Trial Outcomes & Findings for Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD) (NCT NCT03345914)

Results Overview

The IGA was an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe). The full analysis set (FAS) included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Values after first rescue treatment used were set to missing. Participants with missing score at Week 16 were considered as a non-responder.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

367 participants

Primary outcome timeframe

Week 16

Results posted on

2020-08-13

Participant Flow

A total of 474 participants were screened for study eligibility at multiple sites in the United States and Europe. Screen failure was mostly due to inclusion/exclusion criteria not met and "other" reasons. The majority of participants (221/367) were enrolled at study sites in the United States.

A total of 474 participants were screened. 367 participants randomized in 1:1:1 ratio to 1 of 3 treatment groups. 5 randomized participants were not treated (2 in placebo + TCS group \& 3 in combined dupilumab + TCS group). Participants randomized to receive Dupilumab 100 mg or 200 mg Q2W + TCS, Dupilumab 300 mg Q4W + TCS or matching placebo.

Participant milestones

Participant milestones
Measure	Placebo + TCS Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Overall Study STARTED	123	122	122
Overall Study Completed Week 16 Study Treatment	114	118	119
Overall Study Completed Week 28 End of Study	0	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	123	122	122

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo + TCS Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Overall Study Transition to another study at week 16	80	86	78
Overall Study Transition to OLE during follow-up	37	33	39
Overall Study Physician Decision	0	1	1
Overall Study Withdrawal by Subject	5	1	2
Overall Study Other	1	1	1
Overall Study Ongoing	0	0	1

