Allergic Bronchopulmonary AspergillosisPhase 2NCT04442269

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

A Phase 2 study testing dupilumab in people with Allergic Bronchopulmonary Aspergillosis, run by Regeneron Pharmaceuticals at 50 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Allergic Bronchopulmonary Aspergillosis
What is being tested?: dupilumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 62 participants
Where: 50 sitesin 10 countries
Study dates: 15 Sep 2020to 9 Feb 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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)
NOTE: Other protocol defined inclusion / exclusion criteria applies.

Trial locations and contacts

50 sites in 10 countries.

Country

City, postcode or hospital

50 sites in 10 countries

United States13 sites

Regeneron Study Site
Bakersfield, California, 93301
Regeneron Study Site
Birmingham, Alabama, 35209
Regeneron Study Site
Boise, Idaho, 83706
Regeneron Study Site
Columbus, Ohio, 43235
Regeneron Study Site
DuBois, Pennsylvania, 15801
Regeneron Study Site
Iowa City, Iowa, 52242
Regeneron Study Site
La Jolla, California, 92093
Regeneron Study Site
Los Angeles, California, 90025
Regeneron Study Site
New York, New York, 10032
Regeneron Study Site
Philadelphia, Pennsylvania, 19140
Regeneron Study Site
Riverside, California, 92506
Regeneron Study Site
Scottsdale, Arizona, 85251
Regeneron Study Site
The Bronx, New York, 10461

Other trials in United States

France7 sites

Regeneron Study Site
Brest, 29609
Regeneron Study Site
Lyon, 69004
Regeneron Study Site
Marseille, 13015
Regeneron Study Site
Montpellier, 34295
Regeneron Study Site
Paris, 75018
Regeneron Study Site
Rennes, 35033
Regeneron Study Site
Tours, 37044

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Japan7 sites

Regeneron Study Site
Fukuyama, 7200001
Regeneron Study Site
Kanagawa, 259-1193
Regeneron Study Site
Nagoya, 454-8509
Regeneron Study Site
Naka-gun, 3191113
Regeneron Study Site
Sakai, 591-8555
Regeneron Study Site
Yanagawa, 8320059
Regeneron Study Site
Yokohama, 231-8682

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United Kingdom6 sites

Regeneron Study Site
Bradford, West Yorkshire, BD96RJ
Regeneron Study Site
Leicester, England, LE39QP
Regeneron Study Site
Liverpool, England, L7 8XP
Regeneron Study Site
London, England, E1 2EF
Regeneron Study Site
London, England, SW3 6NP
Regeneron Study Site
Wythenshawe, England, M23 9LT

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Netherlands5 sites

Regeneron Study Site
Amsterdam, North Holland, 1105AZ
Regeneron Study Site
Arnhem, 6815
Regeneron Study Site
Breda, 4818 CK
Regeneron Study Site
Eindhoven, 5623
Regeneron Study Site
Zutphen, 7207

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Bulgaria4 sites

Regeneron Study Site
Haskovo, 6305
Regeneron Study Site
Razgrad, 7200
Regeneron Study Site
Smolyan, 4700
Regeneron Study Site
Sofia, 1142

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Germany3 sites

Regeneron Study Site
Berlin, 10717
Regeneron Study Site
Frankfurt am Main, 60389
Regeneron Study Site
Leipzig, Saxony, 4357

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Poland2 sites

Regeneron Study Site
Bialystok, 15-044
Regeneron Study Site
Gdansk, 80402

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Romania2 sites

Regeneron Study Site
Brasov, 500051
Regeneron Study Site
Oradea, Bihor County, 410169

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Hungary1 site

Regeneron Study Site
Budapest, 1083

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About this study

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

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
Being tested: dupilumab, Placebo
Medical subject headings: Aspergillosis, Allergic Bronchopulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dupilumabDrug
Also called • DUPIXENT, • REGN668, • SAR231893
Single-use prefilled glass syringe administered by subcutaneous (SC) injection.
PlaceboDrug
Matching placebo

