The protocol involves an 8-week, double-blind, placebo-controlled parallel-design trial of dupilumab in patients with AERD. Participants will have 4 total doses of dupilumab or placebo administered, with each dose administered every 2 weeks. There will be full clinical assessments and biospecimen collections at Baseline (Visit 1), Week 2 (Visit 2), and Week 8 (Visit 3).
The overall aim of the study is to determine the clinical efficacy and mechanisms of action of anti-IL-4a (dupilumab) as treatment for patients with Aspirin-Exacerbated Respiratory Disease (AERD).