RECRUITING Phase 4 ClinicalTrials.gov

Withdrawal of Dupilumab in Severe Asthma

Sponsor: University Hospital, Toulouse • ClinicalTrials.gov ID: NCT06818019

Registry updated: 2026-10-08

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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.

Interventions

Stopping dupilumab (Drug)
Stopping dupilumab with no dose-reducing or interval of time-increasing strategy

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * Patients who refuse to discontinue dupilumab, for any reason * Patients with Forced expiratory volume in one second ≤ 30% of predicted values * 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 have to continue dupilumab for the treatment of comorbidities apart from nasal polyposis * Active smoking * Pregnancy or breastfeeding

Conditions

Severe Asthma

Locations

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 Reims — Reims, France, France
CH de Roubaix — Roubaix, France, France
CHU de La Réunion — Saint-Denis, 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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