investigating treatment with dupilumab in patients with allergic bronchopulmonary aspergillosis (abpa) (liberty abpa aired)

Conditions: Allergic Bronchopulmonary Aspergillosis

Summary: the primary objective of the study is to evaluate the efficacy of dupilumab on lung function in participants with allergic bronchopulmonary aspergillosis (abpa). the secondary objectives of the study are: * to evaluate the effects of dupilumab on exacerbations in participants with abpa * to evaluate the effects of dupilumab on abpa-related exacerbations * to evaluate the effects of dupilumab on hospitalization/emergency department (ed)/urgent care visits in participants with abpa * to evaluate the effects of dupilumab on asthma control in participants with abpa * to evaluate the effects of dupilumab on health-related quality of life (hrqol) in participants with abpa * to evaluate the effects of dupilumab on serum total immunoglobulin e (ige) and aspergillus-specific ige concentrations * to evaluate the effects of dupilumab on fractional exhaled nitric oxide (feno) levels * to evaluate safety and tolerability of dupilumab in participants with abpa * to evaluate dupilumab concentrations in serum and the incidence of anti-dupilumab antibodies in participants with abpa


Eligibility criteria:
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 ocs of up to 10 mg/day (for participants taking daily corticosteroids) or up to 30 mg every alternate day (for participants taking alternate day corticosteroids) (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 be receiving chronic stable low-dose ocs per above criteria 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 or alternate day ocs, exacerbation requiring at least double the 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; cystic fibrosis; sarcoidosis; interstitial lung disease not due to abpa; chronic obstructive pulmonary disease \[copd\] not due to abpa; hypereosinophilic syndrome; etc), 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) note: other protocol defined inclusion / exclusion criteria applies.