Investigating Dupilumab's Effect in Asthma by Genotype

Description

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.

Conditions

Asthma

Study Overview

Study Details

Study overview

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.

Effect of IL-4RαR576 Polymorphism on Response to Dupilumab in Asthma, a Genotype-stratified, Randomized, Placebo- Controlled Trial

Investigating Dupilumab's Effect in Asthma by Genotype

Condition
Asthma
Intervention / Treatment

-

Contacts and Locations

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Detroit

Henry Ford Health System, Detroit, Michigan, United States, 48202

Cedar Knolls

Atlantic Health System, Cedar Knolls, New Jersey, United States, 07927

Bronx

Montefiore Einstein Clinical Research Center, Bronx, New York, United States, 10467

Cleveland

MetroHealth System, Cleveland, Ohio, United States, 44109

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Children's Hospital,

Wanda Phipatanakul, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

2027-03