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

Study acronym: MADULO
StatusCompleted
PhasePhase 4
Started2023-03-08
View on ClinicalTrials.gov ↗

Amendment history

2026-09-25
Trial completed
2025-09-10
Recruiting→Active, Not Recruiting Study Status, Oversight, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-12-08→2026-09-08
Completion date2026-12-08→2026-09-08
Study sitesdetails revised at 32 of 32 sites
2025-01-16
Study Status, Contacts/Locations v9
Primary completion date2026-03-08→2026-12-08
Completion date2026-03-08→2026-12-08
Study sites31→32
2024-03-28
Study Status, Contacts/Locations v8
Study sitesdetails revised at 3 of 31 sites
2024-01-29
Study Status, Contacts/Locations v7
Study sites29→31
Show 6 earlier versions
2023-12-18
Study Status, Contacts/Locations v6
Study sitesdetails revised at 5 of 29 sites
2023-10-16
Study Status, Contacts/Locations v5
Study sitesdetails revised at 4 of 29 sites
2023-07-10
Study Status, Contacts/Locations v4
Study sitesdetails revised at 14 of 29 sites
2023-05-15
Study Status, Contacts/Locations v3
Study sitesdetails revised at 12 of 29 sites
2023-03-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-03-01→2026-03-08
Completion date2026-03-01→2026-03-08
Start dateestimated 2023-03-01→confirmed 2023-03-08
Study sitesdetails revised at 29 of 29 sites
2022-12-08
Study Status, Outcome Measures v1
Secondary endpointsdetails revised at 1 of 6 entries
2022-12-07
Original filing
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.
Trial Details
NCT Number NCT05642208
Lead Sponsor Nantes University Hospital
Conditions Atopic Dermatitis, Eczema, Atopic
Enrollment 256 participants
Start Date 2023-03-08
Primary Completion 2026-08-27 (estimated)
Study Completion 2026-08-27 (estimated)
Updated on ClinicalTrials.gov 2026-09-24