Trials / Completed
CompletedNCT04678882
Dupilumab in Japanese Patients With Atopic Dermatitis
A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Dupilumab Compared to Placebo in Japanese Patients With Atopic Dermatitis Aged 6 Months to <18 Years Whose Disease is Not Adequately Controlled With Existing Therapies
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 6 Months – 17 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC) |
| DRUG | Dupilumab SAR231893 | Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC) |
Timeline
- Start date
- 2021-01-15
- Primary completion
- 2021-12-14
- Completion
- 2023-10-28
- First posted
- 2020-12-22
- Last updated
- 2025-09-12
Locations
19 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT04678882. Inclusion in this directory is not an endorsement.