Investigating Dupilumab's Effect in Asthma by Genotype

Running, not enrolling · Phase 4 · Has a placebo group

Conditions studied: Asthma

In brief

The Goal of this study is to investigate if individuals ages 12 years and older, carrying the IL-4RαR576 gene variant, will have a greater response to therapy acting directly on the anti-IL-4R. This will be conducted by examining the effect of a 48 week therapy with dupilumab on the rate of asthma exacerbations.

Key facts

Study ID

NCT03694158

Run by

Boston Children's Hospital

People needed

150

Starts

2021-09-08

Expected to finish

2027-03-01

Last updated by the study team

2026-02-23

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 12 years and older
• Ability to provide informed consent
• Ability to perform pulmonary function tests
• Female participants of childbearing potential must have a negative urine pregnancy test upon study entry
• Female participants with reproductive potential must agree to use FDA-approved methods of birth control for the duration of the study2
• Participant-reported physician or licensed medical practitioner diagnosis of asthma
• 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
• 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)

You may not qualify if…

• Chronic lung disease other than asthma, which may impair lung function
• Current smoker or cessation of smoking ≤6 months prior to Visit 0 screening
• 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
• Pregnant or breast feeding
• Any other condition or abnormality that, in the opinion of the Principal Investigator, would compromise the safety of the patient or quality of data
• Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures
• Planning to relocate away from the clinical center area before study completion
• Currently participating in an investigational drug trial or participated in one within 30 days before screening
• 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
• History of respiratory illness requiring antibiotics or systemic corticosteroids, including asthma exacerbations, within the past 4 weeks (evaluated at time of screening visit)
• History of alcohol or illicit substance abuse within 6 months of screening
• Neutropenia (<1,000/mm3) or thrombocytopenia (<100,000/mm3) or hemoglobin < 100 g/L (10 g/dL) or blood eosinophils > 1500/mm3 at screening
• Administration of a live vaccine within 4 weeks of screening
• 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.

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Montefiore Einstein Clinical Research Center — The Bronx, New York, United States
• MetroHealth System — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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