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NCT04998604 · ClinicalTrials.gov registry record · Phase 4
EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 360
- Enrollment target
NCT04998604 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 360 participants.
The verdict
NCT04998604, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 360 participants
- Enrollment target
Study 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
Interventions
- DRUG Placebo
- DRUG Dupilumab
- DRUG Omalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2021-09-27 |
| Est. Completion | 2024-12-27 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04998604
The ClinicalTrials.gov registry entry for NCT04998604 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04998604 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04998604 about?
NCT04998604 is a clinical study titled "EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients". 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 omali...
What is the current status of trial NCT04998604?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 360 participants. The study started on 2021-09-27. Estimated completion is 2024-12-27.
What interventions are being tested in trial NCT04998604?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG), Omalizumab (DRUG).
Who is sponsoring clinical trial NCT04998604?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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