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Withdrawal of Dupilumab in Severe Asthma

RecruitingPhase 4Ages 18 Years - anyAllUniversity Hospital, Toulouse
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Stopping dupilumab
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Where

29 sites
CHU de Toulouse
Toulouse, France
CHU Amiens-Picardie
Amiens, France
CHR d'Angers
Angers, France
CH de Bayonne
Bayonne, France
CHU de Besançon
Besançon, France
CHU de Brest
Brest, France
CHU de Caen
Caen, France
CH de Cannes
Cannes, France

…and 21 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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