Dupilumab in Japanese Patients With Atopic Dermatitis

Status Completed

Clinical Trial 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.

Clinical Trial Description

For participant who declines to enter open-lebal extension (OLE), the duration of the study for each participant is approximately 33 weeks (including screening and follow-up) For participant choosing enter OLE, the duration is approximately 21 weeks (including screening) plus 3 years OLE period or until approval of the indication in Japan whichever is sooner. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04678882
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 3
Start date	January 15, 2021
Completion date	October 28, 2023

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See also
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