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Withdrawal of Dupilumab in Severe Asthma
Sponsor: University Hospital, Toulouse
Summary
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.
Official title: WIthdrawal of DUpilumab in Severe Asthma: a Randomized Non-inferiority-controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
205
Start Date
2025-04-02
Completion Date
2029-12-31
Last Updated
2025-02-10
Healthy Volunteers
No
Conditions
Interventions
Stopping dupilumab
Stopping dupilumab with no dose-reducing or interval of time-increasing strategy
Locations (29)
CHU de Toulouse
Toulouse, CHU de Toulouse, France
CHU Amiens-Picardie
Amiens, France, France
CHR d'Angers
Angers, France, France
CH de Bayonne
Bayonne, France, France
CHU de Besançon
Besançon, France, France
CHU de Brest
Brest, France, France
CHU de Caen
Caen, France, France
CH de Cannes
Cannes, France, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, France
CHI de Créteil
Créteil, France, France
CHU de Dijon
Dijon, France, France
CH Annecy Genevois
Epagny-Metz-Annecy, France, France
CHU Grenoble-Alpes
La Tronche, France, France
Hôpital Kremlin Bicêtre
Le Kremlin-Bicêtre, France, France
CH Le Mans
Le Mans, France, France
Institut Coeur Poumon, CHU de Lille
Lille, France, France
Hôpital Croix Rousse
Lyon, France, France
Hôpital Avicenne
Paris, France, France
Hôpital Européen Georges Pompidou
Paris, France, France
Hôpital Bichât
Paris, France, France
CHU de Bordeaux
Pessac, France, France
Hôpital Lyon Sud
Pierre-Bénite, France, France
CHU de Guadeloupe
Pointe à Pitre, France, France
CHU de Reims
Reims, France, France
CH de Roubaix
Roubaix, France, France
CHU de Nantes
Saint-Herblain, France, France
Nouvel Hôpital Civil
Strasbourg, France, France
Hôpital Foch
Suresnes, France, France
Hôpital Tarbes Lourdes
Tarbes, France, France