Dupilumab in Japanese Patients With Atopic Dermatitis

Sponsor
Sanofi
Study ID
NCT04678882
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)
  • Dupilumab SAR231893 — DRUG
    Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)

Study Details

Primary Objective: To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) Secondary Objective: To evaluate the efficacy of dupilumab administered concomitantly with TCS. To assess the safety of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in participants. To assess immunogenicity as determined by the incidence, titer, and clinical impact of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time in pediatric patients with atopic dermatitis (AD) (aged ≥6 months to \<18 years old) To assess the concentration of dupilumab in serum following administration concomitantly with TCS.

Key Dates

Start date
Jan 15, 2021
Status verified
Sep 2025
Primary completion
Dec 14, 2021
Completion
Oct 28, 2023

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab
    Double dose on day1 and followed by single dose every 2 weeks or single dose every 4 weeks
  • Placebo Comparator: Placebo
    Double dose on day1 and followed by single dose every 2 weeks or single dose every 4 weeks

Primary Outcome Measure

Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% improvement from baseline EASI) [ Time Frame: At Week 16 ]

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