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

Last Updated: 2025-04-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2024-02-09

Brief Summary

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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

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Detailed Description

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Conditions

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Allergic Bronchopulmonary Aspergillosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dupilumab

Loading subcutaneous (SC) dose on day 1, followed by SC dose, every two weeks (Q2W)

Group Type EXPERIMENTAL

dupilumab

Intervention Type DRUG

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

Placebo

Matching dupilumab without active substance

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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dupilumab

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

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Other Intervention Names

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• DUPIXENT • REGN668 • SAR231893

Eligibility Criteria

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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

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)

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers