Understanding Long-Lasting Effects of Mepolizumab in Treating Chronic Rhinosinusitis With Nasal Polyps and Exploring Its Disease-Modifying Role

What this Trial Is About

Researchers are investigating the long-lasting effects of mepolizumab in patients with chronic rhinosinusitis with nasal polyposis CRSwNP, a condition characterized by nasal polyps and severe symptoms. This study aims to understand how mepolizumab, a monoclonal antibody targeting IL-5, modifies the disease beyond eosinophil activity and to identify markers that predict which patients will have prolonged benefits after stopping treatment. The research also explores the potential role of viruses and epigenetic changes in the disease and response to therapy. Participants will receive 12 months of mepolizumab treatment given as 100 mg subcutaneous injections every 4 weeks for a total of twelve injections. The study is open-label and nonrandomized. Alongside mepolizumab, patients will continue using mometasone furoate nasal spray daily. Researchers will assess the effects before treatment, 6 months after starting treatment, and through a 12-month follow-up, using advanced molecular techniques, tissue analysis, and clinical evaluations to explore mechanisms of response and disease modification. Participants will undergo regular clinical assessments including nasal endoscopy and symptom scoring. Biological samples from nasal polyps will be collected for detailed molecular and epigenetic analysis. Researchers will monitor for persistent clinical response up to 18 months after stopping mepolizumab. Safety monitoring includes observation after injections for allergic reactions. The study will last about 18 months per participant, including treatment and follow-up periods, to evaluate long-term outcomes and identify predictors of lasting benefit.

Identifying Predictors Of Response To Mepolizumab In CRSwNP