Study groups in NCT04442269
Study group	Role	What they receive
dupilumab	Experimental	Loading subcutaneous (SC) dose on day 1, followed by SC dose, every two weeks (Q2W) Receives: Drug: dupilumab
Placebo	Experimental	Matching dupilumab without active substance Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (13)

Annualized Rate of ABPA-related Exacerbations
Defined as severe respiratory exacerbations that are associated with a doubling of serum total Immunoglobulin E (IgE) from the prior pre-exacerbation value.
Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years)
Measured: Over the 24 to 52 Week Treatment Period
Annualized Rate of Severe Respiratory Exacerbations
Defined as new onset of symptoms or clinical worsening of respiratory symptoms requiring systemic corticosteroid treatment for ≥3 consecutive days; for participants who are on maintenance systemic corticosteroids, at least double the dose of maintenance systemic corticosteroids for ≥3 consecutive days (with or without antibiotic therapy if indicated)
Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years)
Measured: 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
Annualized rate of severe respiratory exacerbations requiring either hospitalization or observation for >24 hours in an emergency department/urgent care facility (events per person-year)
Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years)
Measured: Over the 24 to 52 Week Treatment Period
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score
ACQ is completed by patient to measure both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. 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. Participants with a score below 1.0 reflect adequately controlled asthma and participants with scores above 1.0 reflect inadequately controlled asthma. The optimal cut-point score of 1.50 should be used to be confident that a patient has inadequately controlled asthma.
Measured: Over the 24 to 52 Week Treatment Period
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score
SGRQ will be completed by the patient to measure and quantify health status in adult participants with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL).
Measured: Over the 24 to 52 Week Treatment Period
Percentage of Participants Achieving a Reduction in the SGRQ Total Score of 4 Points or Greater From Baseline
SGRQ will be completed by the patient to measure and quantify health status in adult participants with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL).
Measured: Up to 52 Weeks
Percent Change From Baseline in Total IgE in Serum
Measured: Over the 24 to 52 Week Treatment Period
Percent Change From Baseline in A Fumigatus-specific IgE in Serum
Measured: Over the 24 to 52 Week Treatment Period
Absolute Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Measured: Over the 24 to 52 Week Treatment Period
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Measured: Over the 24 to 52 Week Treatment Period
Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Baseline
Measured: Through the end of the 52 Week Treatment Period
Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Responses and Titer Over Time
Measured: Up to 64 Weeks
Concentrations of Functional Dupilumab in Serum by Treatment Regimen
Measured: Up to 64 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 20209 Feb 2024

First posted22 Jun 2020
Study start15 Sep 2020
Primary completion27 Jul 2023
Study completion9 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Allergic Bronchopulmonary AspergillosisStudies of the same condition, open and under way.
More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04442269
Sponsor's protocol ID: R668-ABPA-1923
Other IDs: 2019-002619-24, 2019
Status last verified: Apr 2025
First submitted: 4 Jun 2020
Last updated: 4 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Publications

Asano K, Okada N, Tanaka J, Tomomatsu K, Shiraishi Y, Oguma T. Advances in the Diagnosis and Management of Allergic Bronchopulmonary Aspergillosis/Mycosis. Allergy Asthma Immunol Res. 2026 Sep;18(5):626-639. doi: 10.4168/aair.2026.18.5.626.
PubMed 42845221
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.
PubMed 33027187

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
Allergic Bronchopulmonary Aspergillosis, ABPA
RecruitingObservational study
T2AIR: Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation in Asthma and COPD
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Not yet recruiting
Real-World Effectiveness of Tezepelumab in Allergic Bronchopulmonary Aspergillosis
Allergic Bronchopulmonary Aspergillosis, Severe Asthma
RecruitingObservational study
ML-Based ABPA Recurrence Prediction and Clinical Utility
ABPA, Allergic Bronchopulmonary Aspergillosis
RecruitingObservational study
Fungal Status and Prognosis in ABPA
ABPA, Allergic Bronchopulmonary Aspergillosis

