Trial Outcomes & Findings for Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (NCT NCT02277743)

Results Overview

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 response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

671 participants

Primary outcome timeframe

Week 16

Results posted on

2017-11-21

Participant Flow

The study was conducted in 10 countries between 28 Oct 2014 and 12 Feb 2016. A total of 917 participants were screened in the study.

Out of 917 participants, 671 were randomized and 669 were treated in the study. Participants were randomized in 1:1:1 ratio to receive Dupilumab 300 mg once weekly (qw), Dupilumab 300 mg every 2 weeks (q2w) or Placebo qw.

Participant milestones

Participant milestones
Measure	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.	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 placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	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 of Dupilumab qw from Week 1 to Week 15.
Overall Study STARTED	224	224	223
Overall Study Treated	223	223	223
Overall Study Safety Population	222	229	218
Overall Study COMPLETED	184	208	197
Overall Study NOT COMPLETED	40	16	26

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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 placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	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 of Dupilumab qw from Week 1 to Week 15.
Overall Study Protocol Violation	1	1	1
Overall Study Adverse Event	10	6	6
Overall Study Lack of Efficacy	11	4	3
Overall Study Other than specified above	18	5	16

Baseline Characteristics

Number of participants analyzed = participants with available data for the baseline parameter.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=224 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.	Dupilumab 300 mg q2w n=224 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=223 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 qw from Week 1 to Week 15.	Total n=671 Participants Total of all reporting groups
Age, Continuous	39.5 years STANDARD_DEVIATION 13.91 • n=224 Participants	39.8 years STANDARD_DEVIATION 14.68 • n=224 Participants	39.3 years STANDARD_DEVIATION 14.39 • n=223 Participants	39.5 years STANDARD_DEVIATION 14.31 • n=671 Participants
Sex: Female, Male Female	106 Participants n=224 Participants	94 Participants n=224 Participants	81 Participants n=223 Participants	281 Participants n=671 Participants
Sex: Female, Male Male	118 Participants n=224 Participants	130 Participants n=224 Participants	142 Participants n=223 Participants	390 Participants n=671 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=224 Participants	6 Participants n=224 Participants	8 Participants n=223 Participants	25 Participants n=671 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	212 Participants n=224 Participants	215 Participants n=224 Participants	212 Participants n=223 Participants	639 Participants n=671 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=224 Participants	3 Participants n=224 Participants	3 Participants n=223 Participants	7 Participants n=671 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=224 Participants	0 Participants n=224 Participants	0 Participants n=223 Participants	0 Participants n=671 Participants
Race (NIH/OMB) Asian	56 Participants n=224 Participants	54 Participants n=224 Participants	51 Participants n=223 Participants	161 Participants n=671 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=224 Participants	0 Participants n=224 Participants	0 Participants n=223 Participants	0 Participants n=671 Participants
Race (NIH/OMB) Black or African American	16 Participants n=224 Participants	10 Participants n=224 Participants	20 Participants n=223 Participants	46 Participants n=671 Participants
Race (NIH/OMB) White	146 Participants n=224 Participants	155 Participants n=224 Participants	149 Participants n=223 Participants	450 Participants n=671 Participants
Race (NIH/OMB) More than one race	0 Participants n=224 Participants	0 Participants n=224 Participants	0 Participants n=223 Participants	0 Participants n=671 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=224 Participants	5 Participants n=224 Participants	3 Participants n=223 Participants	14 Participants n=671 Participants
Region of Enrollment North and South America	95 Participants n=224 Participants	95 Participants n=224 Participants	96 Participants n=223 Participants	286 Participants n=671 Participants
Region of Enrollment Asia Pacific	40 Participants n=224 Participants	42 Participants n=224 Participants	38 Participants n=223 Participants	120 Participants n=671 Participants
Region of Enrollment Eastern Europe	23 Participants n=224 Participants	22 Participants n=224 Participants	24 Participants n=223 Participants	69 Participants n=671 Participants
Region of Enrollment Western Europe	66 Participants n=224 Participants	65 Participants n=224 Participants	65 Participants n=223 Participants	196 Participants n=671 Participants
Eczema Area and Severity Index (EASI) Score	34.5 units on scale STANDARD_DEVIATION 14.47 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	33 units on scale STANDARD_DEVIATION 13.57 • n=224 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	33.2 units on scale STANDARD_DEVIATION 13.98 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	33.6 units on scale STANDARD_DEVIATION 14.00 • n=670 Participants • Number of participants analyzed = participants with available data for the baseline parameter.
