Trial Outcomes & Findings for A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema) (NCT NCT02407756)

Last Updated: 2020-11-27

Results Overview

Peak dupilumab concentration in serum following single dose administration. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

Day 2, 4, 8, 15, 22, 29, 36, 43, and 50

Results posted on

2020-11-27

Participant Flow

The study was conducted at 25 sites in 6 countries. A total of 88 participants were screened, and of those, 78 participants were randomized with 77 being treated. Ten participants were screen failures as 5 were due to exclusion criteria met \& inclusion criteria not met, 4 participants withdrew consent and 1 participant was lost to follow-up.

A total of 40 adolescents (aged ≥12 to \<18 years) and 38 children (aged ≥6 to \<12 years) were enrolled and randomized to 2 sequential ascending dose cohorts: Cohort 1 (2 mg/kg) and Cohort 2 (4 mg/kg).

Participant milestones

Participant milestones
Measure	Dupilumab 2mg/kg: Adolescents Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 2mg/kg: Children Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.	Dupilumab 4mg/kg: Adolescents Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 4mg/kg: Children Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.
Overall Study STARTED	20	18	20	19
Overall Study Treated	20	18	20	19
Overall Study COMPLETED	20	18	20	19
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dupilumab 2mg/kg: Adolescents n=20 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 2mg/kg: Children n=18 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.	Dupilumab 4mg/kg: Adolescents n=20 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 4mg/kg: Children n=19 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.	Total n=77 Participants Total of all reporting groups
Race Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Race White	17 Participants n=5 Participants	17 Participants n=7 Participants	15 Participants n=5 Participants	18 Participants n=4 Participants	67 Participants n=21 Participants
Age, Continuous	14.7 years STANDARD_DEVIATION 2.01 • n=5 Participants	8.2 years STANDARD_DEVIATION 1.62 • n=7 Participants	14.3 years STANDARD_DEVIATION 1.66 • n=5 Participants	8.2 years STANDARD_DEVIATION 1.99 • n=4 Participants	11.5 years STANDARD_DEVIATION 3.64 • n=21 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	8 Participants n=4 Participants	39 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	11 Participants n=4 Participants	38 Participants n=21 Participants
Ethnicity Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity Not Hispanic or Latino	20 Participants n=5 Participants	18 Participants n=7 Participants	20 Participants n=5 Participants	18 Participants n=4 Participants	76 Participants n=21 Participants
Race Other	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Number of Subjects with Investigator Global Assessment (IGA) score of 3 or 4 IGA score of 3	8 Participants n=5 Participants	1 Participants n=7 Participants	11 Participants n=5 Participants	0 Participants n=4 Participants	20 Participants n=21 Participants
Number of Subjects with Investigator Global Assessment (IGA) score of 3 or 4 IGA score of 4	12 Participants n=5 Participants	17 Participants n=7 Participants	9 Participants n=5 Participants	19 Participants n=4 Participants	57 Participants n=21 Participants
Eczema Area and Severity Index (EASI) score	34.8 Score on a scale STANDARD_DEVIATION 17 • n=5 Participants	32.9 Score on a scale STANDARD_DEVIATION 15.53 • n=7 Participants	28.6 Score on a scale STANDARD_DEVIATION 14.7 • n=5 Participants	38.8 Score on a scale STANDARD_DEVIATION 18.64 • n=4 Participants	33.7 Score on a scale STANDARD_DEVIATION 16.62 • n=21 Participants
Pruritus Numerical Rating Scale (NRS)	6.1 Score on a scale STANDARD_DEVIATION 2.47 • n=5 Participants	6.4 Score on a scale STANDARD_DEVIATION 2.23 • n=7 Participants	6.9 Score on a scale STANDARD_DEVIATION 2.21 • n=5 Participants	6.7 Score on a scale STANDARD_DEVIATION 2.35 • n=4 Participants	6.5 Score on a scale STANDARD_DEVIATION 2.29 • n=21 Participants
Body Surface Area (BSA) Involvement with Atopic Dermatitis (AD)	52.2 Percentage of body surface area STANDARD_DEVIATION 24.78 • n=5 Participants	59 Percentage of body surface area STANDARD_DEVIATION 22.49 • n=7 Participants	45.9 Percentage of body surface area STANDARD_DEVIATION 25.34 • n=5 Participants	62.3 Percentage of body surface area STANDARD_DEVIATION 30.34 • n=4 Participants	54.6 Percentage of body surface area STANDARD_DEVIATION 26.19 • n=21 Participants
SCORing Atopic Dermatitis (SCORAD) Score	68 Score on a scale STANDARD_DEVIATION 13.19 • n=5 Participants	66.4 Score on a scale STANDARD_DEVIATION 13.06 • n=7 Participants	63 Score on a scale STANDARD_DEVIATION 14.43 • n=5 Participants	72.7 Score on a scale STANDARD_DEVIATION 12.96 • n=4 Participants	67.5 Score on a scale STANDARD_DEVIATION 13.64 • n=21 Participants

