Study of Stopping or Continuing Mepolizumab or Dupilumab Treatment in Adults With Controlled Nasal Polyps

What this Trial Is About

Researchers are evaluating whether patients with severe chronic rhinosinusitis with nasal polyps, who have been successfully treated with biologic therapies Mepolizumab or Dupilumab and have been symptom-free for at least a year, can safely stop their biologic treatment without the disease returning. This randomized controlled trial aims to find out how many patients remain in complete remission after stopping treatment and to compare if one of the two biologic drugs is more likely to maintain remission. The study follows Danish guidelines recommending trial cessation of biologics after two years of well-controlled disease. Participants are randomly assigned to one of two groups one group continues their biologic treatment with either Dupilumab or Mepolizumab every four weeks, while the other group stops their biologic treatment completely at the start of the study. The study lasts for 52 weeks for each participant. If symptoms return or patients feel their disease is partly uncontrolled, those who stopped treatment will restart the same biologic at the previous dose and interval. The trial is open-label, meaning both participants and investigators know the treatment assignments. Throughout the study, participants will be monitored at baseline and at 12, 26, 38, and 52 weeks to assess if their nasal and sinus symptoms recur. Participants can also contact the research team anytime if symptoms reappear. The main outcome measured is the number of patients who remain in complete remission without biologic treatment after one year. Secondary outcomes include differences between the two biologics regarding remission maintenance. No additional tests or procedures beyond usual care are added, and safety monitoring is included to ensure quick intervention if needed.

Complete Remission After Treatment With Biologics for Nasal Polyps