Investigator's Global Assessment (IGA) Score	3.5 units on a scale STANDARD_DEVIATION 0.5 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	3.5 units on a scale STANDARD_DEVIATION 0.5 • n=224 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	3.5 units on a scale STANDARD_DEVIATION 0.5 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	3.5 units on a scale STANDARD_DEVIATION 0.5 • n=670 Participants • Number of participants analyzed = participants with available data for the baseline parameter.
Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS)	7.4 units on a scale STANDARD_DEVIATION 1.77 • n=224 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	7.2 units on a scale STANDARD_DEVIATION 1.89 • n=224 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	7.2 units on a scale STANDARD_DEVIATION 2.06 • n=221 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	7.3 units on a scale STANDARD_DEVIATION 1.91 • n=669 Participants • Number of participants analyzed = participants with available data for the baseline parameter.
Body Surface Area (BSA) Involvement with AD	57.5 percentage of body surface area STANDARD_DEVIATION 23.38 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	54.7 percentage of body surface area STANDARD_DEVIATION 23.19 • n=224 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	56.1 percentage of body surface area STANDARD_DEVIATION 22.96 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	56.1 percentage of body surface area STANDARD_DEVIATION 23.17 • n=670 Participants • Number of participants analyzed = participants with available data for the baseline parameter.
SCORing Atopic Dermatitis (SCORAD) Score	68.3 units on a scale STANDARD_DEVIATION 13.96 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	66.9 units on a scale STANDARD_DEVIATION 13.97 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	67.5 units on a scale STANDARD_DEVIATION 13.61 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	67.6 units on a scale STANDARD_DEVIATION 13.84 • n=669 Participants • Number of participants analyzed = participants with available data for the baseline parameter.
Dermatology Life Quality Index (DLQI) Score	14.8 units on a scale STANDARD_DEVIATION 7.23 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	13.9 units on a scale STANDARD_DEVIATION 7.37 • n=224 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	14.1 units on a scale STANDARD_DEVIATION 7.51 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	14.2 units on a scale STANDARD_DEVIATION 7.37 • n=670 Participants • Number of participants analyzed = participants with available data for the baseline parameter.
Patient Oriented Eczema Measure (POEM)	20.3 units on a scale STANDARD_DEVIATION 5.90 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	19.8 units on a scale STANDARD_DEVIATION 6.37 • n=224 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	20.4 units on a scale STANDARD_DEVIATION 6.25 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	20.1 units on a scale STANDARD_DEVIATION 6.17 • n=670 Participants • Number of participants analyzed = participants with available data for the baseline parameter.
Global Individual Signs Score (GISS)	9.0 units on a scale STANDARD_DEVIATION 1.85 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	8.9 units on a scale STANDARD_DEVIATION 1.81 • n=224 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	8.9 units on a scale STANDARD_DEVIATION 1.74 • n=223 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	9.0 units on a scale STANDARD_DEVIATION 1.80 • n=670 Participants • Number of participants analyzed = participants with available data for the baseline parameter.
Total Hospital Anxiety Depression Scale (HADS)	12.6 units on a scale STANDARD_DEVIATION 8.33 • n=204 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	12.2 units on a scale STANDARD_DEVIATION 7.26 • n=207 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	12.6 units on a scale STANDARD_DEVIATION 7.95 • n=204 Participants • Number of participants analyzed = participants with available data for the baseline parameter.	12.5 units on a scale STANDARD_DEVIATION 7.85 • n=615 Participants • Number of participants analyzed = participants with available data for the baseline parameter.

PRIMARY outcome

Timeframe: Week 16

Population: Full analysis set included all randomized participants.

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 response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=224 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.	Dupilumab 300 mg q2w n=224 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=223 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 qw from Week 1 to Week 15.
Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16	10.3 percentage of participants	37.9 percentage of participants	37.2 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Full analysis set (FAS) included all randomized participants.

The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=224 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.	Dupilumab 300 mg q2w n=224 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=223 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 qw from Week 1 to Week 15.
Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16	14.7 percentage of participants	51.3 percentage of participants	52.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.