PRIMARY outcome

Timeframe: Day 2, 4, 8, 15, 22, 29, 36, 43, and 50

Outcome measures

Outcome measures
Measure	Dupilumab 2mg/kg: Adolescents n=20 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 2mg/kg: Children n=18 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.	Dupilumab 4mg/kg: Adolescents n=20 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 4mg/kg: Children n=19 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.
Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration	9.91 mg/L Standard Deviation 2.15 • Interval 2.15 to	14.3 mg/L Standard Deviation 5.9 • Interval 5.9 to	23.1 mg/L Standard Deviation 8.71 • Interval 8.71 to	32.4 mg/L Standard Deviation 7.04 • Interval 7.04 to

PRIMARY outcome

Timeframe: Day 2, 4, 8, 15, 22, 29, 36, 43, and 50

Mean AUC estimates were calculated using mean concentration data at each time point, using a non-compartmental approach (NCA). Calculated AUClast (computed from time zero to the time of the last positive concentration) are presented. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.

Outcome measures

Outcome measures
Measure	Dupilumab 2mg/kg: Adolescents n=20 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 2mg/kg: Children n=18 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.	Dupilumab 4mg/kg: Adolescents n=20 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 4mg/kg: Children n=19 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.
PK of Dupilumab: Area Under the Plasma Concentration Versus Time Curve (AUClast) After Single Administration	104 Day*mg/L Standard Deviation NA Standard deviation is not available, as AUC was not calculated individually due to the sparse nature of the data collected per participant, rendering individual estimates inaccurate	160 Day*mg/L Standard Deviation NA Standard deviation is not available, as AUC was not calculated individually due to the sparse nature of the data collected per participant, rendering individual estimates inaccurate	362 Day*mg/L Standard Deviation NA Standard deviation is not available, as AUC was not calculated individually due to the sparse nature of the data collected per participant, rendering individual estimates inaccurate	330 Day*mg/L Standard Deviation NA Standard deviation is not available, as AUC was not calculated individually due to the sparse nature of the data collected per participant, rendering individual estimates inaccurate

PRIMARY outcome

Timeframe: Pre-dose on Day 71 and Day 85

Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of study drug.

Outcome measures

Outcome measures
Measure	Dupilumab 2mg/kg: Adolescents n=20 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 2mg/kg: Children n=18 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.	Dupilumab 4mg/kg: Adolescents n=20 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 4mg/kg: Children n=19 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.
PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose Day 71	10.4 mg/L Standard Deviation 7.16	17.2 mg/L Standard Deviation 8.44	32.8 mg/L Standard Deviation 18.9	42.1 mg/L Standard Deviation 19.4
PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose Day 85	18.5 mg/L Standard Deviation 12.4	28 mg/L Standard Deviation 12.9	58.8 mg/L Standard Deviation 24.4	60.3 mg/L Standard Deviation 36.3

SECONDARY outcome

Timeframe: Baseline to Week 12 (one week after last dose)

The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD. Analysis was performed on safety analysis set (SAF) that included all subjects who received any study drug. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by last observation carried forward (LOCF).

Outcome measures

Outcome measures
Measure	Dupilumab 2mg/kg: Adolescents n=20 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 2mg/kg: Children n=18 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.	Dupilumab 4mg/kg: Adolescents n=20 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 4mg/kg: Children n=19 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.
Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12	-66.4 percent change Standard Deviation 29.25 • Interval 29.25 to	-76.2 percent change Standard Deviation 25.48 • Interval 25.48 to	-69.7 percent change Standard Deviation 24.48 • Interval 24.48 to	-63.4 percent change Standard Deviation 25.37 • Interval 25.37 to

SECONDARY outcome

Timeframe: Baseline to Week 12 (one week after last dose)

