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

NCT04442269 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: R668-ABPA-19232019-002619-24
• Study Type: interventional
• Target: 62
• Locations: 10 countries
• Sites: 50

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo

  At Week 24

Secondary Outcomes (13)

• Annualized Rate of ABPA-related Exacerbations

  Over the 24 to 52 Week Treatment Period

• Annualized Rate of Severe Respiratory Exacerbations

  Over the 24 to 52 Week Treatment Period

• Annualized Rate of Severe Respiratory Exacerbations Requiring Either Hospitalization or Observation for >24 Hours in an ED/Urgent Care Facility

  Over the 24 to 52 Week Treatment Period

• Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score

  Over the 24 to 52 Week Treatment Period

• Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score

  Over the 24 to 52 Week Treatment Period

Study Arms (2)

dupilumab

EXPERIMENTAL

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

Drug: dupilumab

Placebo

EXPERIMENTAL

Matching dupilumab without active substance

Drug: Placebo

Interventions

dupilumab DRUG

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

Also known as: • DUPIXENT, • REGN668, • SAR231893

dupilumab

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (50)

Regeneron Study Site

Birmingham, Alabama, 35209, United States

Location

Regeneron Study Site

Scottsdale, Arizona, 85251, United States

Location

Regeneron Study Site

Bakersfield, California, 93301, United States

Location

Regeneron Study Site

La Jolla, California, 92093, United States

Location

Regeneron Study Site

Los Angeles, California, 90025, United States

Location

Regeneron Study Site

Riverside, California, 92506, United States

Location

Regeneron Study Site

Boise, Idaho, 83706, United States

Location

Regeneron Study Site

Iowa City, Iowa, 52242, United States

Location

Regeneron Study Site

New York, New York, 10032, United States

Location

Regeneron Study Site

The Bronx, New York, 10461, United States

Location

Regeneron Study Site

Columbus, Ohio, 43235, United States

Location

Regeneron Study Site

DuBois, Pennsylvania, 15801, United States

Location

Regeneron Study Site

Philadelphia, Pennsylvania, 19140, United States

Location

Regeneron Study Site

Haskovo, 6305, Bulgaria

Location

Regeneron Study Site

Razgrad, 7200, Bulgaria

Location

Regeneron Study Site

Smolyan, 4700, Bulgaria

Location

Regeneron Study Site

Sofia, 1142, Bulgaria

Location

Regeneron Study Site

Brest, 29609, France

Location

Regeneron Study Site

Lyon, 69004, France

Location

Regeneron Study Site

Marseille, 13015, France

Location

Regeneron Study Site

Montpellier, 34295, France

Location

Regeneron Study Site

Paris, 75018, France

Location

Regeneron Study Site

Rennes, 35033, France

Location

Regeneron Study Site

Tours, 37044, France

Location

Regeneron Study Site

Leipzig, Saxony, 4357, Germany

Location

Regeneron Study Site

Berlin, 10717, Germany

Location

Regeneron Study Site

Frankfurt am Main, 60389, Germany

Location

Regeneron Study Site

Budapest, 1083, Hungary

Location

Regeneron Study Site

Fukuyama, 7200001, Japan

Location

Regeneron Study Site

Kanagawa, 259-1193, Japan

Location

Regeneron Study Site

Nagoya, 454-8509, Japan

Location

Regeneron Study Site

Naka-gun, 3191113, Japan

Location

Regeneron Study Site

Sakai, 591-8555, Japan

Location

Regeneron Study Site

Yanagawa, 8320059, Japan

Location

Regeneron Study Site

Yokohama, 231-8682, Japan

Location

Regeneron Study Site

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Regeneron Study Site

Arnhem, 6815, Netherlands

Location

Regeneron Study Site

Breda, 4818 CK, Netherlands

Location

Regeneron Study Site

Eindhoven, 5623, Netherlands

Location

Regeneron Study Site

Zutphen, 7207, Netherlands

Location

Regeneron Study Site

Bialystok, 15-044, Poland

Location

Regeneron Study Site

Gdansk, 80402, Poland

Location

Regeneron Study Site

Oradea, Bihor County, 410169, Romania

Location

Regeneron Study Site

Brasov, 500051, Romania

Location

Regeneron Study Site

Leicester, England, LE39QP, United Kingdom

Location

Regeneron Study Site

Liverpool, England, L7 8XP, United Kingdom

Location

Regeneron Study Site

London, England, E1 2EF, United Kingdom

Location

Regeneron Study Site

London, England, SW3 6NP, United Kingdom

Location

Regeneron Study Site

Wythenshawe, England, M23 9LT, United Kingdom

Location

Regeneron Study Site

Bradford, West Yorkshire, BD96RJ, United Kingdom

Location

Related Publications (1)

• Kao CC, Hanania NA, Parulekar AD. The impact of fungal allergic sensitization on asthma. Curr Opin Pulm Med. 2021 Jan;27(1):3-8. doi: 10.1097/MCP.0000000000000740.

  PMID: 33027187 DERIVED

Related Links

• A Plain Language Summary is available on TrialSummaries.com

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 22, 2020
• Study Start: September 15, 2020
• Primary Completion: July 27, 2023
• Study Completion: February 9, 2024
• Last Updated: April 4, 2025
• Results First Posted: August 21, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

Locations

US (13); GB (6); HU (1); NL (5); RO (2); BU (4); JP (7); PL (2); FR (7); DE (3)