drugset / Trial / NCT04998604

EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients

NCT04998604

Phase 4 Completed 360 enrolled Sanofi Regeneron Pharmaceuticals · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

Primary Objective -To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell Secondary Objectives * To evaluate the efficacy of dupilumab in improving chronic rhinosinusitis with nasal polyps (CRSwNP) symptoms at Week 24 compared to omalizumab * To evaluate the efficacy of dupilumab in improving CRSwNP total symptom score (TSS) at Week 24 compared to omalizumab * To evaluate the effect of dupilumab on health related quality of life (HRQoL) at week 24 compared to omalizumab * To evaluate the efficacy of dupilumab in improving nasal peak inspiratory flow at Week 24 compared to omalizumab * To evaluate the effect of dupilumab on CRSwNP overall disease severity at Week 24 compared to omalizumab * To evaluate the safety of dupilumab and omalizumab

Timeline

Start
2021-09-27
Primary completion
2024-10-16
Completion
2024-12-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Dupilumab Monoclonal antibody 300 mg Subcutaneous
Subject Omalizumab Monoclonal antibody 75 mg Subcutaneous
Subject Omalizumab Monoclonal antibody 600 mg Subcutaneous