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NCT03478930 · ClinicalTrials.gov registry record · Phase 3
An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
A Phase 3 study of Nasal Polyps and Chronic Rhinosinusitis, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 249
- Enrollment target
- 20
- Study locations
NCT03478930: Completed Phase 3 study of Nasal Polyps and Chronic Rhinosinusitis, sponsored by Hoffmann-La Roche.
NCT03478930 is a Phase 3 study of Nasal Polyps and Chronic Rhinosinusitis that has completed, run by Hoffmann-La Roche. The registered enrollment target is 249 participants, above the 67-participant average among 7 other Nasal Polyps trials with a reported enrollment target (272% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03478930, a Phase 3 study of Nasal Polyps and Chronic Rhinosinusitis, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 249 participants
- Enrollment target
- 20
- Study locations
Study Summary
The overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult participants with chronic rhinosinusitis with nasal polyps who completed the double-blind, placebo-controlled, Phase III studies GA39688 (NCT03280550) or GA39855 (NCT03280537). Participants will be eligible for enrollment in the study at, or within 28 days after, the Week 24 visit of Studies GA39688/GA39855. After enrollment into this open-label extension (OLE) study, participants will receive 28 weeks of dosing of omalizumab before entering a 24-week off-treatment observation phase of the study. Baseline in this OLE study is defined as the last pre-treatment measurement prior to randomization in Studies GA39688/GA39855 (i.e., baseline of Studies GA39688/GA39855). The data that will be reported from baseline to Week 24 inclusive will come from Studies GA39688/GA39855.
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Omalizumab
Study Locations (20)
California
- Jonathan Corren MD, Inc. - Los Angeles
- The Allergy Station at Sacramento ENT - Roseville
- Bensch Clinical Research LLC - Stockton
Florida
- Specialist Global Research - Hialeah
- Vitae Research Center - Miami
- University of South Florida - Tampa
Maryland
- Chesapeake Clinical Research Inc - CRN - Baltimore
- Institute for Asthma & Allergy - Chevy Chase
New York
- Northwell Health - Great Neck
- Montefiore Medical Center - The Bronx
Alabama
- Clinical Research Center of Alabama, LLC - Birmingham
Arizona
- Banner University of Arizona Medical Center - Tucson
Colorado
- Colorado ENT & Allergy - Colorado Springs
Idaho
- Asthma & Allergy of Idaho - Twin Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2018-05-09 |
| Est. Completion | 2020-03-16 |
| Phase | Phase 3 |
What the finished NCT03478930 record still lists
NCT03478930 is an interventional study that assigns participants to a tested intervention. The registered 249 participants enrollment target is mid-sized for trials with a published cap, above the 67-participant average among 7 other Nasal Polyps trials with a reported enrollment target (272% higher).
The record links to 2 conditions, with Nasal Polyps appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03478930 names 20 study sites across 14 states, led by California, Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT03478930 about?
NCT03478930 is a clinical study titled "An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps". The overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult participants with chronic rhinosinusitis with nasal polyps who completed the double-blind, placebo-controlled, Phase III studies GA39688 (NCT03280550) or ...
What is the current status of trial NCT03478930?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 249 participants. The study started on 2018-05-09. Estimated completion is 2020-03-16.
What conditions does trial NCT03478930 study?
This clinical trial studies the following conditions: Nasal Polyps, Chronic Rhinosinusitis.
What interventions are being tested in trial NCT03478930?
The interventions under investigation include: Placebo (DRUG), Omalizumab (DRUG).
Who is sponsoring clinical trial NCT03478930?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03478930 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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