Pruritus NRS was an assessment tool that was used to report the intensity of a 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 \[0 = no itch; 10 = worst itch imaginable\]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=212 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.	Dupilumab 300 mg q2w n=213 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=201 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 qw from Week 1 to Week 15.
Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16	12.3 percentage of participants	40.8 percentage of participants	40.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥3.

Pruritus NRS was an assessment tool that was used to report the intensity of a 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 \[0 = no itch; 10 = worst itch imaginable\]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=221 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.	Dupilumab 300 mg q2w n=220 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=211 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 qw from Week 1 to Week 15.
Percentage of Participants With Improvement (Reduction ≥3 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16	17.2 percentage of participants	46.8 percentage of participants	51.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.

Pruritus NRS was an assessment tool that was used to report the intensity of a 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	Placebo n=96 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.	Dupilumab 300 mg q2w n=169 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=162 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 qw from Week 1 to Week 15.
Percent Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16	-26.8 percent change Standard Deviation 28.38	-51.1 percent change Standard Deviation 28.81	-49.0 percent change Standard Deviation 33.45

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.

Pruritus NRS was an assessment tool that was used to report the intensity of a 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 \[0 = no itch; 10 = worst itch imaginable\]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported. Values after first rescue treatment were set to missing and subjects with missing peak NRS at Week 4 were considered as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=212 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.	Dupilumab 300 mg q2w n=213 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=201 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 qw from Week 1 to Week 15.
Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4	6.1 percentage of participants	16.0 percentage of participants	23.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.

Pruritus NRS was an assessment tool that was used to report the intensity of a 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 \[0 = no itch; 10 = worst itch imaginable\]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=212 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.	Dupilumab 300 mg q2w n=213 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=201 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 qw from Week 1 to Week 15.
Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2	3.3 percentage of participants	9.4 percentage of participants	9.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.

Pruritus NRS was an assessment tool that was used to report the intensity of a 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	Placebo n=96 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.	Dupilumab 300 mg q2w n=169 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=162 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 qw from Week 1 to Week 15.
Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16	-2.13 units on a scale Standard Deviation 2.044	-3.78 units on a scale Standard Deviation 2.325	-3.72 units on a scale Standard Deviation 2.186

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.

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

Outcome measures

Outcome measures
Measure	Placebo n=97 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.	Dupilumab 300 mg q2w n=173 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=162 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 qw from Week 1 to Week 15.
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16	-39.5 percent change Standard Deviation 33.66	-73.9 percent change Standard Deviation 26.28	-73.8 percent change Standard Deviation 26.41

SECONDARY outcome

Timeframe: Week 16

Population: Full analysis set (FAS) included all randomized participants.

The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 16 were considered as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=224 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.	Dupilumab 300 mg q2w n=224 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=223 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 qw from Week 1 to Week 15.
Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16	24.6 percentage of participants	68.8 percentage of participants	61.0 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Full analysis set (FAS) included all randomized participants.

The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-90 scores at Week 16 were considered as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=224 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.	Dupilumab 300 mg q2w n=224 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=223 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 qw from Week 1 to Week 15.
Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16	7.6 percentage of participants	35.7 percentage of participants	33.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.

BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]). It was reported as a percentage of all major body sections combined.

Outcome measures

Outcome measures
Measure	Placebo n=97 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.	Dupilumab 300 mg q2w n=173 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=162 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 qw from Week 1 to Week 15.
Change From Baseline in Percent Body Surface Area (BSA) to Week 16	-17.2 percentage of body surface area Standard Deviation 17.381	-33.72 percentage of body surface area Standard Deviation 19.619	-35.42 percentage of body surface area Standard Deviation 19.926

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.

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	Placebo n=97 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.	Dupilumab 300 mg q2w n=172 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=161 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 qw from Week 1 to Week 15.
Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16	-28.9 percent change Standard Deviation 24.25	-57.2 percent change Standard Deviation 24.03	-56.7 percent change Standard Deviation 24.27

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.

The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.

Outcome measures

Outcome measures
Measure	Placebo n=97 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.	Dupilumab 300 mg q2w n=173 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=162 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 qw from Week 1 to Week 15.
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16	-5.6 units on a scale Standard Deviation 5.86	-9.0 units on a scale Standard Deviation 6.61	-8.8 units on a scale Standard Deviation 6.79

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.

