Informations générales (source: ClinicalTrials.gov)
Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis: a Non-inferiority Randomized Trial (MADULO)
Interventional
Phase 4
Nantes University Hospital (Voir sur ClinicalTrials)
mars 2023
décembre 2026
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Cochin | Marie-Noëlle CREPY | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Necker-Enfants Malades | Nathalia BELLON | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Tenon | Angèle SORIA | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Amiens University hospital - Amiens - France | Ali DADBI | Contact (sur clinicalTrials) | |||
| CH de Le Mans - Le Mans - France | Corina BARA-PASSOT | Contact (sur clinicalTrials) | |||
| CH de Niort - Niort - France | Ingrid KUPFER | Contact (sur clinicalTrials) | |||
| CH de Saint Nazaire - Saint-Nazaire - France | Sophie OSDOIT-MEDART | Contact (sur clinicalTrials) | |||
| CHD Vendée - La Roche-sur-Yon - France | Romain GABEFF | Contact (sur clinicalTrials) | |||
| CHRU de Brest - Brest - France | Laurent MISERY | Contact (sur clinicalTrials) | |||
| CHRU de Lille - Lille - France | Delphine STAUMONT-SALLE | Contact (sur clinicalTrials) | |||
| CHRU de Tours - Tours - France | Sophie LEDUCQ | Contact (sur clinicalTrials) | |||
| CHU d'Angers - Angers - France | Clémence BERTHIN | Contact (sur clinicalTrials) | |||
| CHU de Besançon - Besançon - France | François AUBIN | Contact (sur clinicalTrials) | |||
| CHU de Bordeaux Adulte - Bordeaux - France | Julien SENESCHAL | Contact (sur clinicalTrials) | |||
| CHU de Clermont Ferrand - Clermont-Ferrand - France | Justine PASTEUR | Contact (sur clinicalTrials) | |||
| CHU de Dijon - Dijon - France | Camille LELEU | Contact (sur clinicalTrials) | |||
| CHU de Grenoble - Grenoble - France | Pauline PRALONG | Contact (sur clinicalTrials) | |||
| CHU de Montpellier - Montpellier - France | Nadia RAISON | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Nantes - France | Hélène AUBERT | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - Poitiers - France | Ewa WIERZBICKA-HAINAUT | Contact (sur clinicalTrials) | |||
| CHU de Reims - Reims - France | Contact (sur clinicalTrials) | ||||
| CHU de Rennes - Rennes - France | Catherine DROITCOURT | Contact (sur clinicalTrials) | |||
| CHU de Rouen - Rouen - France | Florence TETART | Contact (sur clinicalTrials) | |||
| CHU de Toulouse - Hôpital Larrey - Toulouse - France | Juliette MAZEREEUW-HAUTIER | Contact (sur clinicalTrials) | |||
| GH La Rochelle - Ré-Aunis - La Rochelle - France | Cécile FRENARD, MD | Contact (sur clinicalTrials) | |||
| Groupement des Hôpitaux de l'institut Catholique de Lille - Lille - France | Contact (sur clinicalTrials) | ||||
| HIA Sainte Anne - Toulon - France | Aude VALOIS, MD | Contact (sur clinicalTrials) | |||
| Hôpital de la Timone - Marseille - France | Stéphanie MALLET | Contact (sur clinicalTrials) | |||
| Hôpital Saint Louis - Paris - France | Jean-David BOUAZIZ | Contact (sur clinicalTrials) | |||
| Hôpital Victor Dupouy - Argenteuil - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon - Lyon - France | Audrey NOSBAUM | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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