Stopping Dupilumab in Adults With Controlled Severe Asthma
Tests stopping dupilumab versus continuing it in adults with well-controlled severe asthma.
Plain-language title generated from the registry record
Registry title: Withdrawal of Dupilumab in Severe Asthma
Key facts
- Where
- Amiens, Angers, Bayonne, Besançon, Bobigny, Brest, Caen Cedex 9, Cannes Cedex, Créteil, Dijon, Epagny Metz-tessy, Grenoble Cedex 9, Le Chesnay Rocquencourt, Le Kremlin-Bicetre, Le Mans Cedex 9, Lille Cedex, Lyon Cedex 04, Montivilliers, Nantes Cedex 01, Olivet, Paris Cedex 18, Pessac, Pierre-Bénite, Pontoise, Reims, Roubaix, Saint Pierre Cedex, Strasbourg, Suresnes, Tarbes Cedex 9, Toulouse, and Tours, FranceSee the 32 sites
- Phase
- Phase 4
Where in France
- Centre Hospitalier Universitaire Amiens - PicardieAmiens, FranceTaking people
- Centre Hospitalier Universitaire D'AngersAngers, FranceTaking people
- Centre Hospitalier de la Cote BasqueBayonne, FranceTaking people
- CHRU Jean MinjozBesançon, FranceTaking people
- Assistance Publique Hopitaux De ParisBobigny, FranceTaking people
- CHU Brest Hôpital de la Cavale BlancheBrest, FranceTaking people
- Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9, FranceTaking people
- Centre Hospitalier De Cannes Simone VeilCannes Cedex, FranceTaking people
- Centre Hospitalier Intercommunal CréteilCréteil, FranceTaking people
- CHU Dijon Bourgogne Hôpital François MitterandDijon, FranceTaking people
- Centre Hospitalier Annecy GenevoisEpagny Metz-tessy, FranceTaking people
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranceTaking people
- Centre Hospitalier De VersaillesLe Chesnay Rocquencourt, FranceTaking people
- Assistance Publique Hopitaux De ParisLe Kremlin-Bicetre, FranceTaking people
- Centre Hospitalier Le MansLe Mans Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire De LilleLille Cedex, FranceTaking people
- Hospital La Croix Rousse HclLyon Cedex 04, FranceTaking people
- Groupe Hospitalier Du HavreMontivilliers, FranceTaking people
- Centre Hospitalier Universitaire de Nantes - Hôpital Nord LaennecNantes Cedex 01, FranceTaking people
- Clinique De L'ArchetteOlivet, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 18, FranceTaking people
- CHU Bordeaux Haut-LevequePessac, FranceTaking people
- Centre Hospitalier Lyon-SudPierre-Bénite, FranceTaking people
- Hôpital NOVOPontoise, FranceTaking people
- CHU Reims Hôpital Maison BlancheReims, FranceTaking people
- Victor Provo HospitalRoubaix, FranceTaking people
- CHU de La Réunion sites SudSaint Pierre Cedex, FranceTaking people
- Centre d'Investigation Clinique - UF 1042 - CHRU Strasbourg - Nouvel Hôpital CivilStrasbourg, FranceTaking people
- Hospital FochSuresnes, FranceTaking people
- Centre Hospitalier Tarbes-LourdesTarbes Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranceTaking people
- Centre Hospitalier Régional Universitaire de ToursTours, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Toulouse
- Trial code
- NCT06818019EU 2024-516789-13-00
- Record updated
- 8 October 2026
- Original description
Asthma management has been revolutionised by the development of biological therapies. Dupilumab is an anti-interleukin4 receptor marketed in 2020 for severe asthmatic patients with 2 exacerbations or more within the last 12 months. Although data showed that safety and efficacy of dupilumab are sustained when treatment is extended up to 3 years, no study has emerged regarding dupilumab discontinuation. This study aims to demonstrate the non-inferiority regarding strategy failure at 24 months of stopping dupilumab (intervention group) compared with its continuation (control group) in controlled asthma patients receiving this drug for at least 3 years.Read full original descriptionShow less
WIthdrawal of DUpilumab in Severe Asthma: a Randomized Non-inferiority-controlled Trial
Asthma management has been revolutionised by the development of biological therapies. Dupilumab is an anti-interleukin4 receptor marketed in 2020 for severe asthmatic patients with 2 exacerbations or more within the last 12 months. Although data showed that safety and efficacy of dupilumab are sustained when treatment is extended up to 3 years, no study has emerged regarding dupilumab discontinuation. This study aims to demonstrate the non-inferiority regarding strategy failure at 24 months of stopping dupilumab (intervention group) compared with its continuation (control group) in controlled asthma patients receiving this drug for at least 3 years.
Inclusion: Adult patients ≥ 18 years old; Treated with dupilumab for at least 36 months for severe asthma; Well controlled asthma defined by an Asthma Control Questionnaire score ≥ 18 and 0 or 1 exacerbation within the year prior to the inclusion visit.
Exclusion: Patients treated by an oral corticosteroid dose ≥ 10 mg/day (in prednisone equivalent); Patients who have to discontinue dupilumab for a reason other than controlled asthma, such as an adverse drug reaction, a planned or current pregnancy, or a planned switch to another biologic indicated in severe asthma; Patients who refuse to discontinue dupilumab, for any reason; Patients with Forced expiratory volume in one second ≤ 30% of predicted values; Patients who have to continue dupilumab for the treatment of comorbidities apart from nasal polyposis; Active smoking; Pregnancy or breastfeeding.