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Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis — MADULO  

Atopic Dermatitis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

For both groups: At inclusion visit : - Patient information and signature of consent form - Randomisation - Previous medical history - Clinical exam - Recording ADCT, EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L Weekly during 12 months (by patients on https://hestia.chu-nantes.fr) : - Self-assessment of ADCT - Date of dupilumab injections - Batch number of dupilumab - Amount of topical corticosteroids Visits at M4, M8 and M12 will be performed for : - Clinical exam - Recording secondary end points (EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L) and adverse events - Collect out-of-pocket expenses (M4 and M12). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05642208
Study type Interventional
Source Nantes University Hospital
Contact Elodie FAUREL-PAUL
Phone +33 (0) 2 44 76 81 44
Email Elodie.FAURELPAUL@chu-nantes.fr
Status Recruiting
Phase Phase 4
Start date March 8, 2023
Completion date March 8, 2026
View Details
See also
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