Investigating Dupilumab's Effect in Asthma by Genotype

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Antibodies, Monoclonal

Criteria

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.