Trials / Completed
CompletedNCT04998604
EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients
A Randomized, Double-blind, Head-to-head Comparison of Dupilumab Versus Omalizumab in Severe Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma Patients
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 360 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
Study duration per participant will be 38 weeks. The study will comprise 3 periods: 28 days ± 3 days screening and run-in period; 24 weeks Randomized investigational medicinal product (IMP) intervention period; up to 12 weeks follow-up period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dupilumab | solution for injection subcutaneous |
| DRUG | Omalizumab | solution for injection subcutaneous |
| DRUG | Placebo | solution for injection subcutaneous |
Timeline
- Start date
- 2021-09-27
- Primary completion
- 2024-10-16
- Completion
- 2024-12-27
- First posted
- 2021-08-10
- Last updated
- 2025-10-23
- Results posted
- 2025-10-23
Locations
87 sites across 17 countries: United States, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Mexico, Poland, Portugal, Romania, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04998604. Inclusion in this directory is not an endorsement.