Baseline Characteristics

Here "number analyzed" represents the number of participants who were evaluable for this measure.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.	Total n=367 Participants Total of all reporting groups
Age, Continuous	8.3 years STANDARD_DEVIATION 1.76 • n=123 Participants	8.5 years STANDARD_DEVIATION 1.74 • n=122 Participants	8.5 years STANDARD_DEVIATION 1.68 • n=122 Participants	8.5 years STANDARD_DEVIATION 1.72 • n=367 Participants
Sex: Female, Male Female	62 Participants n=123 Participants	65 Participants n=122 Participants	57 Participants n=122 Participants	184 Participants n=367 Participants
Sex: Female, Male Male	61 Participants n=123 Participants	57 Participants n=122 Participants	65 Participants n=122 Participants	183 Participants n=367 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=123 Participants	16 Participants n=122 Participants	16 Participants n=122 Participants	45 Participants n=367 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	110 Participants n=123 Participants	106 Participants n=122 Participants	106 Participants n=122 Participants	322 Participants n=367 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=123 Participants	0 Participants n=122 Participants	0 Participants n=122 Participants	0 Participants n=367 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=123 Participants	0 Participants n=122 Participants	0 Participants n=122 Participants	0 Participants n=367 Participants
Race (NIH/OMB) Asian	13 Participants n=123 Participants	5 Participants n=122 Participants	10 Participants n=122 Participants	28 Participants n=367 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=123 Participants	0 Participants n=122 Participants	0 Participants n=122 Participants	0 Participants n=367 Participants
Race (NIH/OMB) Black or African American	23 Participants n=123 Participants	19 Participants n=122 Participants	20 Participants n=122 Participants	62 Participants n=367 Participants
Race (NIH/OMB) White	77 Participants n=123 Participants	89 Participants n=122 Participants	88 Participants n=122 Participants	254 Participants n=367 Participants
Race (NIH/OMB) More than one race	0 Participants n=123 Participants	0 Participants n=122 Participants	0 Participants n=122 Participants	0 Participants n=367 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=123 Participants	9 Participants n=122 Participants	4 Participants n=122 Participants	23 Participants n=367 Participants
Eczema Area and Severity Index (EASI) Score	39.0 Score on a Scale STANDARD_DEVIATION 12.01 • n=123 Participants	37.4 Score on a Scale STANDARD_DEVIATION 12.45 • n=122 Participants	37.3 Score on a Scale STANDARD_DEVIATION 10.86 • n=122 Participants	37.9 Score on a Scale STANDARD_DEVIATION 11.79 • n=367 Participants
Investigator's Global Assessment (IGA) Score	4.0 Score on a Scale STANDARD_DEVIATION 0.00 • n=123 Participants	4.0 Score on a Scale STANDARD_DEVIATION 0.09 • n=122 Participants	4.0 Score on a Scale STANDARD_DEVIATION 0.00 • n=122 Participants	4.0 Score on a Scale STANDARD_DEVIATION 0.05 • n=367 Participants
Weekly Average of Daily Worst Itch Score	7.7 Score on a Scale STANDARD_DEVIATION 1.54 • n=123 Participants • Here "number analyzed" represents the number of participants who were evaluable for this measure.	7.8 Score on a Scale STANDARD_DEVIATION 1.58 • n=122 Participants • Here "number analyzed" represents the number of participants who were evaluable for this measure.	7.8 Score on a Scale STANDARD_DEVIATION 1.52 • n=120 Participants • Here "number analyzed" represents the number of participants who were evaluable for this measure.	7.8 Score on a Scale STANDARD_DEVIATION 1.54 • n=365 Participants • Here "number analyzed" represents the number of participants who were evaluable for this measure.
Body Surface Area (BSA) of Atopic Dermatitis	60.2 Percentage of BSA STANDARD_DEVIATION 21.46 • n=123 Participants	54.8 Percentage of BSA STANDARD_DEVIATION 21.58 • n=122 Participants	57.8 Percentage of BSA STANDARD_DEVIATION 20.04 • n=122 Participants	57.6 Percentage of BSA STANDARD_DEVIATION 21.10 • n=367 Participants
SCORing Atopic Dermatitis (SCORAD) Score	72.9 Score on a Scale STANDARD_DEVIATION 12.01 • n=123 Participants	75.6 Score on a Scale STANDARD_DEVIATION 11.71 • n=122 Participants	72.3 Score on a Scale STANDARD_DEVIATION 10.83 • n=122 Participants	73.6 Score on a Scale STANDARD_DEVIATION 11.59 • n=367 Participants
Patient Oriented Eczema Measure (POEM)	20.7 Score on a Scale STANDARD_DEVIATION 5.48 • n=123 Participants	21.3 Score on a Scale STANDARD_DEVIATION 5.51 • n=122 Participants	20.5 Score on a Scale STANDARD_DEVIATION 5.50 • n=122 Participants	20.9 Score on a Scale STANDARD_DEVIATION 5.49 • n=367 Participants
Children's Dermatology Life Quality Index (CDLQI) Total Score	14.6 Score on a Scale STANDARD_DEVIATION 7.41 • n=123 Participants	16.2 Score on a Scale STANDARD_DEVIATION 7.85 • n=122 Participants	14.5 Score on a Scale STANDARD_DEVIATION 6.78 • n=122 Participants	15.1 Score on a Scale STANDARD_DEVIATION 7.38 • n=367 Participants
Dermatitis Family Index (DFI)	15.0 Score on a Scale STANDARD_DEVIATION 7.54 • n=123 Participants	16.9 Score on a Scale STANDARD_DEVIATION 8.65 • n=122 Participants	14.9 Score on a Scale STANDARD_DEVIATION 7.05 • n=122 Participants	15.6 Score on a Scale STANDARD_DEVIATION 7.81 • n=367 Participants
Patient Reported Outcomes Measurements Information Systems (PROMIS) Anxiety Scale	57.3 Score on a Scale STANDARD_DEVIATION 11.62 • n=121 Participants • Here number analyzed represents the number of participants who were evaluable for this measure.	59.8 Score on a Scale STANDARD_DEVIATION 13.66 • n=121 Participants • Here number analyzed represents the number of participants who were evaluable for this measure.	58.6 Score on a Scale STANDARD_DEVIATION 11.32 • n=121 Participants • Here number analyzed represents the number of participants who were evaluable for this measure.	58.6 Score on a Scale STANDARD_DEVIATION 12.25 • n=363 Participants • Here number analyzed represents the number of participants who were evaluable for this measure.
Patient Reported Outcomes Measurements Information Systems (PROMIS) Depression Scale	55.0 Score on a Scale STANDARD_DEVIATION 12.05 • n=121 Participants • Here number analyzed represents the number of participants who were evaluable for this measure.	58.1 Score on a Scale STANDARD_DEVIATION 12.77 • n=121 Participants • Here number analyzed represents the number of participants who were evaluable for this measure.	56.3 Score on a Scale STANDARD_DEVIATION 11.22 • n=121 Participants • Here number analyzed represents the number of participants who were evaluable for this measure.	56.4 Score on a Scale STANDARD_DEVIATION 12.06 • n=363 Participants • Here number analyzed represents the number of participants who were evaluable for this measure.

