Trial · NCT04442269

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

NCT04442269, Phase 2, Completed, Regeneron Pharmaceuticals; results first posted 2024-08-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED). Trials, record NCT04442269. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04442269

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED)
NCT number: NCT04442269
Status: Completed
Phases: Phase 2
Enrollment: 62 participants, actual
Lead sponsor: Regeneron Pharmaceuticals
Conditions: Allergic Bronchopulmonary Aspergillosis
Interventions: dupilumab, Placebo
First posted: 2020-06-22
Last updated: 2025-04-04
Other registries' IDs: eudract:2019-002619-24
Results first posted: 2024-08-21

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo	At Week 24
Secondary	Annualized Rate of ABPA-related Exacerbations	Over the 24 to 52 Week Treatment Period	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)
Secondary	Annualized Rate of Severe Respiratory Exacerbations	Over the 24 to 52 Week Treatment Period	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)
Secondary	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	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)
Secondary	Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score	Over the 24 to 52 Week Treatment Period	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.
Secondary	Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score	Over the 24 to 52 Week Treatment Period	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).
Secondary	Percentage of Participants Achieving a Reduction in the SGRQ Total Score of 4 Points or Greater From Baseline	Up to 52 Weeks	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).
Secondary	Percent Change From Baseline in Total IgE in Serum	Over the 24 to 52 Week Treatment Period
Secondary	Percent Change From Baseline in A Fumigatus-specific IgE in Serum	Over the 24 to 52 Week Treatment Period
Secondary	Absolute Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)	Over the 24 to 52 Week Treatment Period

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo	At Week 24	Randomized participants with available data for analysis in the statistical model	Liters	LEAST_SQUARES_MEAN
SECONDARY	Annualized Rate of ABPA-related Exacerbations	Over the 24 to 52 Week Treatment Period	The full analysis set (FAS) includes all randomized participants. It is based on the treatment allocated as randomized	Events per person-year	NUMBER
SECONDARY	Annualized Rate of Severe Respiratory Exacerbations	Over the 24 to 52 Week Treatment Period	The full analysis set (FAS) includes all randomized participants. It is based on the treatment allocated as randomized	Events per person year	NUMBER
SECONDARY	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	The full analysis set (FAS) includes all randomized participants. It is based on the treatment allocated as randomized	Events per person year	NUMBER
SECONDARY	Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score	Over the 24 to 52 Week Treatment Period	Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest	ACQ-5 Score	MEAN
SECONDARY	Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score	Over the 24 to 52 Week Treatment Period	Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest	SGRQ Total Score	MEAN
SECONDARY	Percentage of Participants Achieving a Reduction in the SGRQ Total Score of 4 Points or Greater From Baseline	Up to 52 Weeks	Participants must have both the baseline and at least one post-baseline measurement at the given post-baseline time point to be included in the calculation of the proportion at the given post-baseline time point.	Percent	NUMBER
SECONDARY	Percent Change From Baseline in Total IgE in Serum	Over the 24 to 52 Week Treatment Period	Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest	Percent	MEAN
SECONDARY	Percent Change From Baseline in A Fumigatus-specific IgE in Serum	Over the 24 to 52 Week Treatment Period	Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest	Percent	MEAN
SECONDARY	Absolute Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)	Over the 24 to 52 Week Treatment Period	Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest	ppb	MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group79

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo	Placebo		0.002	Standard Error 0.0558	Liters
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo	Dupilumab 300 mg Q2W		0.203	Standard Error 0.0482	Liters
Annualized Rate of ABPA-related Exacerbations	Placebo	Adjusted Rate	NA	NA to NA	Events per person-year
Annualized Rate of ABPA-related Exacerbations	Dupilumab 300 mg Q2W	Adjusted Rate	NA	NA to NA	Events per person-year
Annualized Rate of ABPA-related Exacerbations	Placebo	Unadjusted Rate	0	0 to 0	Events per person-year
Annualized Rate of ABPA-related Exacerbations	Dupilumab 300 mg Q2W	Unadjusted Rate	0	0 to 0	Events per person-year
Annualized Rate of Severe Respiratory Exacerbations	Placebo	Adjusted Rate	1.551		Events per person year
Annualized Rate of Severe Respiratory Exacerbations	Dupilumab 300 mg Q2W	Adjusted Rate	0.695		Events per person year
Annualized Rate of Severe Respiratory Exacerbations	Placebo	Unadjusted Rate	0.943		Events per person year
Annualized Rate of Severe Respiratory Exacerbations	Dupilumab 300 mg Q2W	Unadjusted Rate	0.545		Events per person year

1 to 10 of 79Source ClinicalTrials.gov

See all 79 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	27
Overall Study	STARTED	Dupilumab 300 mg Q2W	35
Overall Study	COMPLETED	Placebo	20
Overall Study	COMPLETED	Dupilumab 300 mg Q2W	29
Overall Study	NOT COMPLETED	Placebo	7
Overall Study	NOT COMPLETED	Dupilumab 300 mg Q2W	6

Source ClinicalTrials.gov

Adverse events100

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	COVID-19	Infections and infestations	Placebo	3	27	3
other	COVID-19	Infections and infestations	Dupilumab 300 mg Q2W	6	35	6
other	Upper respiratory tract infection	Infections and infestations	Placebo	1	27	1
other	Upper respiratory tract infection	Infections and infestations	Dupilumab 300 mg Q2W	4	35	6
other	Urinary tract infection	Infections and infestations	Placebo	0	27	0
other	Urinary tract infection	Infections and infestations	Dupilumab 300 mg Q2W	4	35	6
other	Acute sinusitis	Infections and infestations	Placebo	2	27	2
other	Acute sinusitis	Infections and infestations	Dupilumab 300 mg Q2W	2	35	2
other	Bronchopulmonary aspergillosis allergic	Infections and infestations	Placebo	0	27	0
other	Bronchopulmonary aspergillosis allergic	Infections and infestations	Dupilumab 300 mg Q2W	2	35	5

1 to 10 of 100Source ClinicalTrials.gov

See all 100 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	1	27
Total, all-cause mortality	Dupilumab 300 mg Q2W	1	35
Total, other adverse events	Placebo	19	27
Total, other adverse events	Dupilumab 300 mg Q2W	29	35
Total, serious adverse events	Placebo	5	27
Total, serious adverse events	Dupilumab 300 mg Q2W	3	35

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33027187	DERIVED	PubMed
42845221	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Dupilumab 300 mg Q2W vs Placebo: deaths from any cause	Trial comparisons
Dupilumab 300 mg Q2W vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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