NCT05642208

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Atopic Dermatitis
• Eczema, Atopic

Interventions

Type	Name	Description
DRUG	Dupilumab step-down	step down dupilumab injections

Timeline

• Start date: 2023-03-08
• Primary completion: 2026-09-08
• Completion: 2026-09-08
• First posted: 2022-12-08
• Last updated: 2025-09-11

Locations

32 sites across 2 countries: France, Reunion