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CompletedPhase 4

Dupilumab step-down strategy to maintain remission in adult and adolescents patients with atopic dermatitis: a non-inferiority randomized trial

Key facts

Where
Amiens Cedex 1, Angers, Besancon Cedex, Bordeaux, Brest, Clermont-Ferrand, Dijon, Grenoble Cedex 9, La Roche Sur Yon Cedex 9, La Rochelle, Le Mans Cedex 9, Lille, Lyon Cedex 02, Marseille, Montpellier Cedex 5, Nantes Cedex 1, Niort, Paris, Poitiers, Rennes Cedex 9, Rouen Cedex, Saint Nazaire Cedex, Saint-Denis, Toulon Cedex 9, Toulouse, and Tours, FranceSee the 28 sites
Phase
Phase 4

Where in France

  • Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranceNo longer taking part
  • Centre Hospitalier Regional D'AngersAngers, FranceNo longer taking part
  • Besancon University Hospital CenterBesancon Cedex, FranceNo longer taking part
  • Centre hospitalier Universitaire de BordeauxBordeaux, FranceNo longer taking part
  • Centre Hospitalier Régional et Universitaire de BrestBrest, FranceNo longer taking part
  • University Hospital Of Clermont-FerrandClermont-Ferrand, FranceNo longer taking part
  • Centre Hospitalier Universitaire de DijonDijon, FranceNo longer taking part
  • Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranceNo longer taking part
  • Departmental Hospital VendeeLa Roche Sur Yon Cedex 9, FranceNo longer taking part
  • Centre Hospitalier Groupe Hospitalier De La Rochelle Re AunisLa Rochelle, FranceNo longer taking part
  • Centre Hospitalier Le MansLe Mans Cedex 9, FranceNo longer taking part
  • Centre Hospitalier Regional Universitaire de LilleLille, FranceNo longer taking part
  • Hospices Civils De LyonLyon Cedex 02, FranceNo longer taking part
  • Assistance Publique Hôpitaux de MarseilleMarseille, FranceNo longer taking part
  • Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceNo longer taking part
  • Centre Hospitalier Universitaire De NantesNantes Cedex 1, FranceNo longer taking part
  • Centre Hospitalier de NiortNiort, FranceNo longer taking part
  • Assistance Publique Hopitaux de ParisParis, FranceNo longer taking part
  • Hopital Necker Enfants MaladesParis, FranceNo longer taking part
  • Hopital Saint LouisParis, FranceNo longer taking part
  • Centre Hospitalier Universitaire de PoitiersPoitiers, FranceNo longer taking part
  • Centre Hospitalier Universitaire De RennesRennes Cedex 9, FranceNo longer taking part
  • CHU De RouenRouen Cedex, FranceNo longer taking part
  • Centre Hospitalier Saint NazaireSaint Nazaire Cedex, FranceNo longer taking part
  • Centre Hospitalier Universitaire De La ReunionSaint-Denis, FranceNo longer taking part
  • HIA Sainte AnneToulon Cedex 9, FranceNo longer taking part
  • Centre Hospitalier Universitaire de ToulouseToulouse, FranceNo longer taking part
  • Centre Hospitalier Régional Universitaire de ToursTours, FranceNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Centre Hospitalier Universitaire De Nantes
Trial code
EU 2022-501179-23-00
Record updated
11 July 2025
Original description
demonstrate the non-inferiority of a step down dosage strategy (injection spacing) 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.Read full original descriptionShow less

demonstrate the non-inferiority of a step down dosage strategy (injection spacing) 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.

Inclusion: 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.

Exclusion: Amount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months and less than 60 mg/month; 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.

EU CTIS 2022-501179-23-00