Withdrawal of Dupilumab in Severe Asthma
ConditionSevere Asthma
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Stopping dupilumab
Treatment groups
205 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov