drugset / Trial / NCT05942222

A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps

NCT05942222

Phase 4 Active not recruiting 220 enrolled Rigshospitalet, Denmark
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this randomized clinical trial is to compare the effects of two newly available biological drugs for the treatment of severe chronic rhinosinusitis with nasal polyps in Danish patients. The main questions it aims to answer are whether the two drugs are comparable in effect after 24 weeks in terms of: * A subjective score (the SNOT-22) * An objective score, i.e.the physician-assessed score of nasal polyp size (the Nasal Polyp Score (0-8)) Methods: Participants will be randomized to receive one of the IMPs drug in the standard dose. After 24 weeks the effect is assessed by subjective and objective measures. If the criteria set by the Danish Medicinal Council are met (see elsewhere), treatment continues with the same drug for an additional 24 weeks. If the effect criteria are not met, the subject crosses-over to the opposite drug for an additional 24 weeks. After 48 weeks the effect is assessed once more.

Timeline

Start
2023-04-27
Primary completion
2026-04-01
Completion
2026-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dupilumab Monoclonal antibody 300 mg Subcutaneous
Comparator Mepolizumab Monoclonal antibody 100 mg Subcutaneous