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Long-term OPA-15406 (Difamilast) in Adult and Pediatric Atopic Dermatitis
NCT03961529Phase 3
Key facts
- Status
- Completed
- Start
- May 2019
- Primary completion
- Nov 2020
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- difamilast
- Conditions
- atopic dermatitis (AD)
01
Overview
Phase 3, open-label trial of difamilast in atopic dermatitis (AD) (2 arms), sponsored by Otsuka Pharmaceutical Co., Ltd. Primary endpoint: Treatment-Emergent Adverse Events at 52 weeks. Started May 2019; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
0.3% OPA-15406
Pediatric patients receiving 0.3% OPA-15406 ointment twice daily
1% OPA-15406
Adult and pediatric patients receiving 1% OPA-15406 ointment twice daily
03
Who it enrols
Patients aged 2 years or older with a diagnosis of atopic dermatitis (AD) based on the Japanese Dermatological Association's criteria, affecting at least 5% of body surface area (excluding scalp). Patients with a recent flare-up (rapid intensification) within 28 days are excluded.
04
Endpoints
Primary
Treatment-Emergent Adverse Events
Secondary
Investigator's Global Assessment Response Rate
Eczema Area and Severity Index 75
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