PRIMARY outcome

Timeframe: Week 16

The IGA was an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe). The full analysis set (FAS) included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Values after first rescue treatment used were set to missing. Participants with missing score at Week 16 were considered as a non-responder.

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 at Week 16	11.4 Percentage of Participants	32.8 Percentage of Participants	29.5 Percentage of Participants

SECONDARY outcome

Timeframe: Week 16

The EASI assesses severity and extent of atopic dermatitis (AD). Scores range from 0-72. Four AD disease characteristics (erythema, thickness, scratching, and lichenification) were assessed for severity on a scale of "0" (absent) through "3" (severe). Area of involvement assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder.

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Percentage of Participants With Eczema Area and Severity Index -75 (EASI-75) (≥ 75 Percent (%) Improvement From Baseline) at Week 16	26.8 Percentage of Participants	69.7 Percentage of Participants	67.2 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 16

The EASI assesses severity and extent of AD. Scores range from 0-72. Four AD disease characteristics (erythema, thickness, scratching, and lichenification) were assessed for severity on a scale of "0" (absent) through "3" (severe). Area of involvement assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16	-48.6 Percent change Standard Error 2.46 • Interval 2.46 to	-82.1 Percent change Standard Error 2.37 • Interval 2.37 to	-78.4 Percent change Standard Error 2.35 • Interval 2.35 to

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 16

The worst itch scale was a simple assessment tool that participants used to report the intensity of their pruritus (itch). This was an 11-point scale (0 to 10) in which 0 indicated no itching while 10 indicated worst itching possible. Participants were asked to answer 2 questions daily throughout the entire study (screening period, treatment period, and follow-up period). The daily worst itch score was calculated as the worse of the scores for the 2 questions. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Percent Change From Baseline in Weekly Average of Daily Worst Itch Score at Week 16	-25.9 Percent change Standard Error 2.90 • Interval 2.9 to	-54.6 Percent change Standard Error 2.89 • Interval 2.89 to	-57.0 Percent change Standard Error 2.77 • Interval 2.77 to

SECONDARY outcome

Timeframe: Week 16

The worst itch scale was a simple assessment tool that participants used to report the intensity of their pruritus (itch). This was an 11-point scale (0 to 10) in which 0 indicated no itching while 10 indicated worst itching possible. Participants were asked to answer 2 questions daily throughout the entire study (screening period, treatment period, and follow-up period). The daily worst itch score was calculated as the worse of the scores for the 2 questions. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder. Here "Number of participants analyzed" = number of participants who were evaluated for this specific endpoint.

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=121 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=120 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Itch Score ≥3 Points at Week 16	21.1 Percentage of Participants	60.3 Percentage of Participants	67.5 Percentage of Participants

SECONDARY outcome

Timeframe: Week 16

The worst itch scale was a simple assessment tool that participants used to report the intensity of their pruritus (itch). This was an 11-point scale (0 to 10) in which 0 indicated no itching while 10 indicated worst itching possible. Participants were asked to answer 2 questions daily throughout the entire study (screening period, treatment period, and follow-up period). The daily worst itch score was calculated as the worse of the scores for the 2 questions. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder. Here "Number of participants analyzed" = number of participants who were evaluated for this specific endpoint.

Outcome measures

Outcome measures
Measure	Placebo + TCS n=122 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=120 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=120 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Itch Score ≥4 Points at Week 16	12.3 Percentage of Participants	50.8 Percentage of Participants	58.3 Percentage of Participants

SECONDARY outcome

Timeframe: Week 16

The EASI assessed severity and extent of AD. Scores range from 0-72. Four AD disease characteristics (erythema, thickness, scratching, and lichenification) were assessed for severity on a scale of "0" (absent) through "3" (severe). Area of involvement assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder.

