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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04442269
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief 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 radiological changes in the lungs 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

Condition or disease Intervention/treatment Phase
Allergic Bronchopulmonary Aspergillosis Drug: dupilumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : September 7, 2023
Estimated Study Completion Date : October 23, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: dupilumab
Loading subcutaneous (SC) dose on day 1, followed by SC dose, every two weeks (Q2W)
Drug: dupilumab
Single-use prefilled glass syringe administered by subcutaneous injection.
Other Names:
  • • DUPIXENT
  • • REGN668
  • • SAR231893

Experimental: Placebo
Matching dupilumab without active substance
Drug: Placebo
Matching placebo




Primary Outcome Measures :
  1. Annualized rate of severe respiratory exacerbations [ Time Frame: Up to Week 52 ]

Secondary Outcome Measures :
  1. Change in pre-bronchodilator Forced expiratory volume in 1 second (FEV1) compared to placebo [ Time Frame: At week 24 ]
  2. Change from baseline in pre-bronchodilator FEV1 compared to placebo [ Time Frame: At week 52 ]
  3. Annualized rate of ABPA-related exacerbations compared to placebo [ Time Frame: Up to 52 Weeks ]
  4. Annualized rate of severe respiratory exacerbations requiring either hospitalization or observation for >24 hours in an ED/urgent care facility compared to compared to placebo [ Time Frame: Up to 52 Weeks ]
  5. Change from baseline in Asthma Control Questionnaire (ACQ)-5 compared to placebo [ Time Frame: Up to 52 Weeks ]
    Questionnaire completed by patient to measure both the adequacy of asthma control and change in asthma control. The ACQ-5 score is the mean of the first 5 questions, between 0 (totally controlled) and 6 (severely uncontrolled). A higher score indicates lower asthma control.

  6. Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score compared to placebo [ Time Frame: Up to 52 Weeks ]
    Questionnaire will be completed by the patient to measure and quantify health status in adult patients with chronic airflow limitation. Global score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial) as well as a total score. Lower score indicates better Quality of Life (QoL).

  7. Percentage of participants achieving a reduction in the SGRQ score of 4 points or greater from baseline compared to placebo [ Time Frame: Up to 52 Weeks ]
  8. Change in mucus plugging score on chest computed tomography (CT) compared to placebo [ Time Frame: Up to 52 Weeks ]
  9. Percent change from baseline in total IgE in serum compared to placebo [ Time Frame: Up to 52 Weeks ]
  10. Percent change from baseline in A fumigatus-specific IgE in serum compared to placebo [ Time Frame: Up to 52 Weeks ]
  11. Percent and absolute change from baseline in fractional exhaled nitric oxide (FeNO) compared to placebo [ Time Frame: Up to 52 Weeks ]
  12. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 52 Weeks ]
  13. Incidence of treatment-emergent anti-drug antibody (ADA) responses and titer [ Time Frame: Up to 64 Weeks ]
  14. Concentrations of functional dupilumab in serum by treatment regimen [ Time Frame: Up to 64 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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 up to 10 mg/day or 30 mg every alternate day of OCS (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 have received systemic corticosteroids during 5 of the 6 months prior to the screening visit and between the screening and baseline visits.

Key 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 OCS, exacerbation requiring at least doubling of the daily 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 or with a history of a positive lower respiratory culture for P aeruginosa or other multi-drug-resistant, gram-negative bacilli; cystic fibrosis; sarcoidosis; interstitial lung disease not due to ABPA; chronic obstructive pulmonary disease [COPD] not due to ABPA; hypereosinophilic syndrome; etc) or 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)

NOTE: Other protocol defined inclusion / exclusion criteria applies.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04442269


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04442269    
Other Study ID Numbers: R668-ABPA-1923
2019-002619-24 ( EudraCT Number )
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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).
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aspergillosis
Pulmonary Aspergillosis
Aspergillosis, Allergic Bronchopulmonary
Mycoses
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Respiratory Tract Infections
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases