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

Conditions

• Allergic Bronchopulmonary Aspergillosis

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• dupilumab — DRUG
  Single-use prefilled glass syringe administered by subcutaneous (SC) injection.
• Placebo — DRUG
  Matching placebo

Study Details

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

Key Dates

Start date

Sep 15, 2020

Status verified

Apr 2025

Primary completion

Jul 27, 2023

Completion

Feb 9, 2024

Study Design

Enrollment

62 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: dupilumab
  Loading subcutaneous (SC) dose on day 1, followed by SC dose, every two weeks (Q2W)
• Experimental: Placebo
  Matching dupilumab without active substance

Primary Outcome Measure

Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo [ Time Frame: At Week 24 ]

Locations (13)

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