Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03478930
The ClinicalTrials.gov registry entry for NCT03478930 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 249 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 67-participant average among 7 other Nasal Polyps trials with a reported enrollment target (272% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
Learn More About Clinical Trials
Similar trials for Nasal Polyps
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?
RECRUITING · NA
-
Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP
RECRUITING · Phase 4
-
Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease
ACTIVE NOT RECRUITING · Phase 2
-
Dupixent Study for Alternate Administration
ACTIVE NOT RECRUITING · Phase 4
-
Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery
COMPLETED · Phase 4
-
The Polymerase Chain Reaction (PCR) Analysis of Nasal Polyps for Fungal DNA
COMPLETED · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.