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

NCT03694158 Phase 4 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Boston Children's Hospital
Phase	Phase 4
Status	ACTIVE_NOT_RECRUITING
Enrolment	150
Start date	2021-09-08
Completion	2027-03

Conditions

• Asthma

Interventions

• Dupilumab
• Placebo

Primary outcomes

• The rate of asthma exacerbations — 48 week treatment period
  An exacerbation is an asthma attack for which a clinician prescribed a course of systemic steroids, whether or not the patient took the steroids.

Countries

United States