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Monoclonal Antibodies

Dupilumab for Allergic Bronchopulmonary Aspergillosis

Phase 2
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of both ABPA and asthma
For participants on OCS: must be on a chronic stable dose for at least 4 weeks prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over the 24 to 52 week treatment period
Awards & highlights

Study Summary

This trial will study the effects of the medication dupilumab on people with Allergic Bronchopulmonary Aspergillosis, specifically looking at the rate of exacerbations, lung function, health-related quality of life, and other measures.

Who is the study for?
This trial is for people with both Allergic Bronchopulmonary Aspergillosis (ABPA) and asthma, who've been on stable asthma treatment for at least 4 weeks. They must have had a severe respiratory issue treated with steroids or hospitalization in the past year. Smokers or those with other major lung diseases can't participate.Check my eligibility
What is being tested?
The study aims to see if Dupilumab improves lung function in ABPA patients compared to a placebo. It also looks at how Dupilumab affects exacerbations, emergency visits, asthma control, quality of life, IgE levels, FeNO levels, safety and tolerability.See study design
What are the potential side effects?
Dupilumab may cause side effects like allergic reactions where the drug is injected, eye problems (like redness or itching), cold sores in your mouth or throat area and inflammation of blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with both allergic bronchopulmonary aspergillosis (ABPA) and asthma.
Select...
You have had a serious breathing problem that needed strong medicine or a hospital stay in the past year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over the 24 to 52 week treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and over the 24 to 52 week treatment period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) compared to placebo
Secondary outcome measures
Absolute change from baseline in FeNO
Annualized rate of ABPA-related exacerbations
Annualized rate of severe respiratory exacerbations
+10 more

Side effects data

From 2023 Phase 4 trial • 40 Patients • NCT04203797
5%
Sinus pain
5%
Asthma
5%
Immunisation reaction
5%
Rhinitis
5%
Injection site erythema
5%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dupilumab 300 mg Q2W
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: dupilumabExperimental Treatment1 Intervention
Loading subcutaneous (SC) dose on day 1, followed by SC dose, every two weeks (Q2W)
Group II: PlaceboExperimental Treatment1 Intervention
Matching dupilumab without active substance
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dupilumab
2022
Completed Phase 4
~330
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
621 Previous Clinical Trials
380,543 Total Patients Enrolled
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,918 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
263 Previous Clinical Trials
251,352 Total Patients Enrolled

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04442269 — Phase 2
Allergic Bronchopulmonary Aspergillosis Research Study Groups: dupilumab, Placebo
Allergic Bronchopulmonary Aspergillosis Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT04442269 — Phase 2
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04442269 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can more people join this research project?

"Yes, the information on clinicaltrials.gov suggests that this clinical trial is currently searching for patients. The clinical trial was first posted on 9/15/2020 and was last updated on 10/17/2022. The clinical trial is searching for 170 participants at 24 sites."

Answered by AI

Are there a number of research facilities testing this in North America?

"To make participating as convenient as possible, this clinical trial has 24 sites throughout Ottawa, H4a3j1, Atherton, and other cities."

Answered by AI

What is the precedence for dupilumab as a treatment?

"Dupilumab is the focus of 53 different clinical trials, 14 of which are in the final stage. The majority of research facilities are based in Louisville, however, there are 2662 total locations running trials for dupilumab."

Answered by AI

Has the FDA greenlit dupilumab for general use?

"dupilumab's safety is estimated to be a 3. This comes from the fact that dupilumab is in Phase 3 trials, which implies that there is both evidence of efficacy and multiple rounds of supporting data."

Answered by AI

How many people are volunteering to participate in this research?

"That is accurate. The information found on clinicaltrials.gov shows that this study is currently looking for 170 participants between 24 sites. The clinical trial was first posted on 9/15/2020 and was last edited on 10/17/2022."

Answered by AI

Has this treatment method been tested before?

"Dupilumab has been researched since 2015, when the first study was sponsored by Sanofi. 880 patients were involved in the first study. After Phase 3 approval, 53 clinical trials began in455 cities and 43 countries."

Answered by AI

How is dupilumab typically used to treat patients?

"Dermatitis, atopic is often treated effectively with dupilumab. Additionally, dupilumab has shown to be successful in managing other conditions such as failure with corticosteroid therapy, eosinophil, and asthma."

Answered by AI
~14 spots leftby Apr 2025