupilumab 100 mg q4w n=65 participants at risk Participants who received 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.	Placebo n=61 participants at risk Participants who received 2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection every week (qw) from Week 1 to Week 15.
Congenital, familial and genetic disorders Hip dysplasia	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/64 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/61 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Cardiac disorders Tachycardia	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/64 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/61 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Immune system disorders Anaphylactic shock	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/64 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/61 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Infections and infestations Cellulitis	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/64 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.5% 1/65 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Infections and infestations Peritonsillar abscess	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/64 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.5% 1/65 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Infections and infestations Viral infection	1.6% 1/63 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/64 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/64 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/61 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Nervous system disorders Syncope	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/64 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Psychiatric disorders Suicidal ideation	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/64 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.5% 1/65 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/64 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.5% 1/65 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/64 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/61 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/64 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	6.2% 4/65 • Number of events 5 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/61 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Skin and subcutaneous tissue disorders Dermatitis exfoliative	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/64 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.5% 1/65 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Surgical and medical procedures Abortion induced	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/64 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/61 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).

Other adverse events

Other adverse events
Measure	Dupilumab 300 mg qw n=63 participants at risk Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.	Dupilumab 300 mg q2w n=64 participants at risk Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 200 mg q2w n=61 participants at risk Participants who received 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.	Dupilumab 300 mg q4w n=65 participants at risk Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.	Dupilumab 100 mg q4w n=65 participants at risk Participants who received 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.	Placebo n=61 participants at risk Participants who received 2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection every week (qw) from Week 1 to Week 15.
Eye disorders Conjunctivitis	6.3% 4/63 • Number of events 5 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/64 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.5% 1/65 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Eye disorders Conjunctivitis allergic	4.8% 3/63 • Number of events 5 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	3.1% 2/64 • Number of events 4 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	9.8% 6/61 • Number of events 9 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	4.6% 3/65 • Number of events 3 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.5% 1/65 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	3.3% 2/61 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Gastrointestinal disorders Abdominal pain upper	1.6% 1/63 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	3.1% 2/64 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	6.2% 4/65 • Number of events 4 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/61 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Gastrointestinal disorders Vomiting	1.6% 1/63 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/64 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	6.6% 4/61 • Number of events 7 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	4.9% 3/61 • Number of events 3 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
General disorders Fatigue	3.2% 2/63 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/64 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/61 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	6.2% 4/65 • Number of events 4 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	4.9% 3/61 • Number of events 3 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Infections and infestations Herpes simplex	1.6% 1/63 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	3.1% 2/64 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	4.9% 3/61 • Number of events 4 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.5% 1/65 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	7.7% 5/65 • Number of events 7 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Infections and infestations Nasopharyngitis	25.4% 16/63 • Number of events 23 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	25.0% 16/64 • Number of events 18 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	26.2% 16/61 • Number of events 25 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	32.3% 21/65 • Number of events 29 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	30.8% 20/65 • Number of events 29 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	26.2% 16/61 • Number of events 23 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Infections and infestations Oral herpes	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	4.7% 3/64 • Number of events 5 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	3.3% 2/61 • Number of events 4 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	4.6% 3/65 • Number of events 4 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	7.7% 5/65 • Number of events 8 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Infections and infestations Upper respiratory tract infection	7.9% 5/63 • Number of events 7 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	9.4% 6/64 • Number of events 8 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	3.3% 2/61 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	7.7% 5/65 • Number of events 6 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	7.7% 5/65 • Number of events 7 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	18.0% 11/61 • Number of events 11 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Infections and infestations Urinary tract infection	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	4.7% 3/64 • Number of events 5 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	9.8% 6/61 • Number of events 7 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	4.6% 3/65 • Number of events 3 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	3.1% 2/65 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	3.3% 2/61 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Investigations Blood triglycerides increased	0.00% 0/63 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/64 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	6.2% 4/65 • Number of events 5 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Musculoskeletal and connective tissue disorders Arthralgia	1.6% 1/63 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	6.2% 4/64 • Number of events 4 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	6.6% 4/61 • Number of events 5 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.5% 1/65 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.5% 1/65 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Musculoskeletal and connective tissue disorders Back pain	3.2% 2/63 • Number of events 16 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	3.1% 2/64 • Number of events 3 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	3.1% 2/65 • Number of events 5 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	4.6% 3/65 • Number of events 3 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	8.2% 5/61 • Number of events 5 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Nervous system disorders Headache	12.7% 8/63 • Number of events 40 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	7.8% 5/64 • Number of events 13 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	14.8% 9/61 • Number of events 24 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	7.7% 5/65 • Number of events 6 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	10.8% 7/65 • Number of events 18 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	3.3% 2/61 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Respiratory, thoracic and mediastinal disorders Cough	6.3% 4/63 • Number of events 4 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	6.2% 4/64 • Number of events 4 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	3.3% 2/61 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.5% 1/65 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/61 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Skin and subcutaneous tissue disorders Dermatitis atopic	12.7% 8/63 • Number of events 9 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	20.3% 13/64 • Number of events 19 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	13.1% 8/61 • Number of events 10 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	15.4% 10/65 • Number of events 12 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	16.9% 11/65 • Number of events 13 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	16.4% 10/61 • Number of events 12 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).
Skin and subcutaneous tissue disorders Urticaria	1.6% 1/63 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/64 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	1.6% 1/61 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/65 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	6.2% 4/65 • Number of events 5 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).	0.00% 0/61 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit \[Week 32\]).

Additional Information

Clinical Trial Management

Regeneron Pharmaceuticals, Inc

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Not less than 45 days prior to submission for publication or presentation, the Institution shall, or cause the Principal Investigator to, provide the Sponsor with a copy of the Manuscript. The Institution shall consider in good faith any comments from the Sponsor regarding the content, and shall delete Confidential Information upon written request of the Sponsor. At the Sponsor's request, the Institution shall delay publication for an additional 60 days to allow patent applications to be filed.
Publication restrictions are in place

Restriction type: OTHER