Overview

Dupilumab in Japanese Patients With Atopic Dermatitis

Status:
Active, not recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals