Comparing Biologic Treatments for Chronic Sinusitis with Nasal Polyps A Phase 4 Study to Identify the Best Biologic and Predict Patient Response

What this Trial Is About

Chronic Sinusitis with Nasal Polyps CRSwNP affects about 4% of people in the United States, totaling over 13 million individuals. This study evaluates three FDA-approved biologic medicationsdupilumab, omalizumab, and mepolizumabto determine if any one biologic provides better outcomes than the others and whether baseline biomarkers can predict which patients will respond best to these treatments. The trial addresses the current challenge clinicians face in selecting the most suitable biologic therapy for each patient with CRSwNP. Participants will receive one of the three biologic agents under study, with treatment planned as part of a randomized, parallel design. The biologics have shown efficacy in prior phase III trials but vary in patient response. The study aims to gather evidence to compare these medications directly in patients who have elected to undergo biologic therapy for CRSwNP. Patients must have been treated with intranasal corticosteroids prior to enrollment and be capable of receiving all three biologics. During the study, participants will be monitored for disease-specific quality of life over 24 weeks. Assessments will include clinical evaluations aligned with CRSwNP criteria and symptom scoring. Data collected will help determine the relative benefit of each biologic and identify factors predicting response. The study is sponsored by the Medical University of South Carolina and will continue through February 2030, with ongoing data collection and participant follow-up throughout this period.

Biologics in Chronic Rhinosinusitis With Nasal Polyposis