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Percentage of Participants Achieving Eczema Area and Severity Index - 50 (EASI-50) (≥ 50% Improvement From Baseline) at Week 16	43.1 Percentage of Participants	91.0 Percentage of Participants	82.8 Percentage of Participants

SECONDARY outcome

Timeframe: Week 16

The EASI assessed the severity and extent of atopic dermatitis (AD). Scores range from 0-72. Four AD disease characteristics (erythema, thickness, scratching, and lichenification) were assessed for severity on a scale of "0" (absent) through "3" (severe). Area of involvement assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder.

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Percentage of Participants Achieving Eczema Area and Severity Index - 90 (EASI - 90) (≥ 90% Improvement From Baseline) at Week 16	7.3 Percentage of Participants	41.8 Percentage of Participants	30.3 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 16

The worst itch scale: simple assessment tool that participants used to report intensity of their pruritus (itch). This was an 11-point scale (0 to 10) where 0 (no itching) and 10 (worst itching) possible. Participants were asked to answer 2 questions daily throughout the entire study (screening period, treatment period, \& follow-up period). The daily worst itch score was calculated as worse of scores for 2 questions. FAS was used. Time to event is calculated in weeks as (date of first event - date of first dose)/7. The event of NRS reduction ≥ 4 was based on observed data without setting data to be non-responder after rescue treatment use. Here "Number of participants analyzed" = number of participants who were evaluated for this specific endpoint \& "NA" represents "Not computable" as only 12.3% of participants achieved NRS reduction during 16-week treatment period \& hence median time to achieve ≥ 4-point reduction of NRS for placebo +TCS treated participants could not be reported.

Outcome measures

Outcome measures
Measure	Placebo + TCS n=122 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=120 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=120 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Time to Achieve ≥ 4 Point Reduction of Weekly Average of Daily Worst Itch Score From Baseline During the 16-week Treatment Period	NA Weeks NA represents "Not computable" as only 12.3% of participants achieved NRS reduction during 16-week treatment period \& hence median time to achieve ≥ 4-point reduction of NRS for placebo +TCS treated participants could not be reported.	10.0 Weeks Interval 7.0 to 13.0	10.0 Weeks Interval 8.0 to 12.0

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 16

The worst itch scale: a simple assessment tool that participants used to report intensity of their pruritus (itch). This was an 11-point scale (0 to 10) where 0 (no itching) \& 10 (worst itching) possible. Participants were asked to answer 2 questions daily throughout the entire study (screening period, treatment period, \& follow-up period). Daily worst itch score was calculated as worse of scores for 2 questions. FAS was used. Time to event is calculated in weeks as (date of first event - date of first dose)/7. The event of NRS reduction ≥ 3 was based on observed data without setting data to be non-responder after rescue treatment use. Here "Number of participants analyzed" = number of participants who were evaluated for this specific endpoint \& "NA" represents "Not computable" as only 21.1% of participants achieved NRS reduction during 16-week treatment period \& hence median time to achieve ≥ 3-point reduction of NRS for placebo +TCS treated participants could not be reported.

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=121 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=120 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Time to Achieve ≥ 3 Point Reduction of Weekly Average of Daily Worst Itch Score From Baseline During the 16-week Treatment Period	NA Weeks Interval 11.0 to NA represents "Not computable" as only 21.1% of participants achieved NRS reduction during 16-week treatment period \& hence median time to achieve ≥ 3-point reduction of NRS for placebo +TCS treated participants could not be reported.	6.0 Weeks Interval 5.0 to 9.0	5.0 Weeks Interval 5.0 to 7.0

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 16

BSA affected by AD was assessed for each section of the body using the rule of nines (the possible highest score for each region is: head and neck \[9%\], anterior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]) and were reported as a percentage of all major body sections combined. The proportion assigned to different body regions were different in younger children as compared to older children (head and neck area is assigned a higher proportion in younger children as compared to older children). The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 16	-21.65 Percentage of BSA Standard Error 1.721 • Interval 1.721 to	-40.53 Percentage of BSA Standard Error 1.648 • Interval 1.648 to	-39.37 Percentage of BSA Standard Error 1.629 • Interval 1.629 to

