Efficacy and Safety of Dupilumab in Participants with ABPA
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUPSTUDY TO EVALUATE THE EFFICACY AND SAFETY OF DUPILUMAB IN PATIENTS WITH ALLERGIC BRONCHOPULMONARY ASPERGILLOSIS
Regeneron Pharmaceuticals, Inc
Duration of Study in the UK
3 years, 7 months, 10 days
This is a randomised, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Dupilumab in Patients with Allergic Bronchopulmonary Aspergillosis (ABPA). ABPA is a progressive, immunologic lung disease caused by hypersensitive reaction to the fungus Aspergillus fumigatus (A. fumigatus) that occurs in patients with asthma or cystic fibrosis. ABPA is associated with thick mucus secretions, airway obstruction, shortness of breath, coughing, wheezing, lungs remain persistently widened (which does not otherwise occur in asthma), and lung function impairment. Approximately 20-30% of asthma patients are sensitised to this fungus.
Dupilumab is an approved add-on maintenance treatment in patients with moderate to severe asthma aged 12 years and older in Europe and America. Dupilumab is believed to have the potential to inhibit the inflammatory response caused by ABPA. Dupilumab will be compared against a placebo to see if the study drug works better or is as safe as not taking anything at all.
Approximately 170 patients with ABPA (adults and adolescents (≥12 years of age)) are expected to participate in this study at 80 sites globally over 64 weeks and will visit the trial site 15 times. The 3 study periods are screening (4 weeks) to evaluate if the patient can participate in the study, treatment (52 weeks +/- 3 days) and post-treatment follow-up (12 weeks +/- 7 days).
The current treatment for ABPA is administration of oral, long-term, high-dose steroids, which leads to corticosteroid-dependency to control the disease. Antifungals are an additional treatment but can cause nausea, vomiting, diarrhoea, fever, rash, headache, and liver toxicity. There is an unmet need for more effective and safe treatments that target the effects of ABPA to prevent irreversible airway damage, improve clinical symptoms, and eliminate the need for corticosteroids with their accompanying safety concerns.
South Central - Oxford B Research Ethics Committee
Date of REC Opinion
27 Aug 2020
Further Information Favourable Opinion