Gene test may predict who benefits from asthma drug
NCT ID NCT03694158
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether people aged 12 and older with a certain gene variant (IL-4RαR576) respond better to the asthma drug dupilumab. 150 participants will receive either dupilumab or a placebo for 48 weeks. The main goal is to see if the drug reduces asthma attacks more in those with the gene variant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dupilumab (Dupixent®)
- What this could lead to
- If successful, this could show that people with the IL-4RαR576 gene variant get better asthma control from dupilumab, leading to more personalized treatment.
- What could go wrong
- This is a Phase 4 trial, but results may not apply to everyone with asthma. The benefit may be small or not significant, and dupilumab can cause side effects like injection reactions or infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2021
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Ages 12 years and older 2. Ability to provide informed consent 3. Ability to perform pulmonary function tests 4. Female participants of childbearing potential must have a negative urine pregnancy test upon study entry 5. Female participants with reproductive potential must agree to use FDA-approved methods of birth control for the duration of the study2 6. Participant-reported physician or licensed medical practitioner diagnosis of asthma 7. Treatment with medium to high dose ICS (400 mcg to maximum of 2000 mcg per day of fluticasone propionate or equivalent) for at least 3 months with a stable dose ≥1 month prior to screening OR used a biologic medication for asthma within the past 8 weeks 8. History of asthma exacerbation in the past year An exacerbation is an asthma attack for which a clinician prescribed a course of systemic (oral, IV, IM) steroids whether or not the patient took the steroids OR An increase of \>50% of baseline inhaled corticosteroid dose for ≥3 days OR An unscheduled visit for acute asthma attack (licensed medical practitioner/nurse office, urgent care intervention, emergency department, or hospitalization) Exclusion Criteria: 1. Chronic lung disease other than asthma, which may impair lung function 2. Current smoker or cessation of smoking ≤6 months prior to Visit 0 screening 3. Current use of any electronic (e) "vaping" device (e.g., e-cigarette, e-cig, mod, vape pen, JUUL, e-cigar, e-hookah, e-pipe, vape pods) or cessation ≤ 6 months prior to screening 4. Pregnant or breast feeding 5. Any other condition or abnormality that, in the opinion of the Principal Investigator, would compromise the safety of the patient or quality of data 6. Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures 7. Planning to relocate away from the clinical center area before study completion 8. Currently participating in an investigational drug trial or participated in one within 30 days before screening 9. Currently being treated with immunosuppressive/immunomodulatory or other investigational agents or biologics for conditions other than asthma, or used a biologic for a non-asthma indication within the past 6 months 10. History of respiratory illness requiring antibiotics or systemic corticosteroids, including asthma exacerbations, within the past 4 weeks (evaluated at time of screening visit) 11. History of alcohol or illicit substance abuse within 6 months of screening 12. Neutropenia (\<1,000/mm3) or thrombocytopenia (\<100,000/mm3) or hemoglobin \< 100 g/L (10 g/dL) or blood eosinophils \> 1500/mm3 at screening 13. Administration of a live vaccine within 4 weeks of screening 14. Currently receiving allergen immunotherapy (food or aeroallergen) other than an established maintenance regimen implemented continuously for a minimum of 2 months. Individuals receiving aeroallergen immunotherapy must be willing to stay on it for the duration of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Boston Children's Hospital
Boston, Massachusetts, 02115, United States
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Henry Ford Health System
Detroit, Michigan, 48202, United States
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MetroHealth System
Cleveland, Ohio, 44109, United States
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Montefiore Einstein Clinical Research Center
The Bronx, New York, 10467, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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