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 16

SCORAD was used to assess the extent and severity of AD. Extent and severity of eczema as well as subjective symptoms (insomnia, etc) were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease). The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16	-29.8 Percent change Standard Error 2.26 • Interval 2.26 to	-62.4 Percent change Standard Error 2.13 • Interval 2.13 to	-60.2 Percent change Standard Error 2.11 • Interval 2.11 to

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 16

CDLQI was a validated 10 question tool to measure the impact of skin disease on the quality of life (QOL) in children by assessing how much the skin problem has affected the participant over the past week. Nine questions were scored as follows: Very much = 3, Quite a lot = 2, Only a little = 1, Not at all or unanswered = 0. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question (maximum = 30, minimum = 0). Higher the score, the greater the impact on QOL. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Data presented reflects the mean \& standard deviation of the CDLQI total scores.

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16	-6.4 Score on a Scale Standard Error 0.51 • Interval 0.51 to	-10.6 Score on a Scale Standard Error 0.47 • Interval 0.47 to	-10.7 Score on a Scale Standard Error 0.46 • Interval 0.46 to

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 16

POEM was a 7-item, validated questionnaire used to assess disease symptoms in children and adults. The format was a response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on frequency of these disease symptoms during the past week (ie, 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days) with a scoring system of 0 to 28; the total score reflected the disease-related morbidity. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). A high score is indicative of a poor quality of life.

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16	-5.3 Score on a Scale Standard Error 0.69 • Interval 0.69 to	-13.6 Score on a Scale Standard Error 0.65 • Interval 0.65 to	-13.4 Score on a Scale Standard Error 0.65 • Interval 0.65 to

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 16

The worst itch scale was a simple assessment tool that participants used to report the intensity of their pruritus (itch). This was an 11-point scale (0 to 10) in which 0 indicated no itching while 10 indicated worst itching possible. Participants were asked to answer 2 questions daily throughout the entire study (screening period, treatment period, and follow-up period). The daily worst itch score was calculated as the worse of the scores for the 2 questions. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Change From Baseline in Weekly Average of Daily Worst Itch Score at Week 16	-2.05 Score on a Scale Standard Error 0.215 • Interval 0.215 to	-4.22 Score on a Scale Standard Error 0.207 • Interval 0.207 to	-4.45 Score on a Scale Standard Error 0.206 • Interval 0.206 to

SECONDARY outcome

Timeframe: Baseline (Day 1) , Week 16

DFI was a 10-item questionnaire with items inquiring about housework, food preparation, sleep, family leisure activity, shopping, expenditure, tiredness, emotional distress, relationships and the impact of helping with treatment on the primary caregiver's life. The DFI questions were scored on a four-point Likert scale ranging from 0 to 3, so that the total DFI score ranges from 0 to 30. Timeframe of reference was the past week. A higher DFI score indicated greater impairment in family Quality of life (QOL) as affected by atopic dermatitis. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Change From Baseline in Dermatitis Family Index (DFI) at Week 16	-6.77 Score on a Scale Standard Error 0.497 • Interval 0.497 to	-10.75 Score on a Scale Standard Error 0.476 • Interval 0.476 to	-10.89 Score on a Scale Standard Error 0.469 • Interval 0.469 to

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 16

Population: The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

PROMIS Anxiety instrument measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), \& somatic symptoms related to arousal (racing heart, dizziness). Each question has 5 response options ranging in value from 1-5 (1=Never, 2=Almost never, 3=Sometimes, 4=Often, 5=Almost Always). Total raw score calculated using sum of response values: for 8-item form, lowest possible is 8 \& highest possible is 40; For 6-item form: lowest possible is 6; highest possible is 30. Higher score indicates greater severity of symptoms.

