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NCT03280537 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 127
- Enrollment target
NCT03280537: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT03280537 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 127 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03280537, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 127 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments. Study GA39688 (POLYP 1; NCT03280550) was another Phase III study by the Sponsor with identical objectives and design and was run in parallel with this study.
Primary Outcome
Total NPS ranges from 0 to 8 (sum of 0-4 for left and right nasal passage scores per the following criteria), with a lower score indicating smaller-sized nasal polyps: 0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; 2 = Polyps reaching below the lower border of the middle turbinate (modified to accommodate those with a middle turbinectomy, such that polyp must have reached the top of the inferior turbinate.); 3 = Large polyps r
Interventions
- DRUG Placebo
- DRUG Omalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2017-11-21 |
| Est. Completion | 2019-03-07 |
| Phase | Phase 3 |
What the finished NCT03280537 record still lists
NCT03280537 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03280537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03280537 about?
NCT03280537 is a clinical study titled "A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps". The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments. Study GA39688 (POLYP 1; NCT03280550) was another Phase I...
What is the current status of trial NCT03280537?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 127 participants. The study started on 2017-11-21. Estimated completion is 2019-03-07.
What interventions are being tested in trial NCT03280537?
The interventions under investigation include: Placebo (DRUG), Omalizumab (DRUG).
Who is sponsoring clinical trial NCT03280537?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03280537's enrollment target sits among peer trials
127 1602nd of 2000 higher than 398 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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