A Study to Evaluate the Efficacy and Safety of Dupilumab in Patients with Allergic Bronchopulmonary Aspergillosis

Phase 1

• Conditions: Allergic bronchopulmonary aspergillosis (ABPA); MedDRA version: 20.1Level: LLTClassification code 10001707Term: Allergic bronchopulmonary aspergillosisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-002619-24-HU
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-10
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1. Diagnoses of both ABPA and asthma.
2. On a maintenance therapy for their asthma with controller medication which must include ICS and may include 1 or more additional controller medications including a LABA, LTRA, and/or 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
3. For patients on OCS: 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.
4. 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.

NOTE: Other protocol defined inclusion criteria apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 144
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1. Weight less than 30.0 kilograms
2. 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
3. Post-bronchodilator FEV1 <30% predicted normal at screening
4. 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)
5. Upper or lower respiratory tract infection within the 4 weeks prior to screening (visit 1) or between the screening and randomization visits
6. 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
7. Diagnosis or suspected diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA; also called Churg-Strauss Syndrome)

NOTE: Other protocol defined exclusion criteria apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified