Withdrawal of Dupilumab in Severe Asthma

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at what happens when patients with severe asthma stop taking a medication called dupilumab after using it for at least three years. Dupilumab helps many people manage their asthma, but until now, there hasn’t been much research on the effects of stopping this treatment. The study will compare two groups: one group will continue taking dupilumab, while the other group will stop. The goal is to see if stopping the medication leads to the same level of asthma control and fewer flare-ups as continuing the treatment over a two-year period.

To be eligible for this trial, participants must be adults aged 18 or older who have been using dupilumab for at least 36 months and have their asthma well-controlled, meaning they have had few asthma attacks in the past year. However, certain people are not eligible, such as those who smoke, are pregnant or breastfeeding, or have other specific health issues. Patients who join the study can expect close monitoring and support as researchers gather important information about the effects of stopping dupilumab on their asthma control.

Gender

ALL

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