Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis

Sponsor
Sanofi
Study ID
NCT03912259
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Pharmaceutical form: solution, Route of administration: SC
  • Placebo — DRUG
    Pharmaceutical form: solution, Route of administration: SC
  • Emollient (moisturizer) — DRUG
    Pharmaceutical form: cream, Route of administration: topical use

Study Details

Primary Objective: To evaluate the efficacy of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe atopic dermatitis (AD). Secondary Objectives: * To evaluate the safety of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe AD. * To evaluate the effect of dupilumab on improving patient reported outcomes (PROs). * To evaluate dupilumab immunogenicity.

Key Dates

Start date
Dec 19, 2018
Status verified
Dec 2023
Primary completion
Feb 14, 2020
Completion
Feb 14, 2020

Study Design

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

Arms

  • Placebo Comparator: Placebo Q2W
    Placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (Q2W) for 16 weeks.
  • Experimental: Dupilumab 300 mg Q2W
    Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.

Primary Outcome Measure

Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of Greater Than or Equal to (>=) 2 Points at Week 16 [ Time Frame: Baseline, Week 16 ]

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