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Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED)

NCT04442269 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-04-04

Study results available
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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

Conditions

  • Allergic Bronchopulmonary Aspergillosis

Interventions

DRUG

dupilumab

Single-use prefilled glass syringe administered by subcutaneous (SC) injection.

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2023-07-27
Completion
2024-02-09
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • France
  • Germany
  • Hungary
  • Japan
  • Netherlands
  • Poland
  • Romania
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04442269 on ClinicalTrials.gov