All Allergic Bronchopulmonary Aspergillosis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04442269
Acronym / sponsor ID: R668-ABPA-1923
Conditions: Allergic Bronchopulmonary Aspergillosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Sanofi
Study start: 15 Sep 2020 (actual)
Primary completion: 27 Jul 2023 (actual)
Study completion: 9 Feb 2024 (actual)
First posted: 22 Jun 2020 (actual)
Results: Posted 21 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
dupilumab	Experimental	Drug: dupilumabLoading subcutaneous (SC) dose on day 1, followed by SC dose, every two weeks (Q2W)
Placebo	Experimental	Drug: PlaceboMatching dupilumab without active substance

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dupilumabAlso: • DUPIXENT, • REGN668, • SAR231893Single-use prefilled glass syringe administered by subcutaneous (SC) injection.	Drug	dupilumab
PlaceboMatching placebo	Drug	Placebo

Primary outcome

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

13 secondary outcomes

Annualized Rate of ABPA-related Exacerbations
Time frame: Over the 24 to 52 Week Treatment Period
Annualized Rate of Severe Respiratory Exacerbations
Time frame: 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
Time frame: Over the 24 to 52 Week Treatment Period
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score
Time frame: Over the 24 to 52 Week Treatment Period
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score
Time frame: Over the 24 to 52 Week Treatment Period
Percentage of Participants Achieving a Reduction in the SGRQ Total Score of 4 Points or Greater From Baseline
Time frame: Up to 52 Weeks
Percent Change From Baseline in Total IgE in Serum
Time frame: Over the 24 to 52 Week Treatment Period
Percent Change From Baseline in A Fumigatus-specific IgE in Serum
Time frame: Over the 24 to 52 Week Treatment Period
Absolute Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Over the 24 to 52 Week Treatment Period
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Over the 24 to 52 Week Treatment Period
Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Baseline
Time frame: Through the end of the 52 Week Treatment Period
Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Responses and Titer Over Time
Time frame: Up to 64 Weeks
Concentrations of Functional Dupilumab in Serum by Treatment Regimen
Time frame: Up to 64 Weeks

Results and safety

Results posted to the registry on 21 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	27	20
Dupilumab 300 mg Q2W	35	29

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

Time frame: At Week 24. Least squares mean (Standard Error). Unit: Liters

Measure	Placebo n = 26	Dupilumab 300 mg Q2W n = 34
Value	0.002 (0.0558)	0.203 (0.0482)

Placebo vs Dupilumab 300 mg Q2W: Mean Difference: 0.201 (95% CI 0.0768 to 0.3256), p = 0.0022, Mixed Models Analysis

Population analysed: Randomized participants with available data for analysis in the statistical model

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 27 (18.5%)	19 of 27 (70.4%)	1 of 27
Dupilumab 300 mg Q2W	3 of 35 (8.6%)	29 of 35 (82.9%)	1 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42845221Asano K, Okada N, Tanaka J, Tomomatsu K, Shiraishi Y, Oguma T. Advances in the Diagnosis and Management of Allergic Bronchopulmonary Aspergillosis/Mycosis. Allergy Asthma Immunol Res. 2026 Sep;18(5):626-639. doi: 10.4168/aair.2026.18.5.626.
Derived from this study: PubMed 33027187Kao 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.
A Plain Language Summary is available on TrialSummaries.comLink provided by the sponsor.
Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Related trials for Allergic Bronchopulmonary Aspergillosis

Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
Allergic Bronchopulmonary Aspergillosis, ABPA
RecruitingObservational study
T2AIR: Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation in Asthma and COPD
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trial Management study director

Regeneron Pharmaceuticals

50 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dupilumab in people with Allergic Bronchopulmonary Aspergillosis, run by Regeneron Pharmaceuticals at 50 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, France, Japan, United Kingdom, Netherlands and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04442269, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.