RECRUITING

Investigating Dupilumab's Effect in Asthma by Genotype

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-09-08

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03694158

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.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Wanda Phipatanakul, MD, MS

CONTACT

857-218-5336

Wanda.Phipatanakul@childrens.harvard.edu

Claudina Luna

CONTACT

asthma@childrens.harvard.edu

Principal Investigator

Wanda Phipatanakul

PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Study Locations (Sites)

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

Atlantic Health System

Cedar Knolls, New Jersey, 07927

United States

Montefiore Einstein Clinical Research Center

Bronx, New York, 10467

United States

MetroHealth System

Cleveland, Ohio, 44109

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

Wanda Phipatanakul, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-08

Study Completion Date2027-03

Study Record Updates

Study Start Date2021-09-08

Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

Asthma