The 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	Placebo n=96 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.	Dupilumab 300 mg q2w n=173 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=162 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 qw from Week 1 to Week 15.
Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16	-5.3 units on a scale Standard Deviation 6.24	-11.5 units on a scale Standard Deviation 7.07	-11.3 units on a scale Standard Deviation 6.36

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.

HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.

Outcome measures

Outcome measures
Measure	Placebo n=82 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.	Dupilumab 300 mg q2w n=159 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=146 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 qw from Week 1 to Week 15.
Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16	-2.7 units on a scale Standard Deviation 4.40	-4.8 units on a scale Standard Deviation 5.50	-4.9 units on a scale Standard Deviation 5.36

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.

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	Placebo n=97 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.	Dupilumab 300 mg q2w n=173 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=162 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 qw from Week 1 to Week 15.
Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 16	-26.2 percent change Standard Deviation 25.70	-52.5 percent change Standard Deviation 27.33	-51.1 percent change Standard Deviation 26.58

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.

Pruritus NRS was an assessment tool that was used to report the intensity of a 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	Placebo n=194 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.	Dupilumab 300 mg q2w n=214 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=212 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 qw from Week 1 to Week 15.
Percent Change From Baseline in Peak Daily Pruritus NRS Score to Week 2	-4.2 percent change Standard Deviation 22.77	-20.4 percent change Standard Deviation 21.40	-18.9 percent change Standard Deviation 28.40

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.

Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study \[Week 28\]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. Statistical significance in the hierarchical testing of secondary hypotheses was broken at this endpoint. Therefore, subsequent secondary efficacy endpoints were not tested for statistical significance.

Outcome measures

Outcome measures
Measure	Placebo n=222 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.	Dupilumab 300 mg q2w n=229 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=218 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 qw from Week 1 to Week 15.
Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.

Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study \[Week 28\]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.

Outcome measures

Outcome measures
Measure	Placebo n=222 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.	Dupilumab 300 mg q2w n=229 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=218 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 qw from Week 1 to Week 15.
Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16	5.0 percentage of participants	3.1 percentage of participants	0.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.

Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study \[Week 28\]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.

Outcome measures

Outcome measures
Measure	Placebo n=222 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.	Dupilumab 300 mg q2w n=229 Participants Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.	Dupilumab 300 mg qw n=218 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 qw from Week 1 to Week 15.
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16	0.9 percentage of participants	1.7 percentage of participants	1.8 percentage of participants

Adverse Events

Placebo

Serious events: 12 serious events

Other events: 97 other events

Deaths: 0 deaths

Dupilumab 300 mg q2w

Serious events: 7 serious events

Other events: 92 other events

Deaths: 0 deaths

Dupilumab 300 mg qw

Serious events: 2 serious events

Other events: 90 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=222 participants at risk Participants exposed to Placebo (for Dupilumab) for 16 weeks (mean exposure of 14 weeks)	Dupilumab 300 mg q2w n=229 participants at risk Participants exposed to Dupilumab 300 mg alternating with placebo qw for 16 weeks (mean exposure of 15 weeks).	Dupilumab 300 mg qw n=218 participants at risk Participants exposed to Dupilumab 300 mg qw for 16 weeks (mean exposure of 15 weeks).
Eye disorders Conjunctivitis allergic	1.4% 3/222 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.	5.2% 12/229 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.	3.7% 8/218 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.
General disorders Injection site reaction	5.9% 13/222 • Number of events 18 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.	8.3% 19/229 • Number of events 63 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.	18.8% 41/218 • Number of events 111 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.
Infections and infestations Nasopharyngitis	9.9% 22/222 • Number of events 30 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.	11.8% 27/229 • Number of events 32 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.	11.9% 26/218 • Number of events 34 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.
Infections and infestations Upper respiratory tract infection	3.2% 7/222 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.	3.1% 7/229 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.	5.5% 12/218 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.
Nervous system disorders Headache	5.9% 13/222 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.	9.2% 21/229 • Number of events 33 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.	5.0% 11/218 • Number of events 15 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Dermatitis atopic	29.7% 66/222 • Number of events 77 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.	15.3% 35/229 • Number of events 44 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.	9.6% 21/218 • Number of events 26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.

Additional Information

Clinical Trial Management

Regeneron Pharmaceuticals, Inc.

Email: [email protected]

Results disclosure agreements

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