An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
Public ClinicalTrials.gov record NCT03478930. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open-Label Extension Study of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03478930
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 249 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 9, 2018 (Actual)
- Primary completion
- Mar 16, 2020 (Actual)
- Completion
- Mar 16, 2020 (Actual)
- Last update posted
- Apr 4, 2022
2018 – 2020
United States locations
- U.S. sites
- 25
- U.S. states
- 18
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Center of Alabama, LLC | Birmingham | Alabama | 35209 | — |
| Banner University of Arizona Medical Center | Tucson | Arizona | 85724 | — |
| Jonathan Corren MD, Inc. | Los Angeles | California | 90025 | — |
| The Allergy Station at Sacramento ENT | Roseville | California | 95661 | — |
| Bensch Clinical Research LLC | Stockton | California | 95207 | — |
| Colorado ENT & Allergy | Colorado Springs | Colorado | 80909 | — |
| Specialist Global Research | Hialeah | Florida | 33012 | — |
| Vitae Research Center | Miami | Florida | 33135 | — |
| University of South Florida | Tampa | Florida | 33613 | — |
| Asthma & Allergy of Idaho | Twin Falls | Idaho | 83301 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Tandem Clinical Research, LLC | Marrero | Louisiana | 70072 | — |
| Chesapeake Clinical Research Inc - CRN | Baltimore | Maryland | 21236 | — |
| Institute for Asthma & Allergy | Chevy Chase | Maryland | 20815 | — |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | — |
| University of Missouri Health Care System | Columbia | Missouri | 65212 | — |
| Northwell Health | Great Neck | New York | 11021 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Vital Prospects Clinical Research Institute PC - CRN | Tulsa | Oklahoma | 74136 | — |
| Allergy Associates Research Center LLC - CRN | