A Study to Evaluate the Efficacy and Safety of Dupilumab in Participants With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED)
- Conditions
- Allergic Bronchopulmonary Aspergillosis
- Registration Number
- JPRN-jRCT2080225350
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 10
Key Inclusion Criteria:
-Diagnosis of both ABPA and asthma.
-On a maintenance therapy for their asthma with controller medication which must include inhaled corticosteroids (ICS) and may include 1 or more additional controller medications including a long-acting beta agonist (LABA), leukotriene receptor antagonist (LTRA), and/or long-acting muscarinic receptor antagonist (LAMA), etc for at least 12 weeks, with a stable dose and regimen with no change in the dose or frequency of administration for at least 4 weeks prior to the screening visit and between the screening and baseline/randomization visits
-For participants on OCS (oral corticosteroid): must be on a chronic stable dose (no change in the dose) of up to 10 mg/day or 30 mg every alternate day of OCS (prednisone/prednisolone or the equivalent) for at least 4 weeks prior to the screening visit and between the screening and the baseline/randomization visit.
-Must have experienced >=1 severe respiratory exacerbation requiring treatment with systemic corticosteroids or hospitalization or treatment in ED/urgent care within 12 months prior to the screening visit or must have received systemic corticosteroids during 5 of the 6 months prior to the screening visit and between the screening and baseline visits.
Key Exclusion Criteria:
-Weight less than 30.0 kilograms
-Current smoker or e-cigarette user, cessation of smoking or e-cigarette use within 6 months prior to randomization, or >10 pack-years smoking history
-Post-bronchodilator FEV1 <30% predicted normal at screening
-Respiratory exacerbation requiring systemic corticosteroids within 4 weeks prior to screening and between screening and baseline visit (for patients on daily OCS, exacerbation requiring at least doubling of the daily maintenance dose of corticosteroids)
-Upper or lower respiratory tract infection within the 4 weeks prior to screening (visit 1) or between the screening and randomization visits
-Significant chronic pulmonary disease other than asthma complicated with ABPA (eg, physician-diagnosed bronchiectasis due to a condition other than ABPA or with a history of a positive lower respiratory culture for P aeruginosa or other multi-drug-resistant, gram-negative bacilli; cystic fibrosis; sarcoidosis; interstitial lung disease not due to ABPA; chronic obstructive pulmonary disease [COPD] not due to ABPA; hypereosinophilic syndrome; etc) or a diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts
-Diagnosis or suspected diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) (also called Churg-Strauss Syndrome)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Annualized rate of severe respiratory exacerbations
- Secondary Outcome Measures
Name Time Method