Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis: a Non-inferiority Randomized Trial

RC22_0378

The goal of this clinical trial is to compare a step-down strategy of spacing dupilumab injections with a standard maintenance treatment in adolescents and adults with controlled Atopic dermatitis (AD) for at least six months. The impact of dosage reduction strategies will be assessed with an innovative primary endpoint: the area under the curve of the weekly ADCT assessment.

2023-03-08

2026-03-08

2026-03-08

Recruiting

Early phase I

256

Inclusion Criteria: * 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 Exclusion Criteria: * Patients with Side effects of dupilumab * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 256, 'type': 'ESTIMATED'}}

2024-03-29