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)

Conditions

• Dermatitis, Atopic

Eligibility Criteria

Sex

ALL

Age

6 Years - 11 Years

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG
  Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous (SC)
• Matching Placebo — DRUG
  Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)
• Background Treatment: Topical Corticosteroids — OTHER
  All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.
• Background Treatment: Moisturizers — OTHER
  All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.

Study Details

The main objective of the trial is to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in participants ≥6 years to \<12 years of age with severe atopic dermatitis (AD). The secondary objective is to assess the safety of dupilumab administered concomitantly with TCS in patients ≥6 years to \<12 years of age with severe AD.

Key Dates

Start date

Nov 17, 2017

Status verified

Jul 2020

Primary completion

Jun 20, 2019

Completion

Sep 10, 2019

Study Design

Enrollment

367 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1
  Participants will receive dupilumab, dosing regimen 1
• Experimental: Group 2
  Participants will receive dupilumab, dosing regimen 2
• Experimental: Group 3
  Participants will receive matching placebo

Primary Outcome Measure

Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 at Week 16 [ Time Frame: Week 16 ]

Locations (31)

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