Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis
MADULO
1 other identifier
interventional
256
2 countries
32
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2023
Longer than P75 for phase_4
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2022
CompletedFirst Posted
Study publicly available on registry
December 8, 2022
CompletedStudy Start
First participant enrolled
March 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 8, 2026
September 11, 2025
September 1, 2025
3.5 years
November 29, 2022
September 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the curve of Atopic Dermatitis Control Tool (ADCT)
to demonstrate the non-inferiority of a step down dosage strategy of dupilumab as compared with maintenance of initial treatment, on long-term control of the disease severity at one year in adolescents and adults patients with controlled AD.The primary endpoint is the Area under the curve of Atopic Dermatitis Control Tool (ADCT) score achieved by the patient every week during one year. As the ADCT score refers to the last 7 days, a weekly assessment is the most accurate to detect all variations in disease severity intensity.
over 12 months
Secondary Outcomes (6)
Mean difference in EASI score
every 4 months over 12 months
Mean difference in Investigator global assessment
every 4 months over 12 months
Mean difference in Itch numerical rating scale
every 4 months over 12 months
The patient quality of life will be assessed with the DLQI (Dermatology Life Quality Index) measured at M4, M8, M12 or with the CDLQI (Children Dermatology Life Quality Index) for children under 16. Mean difference in DLQI (CDLQI for children <16)
every 4 months over 12 months
cost-utility analysis performed from a health care system perspective
over 12 months
- +1 more secondary outcomes
Study Arms (2)
Experimental Group
EXPERIMENTALInjections will be spaced as : * Every 3 weeks between M0 and M4, * Every 4 weeks between M4 and M8 (if ADCT\<7 and IGA ≤ 2, AD assessed as controlled by the investigator and stable amount of local treatment used), * Then every 5 weeks until the end of the clinical trial (M12) (if ADCT\<7 and IGA ≤ 2, AD assessed as controlled by the investigator and stable amount of local treatment used). In case of ADCT≥7 or IGA \> 2 or disease assessed as uncontrolled by the investigator, the injection interval treatment will be step up to the previous interval. The treatment is administered subcutaneously and can be delivered in pen or syringe for subcutaneous injection. The dosage is usually : * 300 mg per injection for adults and adolescents (12-17 years) weighing more than 60 kg * 200 mg per injection for adolescents (12-17 years) weighing less than 60 kg.
Control group
NO INTERVENTIONin this group the interval between injections is maintained every 2 weeks (14 days) throughout the clinical trial. The treatment is administered subcutaneously and can be delivered in pen or syringe for subcutaneous injection. Treatment will be prescribed in the control group according to the marketing authorization dosage (see paragraph 5.1). The dosage is usually : * 300 mg every 14 days for adults and adolescents (12-17 years) weighing more than 60 kg * 200 mg every 14 days for adolescents (12-17 years) weighing less than 60 kg.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 12 years
- Moderate to severe AD treated with dupilumab every 2 weeks
- Written informed consent (patient and/or person who has parental authority)
- Dupilumab treatment for at least one year
- Controlled AD (ADCT\<7 and IGA ≤ 2) and assessed as controlled by the investigator since at least 6 months without tapering dosage of dupilumab
- Amount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months and less than 60 g/month
You may not qualify if:
- Patients with Side effects of dupilumab
- Non controlled AD: ADCT ≥ 7 or IGA ≥ 3
- Female patient must not be pregnant\*, breastfeeding or considering becoming pregnant
- Patient under judicial protection
- Adults under guardianship or trusteeship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Amiens University hospital
Amiens, France
CHU d'Angers
Angers, France
Hôpital Victor Dupouy
Argenteuil, France
CHU de Besançon
Besançon, France
CHU de Bordeaux Adulte
Bordeaux, France
CHRU de Brest
Brest, France
CHU de Clermont Ferrand
Clermont-Ferrand, France
CHU de Dijon
Dijon, France
CHU de Grenoble
Grenoble, France
CHD Vendée
La Roche-sur-Yon, France
GH La Rochelle - Ré-Aunis
La Rochelle, France
CH de Le Mans
Le Mans, France
CHRU de Lille
Lille, France
Groupement des Hôpitaux de l'institut Catholique de Lille
Lille, France
Hospices Civils de Lyon
Lyon, France
Hôpital de la Timone
Marseille, France
CHU de Montpellier
Montpellier, France
CHU de Nantes
Nantes, France
CH de Niort
Niort, France
Hôpital Cochin
Paris, France
Hôpital Necker-Enfants malades
Paris, France
Hôpital Saint Louis
Paris, France
Hôpital Tenon
Paris, France
CHU de Poitiers
Poitiers, France
CHU de Reims
Reims, France
CHU de Rennes
Rennes, France
CHU de Rouen
Rouen, France
CH de Saint Nazaire
Saint-Nazaire, France
HIA Sainte Anne
Toulon, France
CHU de Toulouse - Hôpital Larrey
Toulouse, France
CHRU de Tours
Tours, France
CHU de La Réunion
Saint-Pierre, La Réunion, Reunion
Related Publications (1)
Foureau A, Faurel-Paul E, Hardouin JB, Papinot L, Schirr-Bonnans S, Tessier P, Jobert A, Poinas A, Staumont-Salle D, Tauber M, Chosidow O, Barbarot S, Aubert H; the FRench Atopic DErmatitis Network from de GREAT Research group. Dupilumab step-down strategy to maintain remission in adult and adolescent patients with atopic dermatitis: study protocol for a non-inferiority randomized trial (MADULO). Trials. 2025 Dec 5;27(1):26. doi: 10.1186/s13063-025-09325-4.
PMID: 41350756DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hélène AUBERT
Nantes University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2022
First Posted
December 8, 2022
Study Start
March 8, 2023
Primary Completion (Estimated)
September 8, 2026
Study Completion (Estimated)
September 8, 2026
Last Updated
September 11, 2025
Record last verified: 2025-09