SCORAD is a clinical tool for assessing the severity of atopic dermatitis 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 \[severe disease\]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Dupilumab 2mg/kg: Adolescents n=20 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 2mg/kg: Children n=18 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.	Dupilumab 4mg/kg: Adolescents n=20 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 4mg/kg: Children n=19 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.
Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12	-47.7 percent change Standard Deviation 27.27 • Interval 27.27 to	-57.5 percent change Standard Deviation 23.1 • Interval 23.1 to	-43.4 percent change Standard Deviation 25.38 • Interval 25.38 to	-46.9 percent change Standard Deviation 24.31 • Interval 24.31 to

SECONDARY outcome

Timeframe: Baseline to Week 12 (one week after last dose)

Pruritus NRS scale is an assessment tool that is used to report the intensity of subject's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Subjects were asked the following question: how would a subject rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Dupilumab 2mg/kg: Adolescents n=20 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 2mg/kg: Children n=18 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.	Dupilumab 4mg/kg: Adolescents n=20 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 4mg/kg: Children n=19 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.
Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12	-30.8 Percent change Standard Deviation 68.35 • Interval 68.35 to	-41.6 Percent change Standard Deviation 35.32 • Interval 35.32 to	-37.6 Percent change Standard Deviation 34.42 • Interval 34.42 to	-39.6 Percent change Standard Deviation 40.88 • Interval 40.88 to

SECONDARY outcome

Timeframe: Week 12

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). Analysis was performed on SAF. Subjects with rescue treatment usage during the Part B period were specified as non-responders from the time the rescue was used.

Outcome measures

Outcome measures
Measure	Dupilumab 2mg/kg: Adolescents n=20 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 2mg/kg: Children n=18 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.	Dupilumab 4mg/kg: Adolescents n=20 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 4mg/kg: Children n=19 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.
Percentage of Subjects With Investigator Global Assessment (IGA) Score of "0" or "1" (Clear or Almost Clear) at Week 12	10 Percentage of subjects	16.7 Percentage of subjects	35 Percentage of subjects	21.1 Percentage of subjects

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Here "Number of participants analyzed" = number of participants who were evaluated for this specific outcome measure.

Body surface area 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. Analysis was performed on SAF.

Outcome measures

Outcome measures
Measure	Dupilumab 2mg/kg: Adolescents n=19 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 2mg/kg: Children n=16 Participants Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.	Dupilumab 4mg/kg: Adolescents n=19 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 4mg/kg: Children n=19 Participants Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.
Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12	-61 Percentage of body surface area Standard Deviation 31.08 • Interval 31.08 to	-70 Percentage of body surface area Standard Deviation 31.93 • Interval 31.93 to	-60.4 Percentage of body surface area Standard Deviation 34.04 • Interval 34.04 to	-50 Percentage of body surface area Standard Deviation 30.8 • Interval 30.8 to

Adverse Events

Dupilumab 2mg/kg: Adolescents

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Dupilumab 2mg/kg: Children

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Dupilumab 4 mg/kg: Adolescents

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Dupilumab 4 mg/kg: Children

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dupilumab 2mg/kg: Adolescents n=20 participants at risk Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period, then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 2mg/kg: Children n=18 participants at risk Dupilumab 2 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period, then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.	Dupilumab 4 mg/kg: Adolescents n=20 participants at risk Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period, then 4 repeated doses weekly in subjects aged between ≥12 to \<18 years.	Dupilumab 4 mg/kg: Children n=19 participants at risk Dupilumab 4 mg/kg as a single dose on Day 1 followed by 8-week PK sampling period), then 4 repeated doses weekly in subjects aged between ≥6 to \<12 years.
Cardiac disorders Palpitations	5.0% 1/20 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	0.00% 0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	0.00% 0/19 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	0.00% 0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	5.3% 1/19 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.
Infections and infestations Staphylococcal skin infection	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	0.00% 0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	5.0% 1/20 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	0.00% 0/19 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.
Infections and infestations Arthritis bacterial	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	0.00% 0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	5.3% 1/19 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.
Infections and infestations Dermatitis infected	5.0% 1/20 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	0.00% 0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	5.0% 1/20 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.	5.3% 1/19 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Treatment Emergent Adverse Events (TEAEs) that developed/ worsened during the treatment and follow-up period (time period from the administration of first dose of study drug to End of Study (EOS) visit \[8 weeks after the last dose). Analysis was performed on SAF.

Other adverse events

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