NCT05642208 (MADULO) is a Phase 4 clinical trial of Dupilumab step-down in Atopic Dermatitis, sponsored by Nantes University Hospital.

Who is sponsoring NCT05642208?

NCT05642208 is sponsored by Nantes University Hospital.

What drugs are being tested in NCT05642208?

Interventions in NCT05642208: Dupilumab step-down.

What condition does NCT05642208 study?

NCT05642208 studies Atopic Dermatitis, Eczema, Atopic.

Is NCT05642208 still recruiting?

NCT05642208 is currently active, enrolled. Last updated 11 September 2025.

Last reviewed 2025-09-11 · How we verify

NCT05642208: MADULO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 4 Last updated 11 September 2025

What this trial tests

Phase 4 trial testing Dupilumab step-down in Atopic Dermatitis in 256 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 March 2023

Primary endpoint
8 September 2026

8 September 2026

Quick facts

Lead sponsor	Nantes University Hospital
Phase	Phase 4
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	256
Start date	8 March 2023
Primary completion	8 September 2026
Estimated completion	8 September 2026
Sites	32 locations across France, Reunion

Drugs / interventions tested

Dupilumab step-down — full drug profile →

Conditions studied

Atopic Dermatitis — all drugs for Atopic Dermatitis →
Eczema, Atopic — all drugs for Eczema, Atopic →

Sponsor

Nantes University Hospital

Who can join

12 and older, any sex, with Atopic Dermatitis or Eczema, Atopic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Advanced delivery of natural bioactive compounds for atopic dermatitis: a review of polymeric conjugates and nanocarriers.
Vyas J, Raytthatha N, Vyas P, Singh S, et al · · 2026 · PMID 41639533 · DOI 10.1007/s13659-025-00585-w
Dupilumab step-down strategy to maintain remission in adult and adolescent patients with atopic dermatitis: study protocol for a non-inferiority randomized trial (MADULO).
Foureau A, Faurel-Paul E, Hardouin JB, Papinot L, et al · · 2025 · PMID 41350756 · DOI 10.1186/s13063-025-09325-4
Dupilumab step-down strategy to maintain remission in adult and adolescent patients with atopic dermatitis: study protocol for a non-inferiority randomized trial (MADULO)
FOUREAU¹²³ A, FAUREL-PAUL⁴ E, HARDOUIN⁴ J, PAPINOT¹² L, et al · · 2025 · DOI 10.21203/rs.3.rs-5797626/v1

Verify or expand the search:

Other recruiting trials for Atopic Dermatitis

Currently open trials in the same condition.

NCT07262983 — Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopi · Phase 1 · recruiting
NCT07445919 — A Clinical Study to Evaluate SM17 for Atopic Dermatitis · Phase 2 · recruiting
NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants · Phase 1 · recruiting
NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit · recruiting
NCT07358156 — A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and E · Phase 1 · recruiting

Other Nantes University Hospital trials

Trials by the same sponsor.

NCT07278661 — Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. · Phase 2 · recruiting
NCT06681363 — Creation of a Biocollection of Patients With Acute Myeloid Leukemia (AML) or Lymphoid Leukemia (ALL) or High-risk Myelod · not yet recruiting
NCT07467382 — GOAT (Gait Observation of Achilles Tendon) · not yet recruiting
NCT07490379 — Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients Wi · NA · not yet recruiting
NCT07423481 — Weight Trajectories and Predictive Factors After Semaglutide in Patients With Grade 3 and Complicated Obesity · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05642208 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Nantes University Hospital
Last refreshed: 11 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05642208.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing