Overview

A Study to Evaluate the Efficacy and Safety of Dupilumab in Participants With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED)

Status:
Recruiting

Trial end date:
2023-10-23

Target enrollment:

Participant gender:

Summary

The primary objective of the study is to evaluate the efficacy of dupilumab on the annualized rate of exacerbations in participants with Allergic Bronchopulmonary Aspergillosis (ABPA). The secondary objectives of the study are: - To evaluate the effects of dupilumab on lung function 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

Phase:

Phase 3

Details

Lead Sponsor:

Regeneron Pharmaceuticals

Collaborator:

Sanofi