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NCT05642208
Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis
Conditions: Atopic Dermatitis, Eczema, Atopic
Sex: All
Ages: 12 Years – N/A
Phase: PHASE4
Enrollment: 256
Sponsor: Nantes University Hospital
Location: France
Summary
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.
Eligibility Criteria
Inclusion Criteria:Age ≥ 12 yearsModerate to severe AD treated with dupilumab every 2 weeksWritten informed consent (patient and/or person who has parental authority)Dupilumab treatment for at least one yearControlled AD (ADCT<7 and IGA ≤ 2) and assessed as controlled by the investigator since at least 6 months without tapering dosage of dupilumabAmount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months and less than 60 g/monthExclusion Criteria:Patients with Side effects of dupilumabNon controlled AD: ADCT ≥ 7 or IGA ≥ 3Female patient must not be pregnant*, breastfeeding or considering becoming pregnantPatient under judicial protectionAdults under guardianship or trusteeship
Source: ClinicalTrials.gov (NCT05642208). StuddyBuddy aggregates publicly available trial information.