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Change From Baseline in Patient Reported Outcomes Measurements Information Systems (PROMIS) Pediatric Anxiety Short Form Scale Total Score at Week 16	-10.17 Score on a Scale Standard Error 0.912 • Interval 0.912 to	-13.19 Score on a Scale Standard Error 0.861 • Interval 0.861 to	-13.54 Score on a Scale Standard Error 0.860 • Interval 0.86 to

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 16

Population: The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

PROMIS Depression instrument assesses self-reported negative mood (sadness/guilt), views of self (self-criticism/worthlessness) \& social cognition (loneliness/interpersonal alienation), \& decreased positive affect \& engagement (loss of interest/meaning/purpose). Each question has 5 response options with values from 1-5 (1=Never, 2=Almost never, 3=Sometimes, 4=Often, 5=Almost Always). Total raw score is the sum of response values. For 8-item form, lowest possible is 8, highest is 40; for 6-item form, lowest possible is 6, highest is 30. Higher score indicates greater severity of symptoms.

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Change From Baseline in Patient Reported Outcomes Measurements Information Systems (PROMIS) Pediatric Depressive Symptoms Short Form Scale Score at Week 16	-7.42 Score on a Scale Standard Error 0.848 • Interval 0.848 to	-12.84 Score on a Scale Standard Error 0.793 • Interval 0.793 to	-11.92 Score on a Scale Standard Error 0.790 • Interval 0.79 to

SECONDARY outcome

Timeframe: Baseline through Week 16

Treatment-emergent adverse events (TEAEs) were defined as adverse events (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. 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-subjects 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. Percentage of participants having at least one skin infection TEAE (Excluding Herpetic Infections) through Week 16 were reported. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Percentage of Participants Having at Least One Skin Infection Treatment Emergent Adverse Event (TEAE) (Excluding Herpetic Infections) Through Week 16	13.0 Percentage of Participants	5.7 Percentage of Participants	8.2 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) through Week 16

Treatment-emergent adverse events (TEAEs) were defined as adverse events (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. 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-participants 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. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Percentage of Participants Having at Least One Serious Treatment Emergent Adverse Event (TEAE) Through Week 16	1.6 Percentage of Participants	1.6 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 16

Proportion of TCS medication-free days is calculated as the number of days that a participant used neither TCS/TCI nor system rescue therapy divided by the study days of each period. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Here "Number of participants analyzed" = number of participants who were evaluated for this specific endpoint.

Outcome measures

Outcome measures
Measure	Placebo + TCS n=123 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=122 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=121 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Proportion of Topical Corticosteroid (TCS) Medication-free Days From Baseline to Week 16	0.11 Proportion of Days Standard Deviation 0.185 • Interval 0.185 to	0.20 Proportion of Days Standard Deviation 0.230 • Interval 0.23 to	0.19 Proportion of Days Standard Deviation 0.207 • Interval 0.207 to

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 16

Mean weekly dose of TCS in grams for low or medium potency TCS from baseline to Week 16 were reported. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Here "Number of participants analyzed" = number of participants who were evaluated for this specific endpoint.

Outcome measures

Outcome measures
Measure	Placebo + TCS n=120 Participants Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=120 Participants Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=120 Participants Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Mean Weekly Dose of Topical Corticosteroid (TCS) in Grams for Low or Medium Potency TCS From Baseline to Week 16	20.1 Grams Standard Error 1.37 • Interval 1.37 to	15.0 Grams Standard Error 1.36 • Interval 1.36 to	14.4 Grams Standard Error 1.38 • Interval 1.38 to

Adverse Events

Placebo + TCS

Serious events: 2 serious events

Other events: 57 other events

Deaths: 0 deaths

Dupilumab 300 mg Q4W + TCS

Serious events: 3 serious events

Other events: 47 other events

Deaths: 0 deaths

Dupilumab 100 mg or 200 mg Q2W + TCS

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo + TCS n=120 participants at risk Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=120 participants at risk Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 participants at risk Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Immune system disorders Food allergy	0.00% 0/120 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	0.83% 1/120 • Number of events 1 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	0.00% 0/122 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.
Infections and infestations Urinary tract infection	0.00% 0/120 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	0.83% 1/120 • Number of events 1 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	0.00% 0/122 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.
Injury, poisoning and procedural complications Bone contusion	0.00% 0/120 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	0.83% 1/120 • Number of events 1 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	0.00% 0/122 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.
Respiratory, thoracic and mediastinal disorders Asthma	0.83% 1/120 • Number of events 1 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	0.00% 0/120 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	0.00% 0/122 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.83% 1/120 • Number of events 1 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	0.00% 0/120 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	0.00% 0/122 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.

