Dupilumab step-down strategy to maintain remission in adult and adolescents patients with atopic dermatitis: a non-inferiority randomized trial
- Conditions
- atopic dermatitisMedDRA version: 21.1Level: LLTClassification code: 10003639Term: Atopic dermatitis Class: 10040785Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2022-501179-23-00
- Lead Sponsor
- Centre Hospitalier Universitaire De Nantes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 256
Age = 12 years, Moderate to severe AD treated with dupilumab every 2 weeks, Written informed consent (patient and/or person who has parental authority), Dupilumab treatment for at least one year, Controlled AD (ADCT<7 and IGA = 2) and assessed as controlled by the investigator since at least 6 months without tapering dosage of dupilumab, Amount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months and less than 60 g/month
Amount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months and less than 60 mg/month, Non controlled AD: ADCT = 7 or IGA = 3, Female patient must not be pregnant, breastfeeding or considering becoming pregnant, Patient under judicial protection, Adults under guardianship or trusteeship
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method