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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: Completed Phase 4 study, sponsored by Sanofi.
NCT04998604 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 360 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The NPS was assessed by the independent physician to grade the extent/severity of nasal polyps based on evaluation by nasal endoscopy. The NPS scores for each nostril was graded based on polyp size from 0 (no polyps) to 4 (large polyps causing complete obstruction of the inferior nasal cavity). The total NPS score was calculated as the sum of right and left nostril scores and ranged from 0 (no polyps) to 8 (large polyps). Higher scores indicated more extensive or severe nasal polyps. Negative ch
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 |
What the finished NCT04998604 record still lists
NCT04998604 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04998604 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04998604's enrollment target sits among peer trials
360 225th of 2000 higher than 1,775 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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