Other adverse events

Other adverse events
Measure	Placebo + TCS n=120 participants at risk Participants received matching placebo every 2 weeks (Q2W) or every 4 weeks (Q4W) during the 16-week double-blind treatment phase. Matching placebo was administered concomitantly with topical corticosteroids (TCS), including doubling the amount of placebo on Day 1 to match the loading dose.	Dupilumab 300 mg Q4W + TCS n=120 participants at risk Participants received subcutaneous injections of 600 milligrams (mg) loading dose on Day 1, then 300 mg of Dupilumab every 4 weeks (Q4W) from Week 4 to Week 12. Topical corticosteroids (TCS) were administered concomitantly during the 16-week double-blind treatment phase.	Dupilumab 100 mg or 200 mg Q2W + TCS n=122 participants at risk Participants received subcutaneous injections of 100 milligrams (mg) or 200 mg of Dupilumab every 2 weeks (Q2W). For 100 mg Q2W treatment group, participants received a 200 mg loading dose on Day 1, then 100 mg Q2W from Week 2 to Week 14. For 200 mg Q2W treatment group, participants received a 400 mg loading dose on Day 1, then 200 mg Q2W from Week 2 to Week 14. Topical corticosteroids (TCS) were administered concomitantly in all groups during the 16-week double-blind treatment phase.
Gastrointestinal disorders Vomiting	6.7% 8/120 • Number of events 9 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	5.0% 6/120 • Number of events 7 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	4.9% 6/122 • Number of events 8 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.
General disorders Injection site erythema	1.7% 2/120 • Number of events 3 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	4.2% 5/120 • Number of events 5 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	5.7% 7/122 • Number of events 9 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.
Infections and infestations Conjunctivitis	2.5% 3/120 • Number of events 3 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	4.2% 5/120 • Number of events 5 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	5.7% 7/122 • Number of events 8 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.
Infections and infestations Nasopharyngitis	6.7% 8/120 • Number of events 11 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	12.5% 15/120 • Number of events 16 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	6.6% 8/122 • Number of events 10 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.
Infections and infestations Upper respiratory tract infection	10.0% 12/120 • Number of events 12 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	11.7% 14/120 • Number of events 19 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	9.8% 12/122 • Number of events 16 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.
Infections and infestations Viral upper respiratory tract infection	5.0% 6/120 • Number of events 6 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	1.7% 2/120 • Number of events 2 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	0.82% 1/122 • Number of events 1 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.
Nervous system disorders Headache	8.3% 10/120 • Number of events 11 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	5.0% 6/120 • Number of events 7 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	5.7% 7/122 • Number of events 10 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.
Respiratory, thoracic and mediastinal disorders Asthma	9.2% 11/120 • Number of events 12 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	1.7% 2/120 • Number of events 2 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	3.3% 4/122 • Number of events 4 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.
Respiratory, thoracic and mediastinal disorders Cough	7.5% 9/120 • Number of events 13 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	2.5% 3/120 • Number of events 3 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	4.1% 5/122 • Number of events 5 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.
Skin and subcutaneous tissue disorders Dermatitis atopic	14.2% 17/120 • Number of events 25 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	6.7% 8/120 • Number of events 12 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.	8.2% 10/122 • Number of events 10 • Reported AEs are treatment-emergent adverse events which were collected for both the 16-week treatment period and the follow-up period for as long as 12 weeks. The safety analysis set (SAF) includes all randomized subjects who received at least one injection of study drug and were analyzed as treated. Treatment compliance/administration and all clinical safety variables were summarized based on the SAF.

Additional Information

Clinical Trial Administrator

Regeneron Pharmaceuticals, Inc.

Phone: 844-734-6643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER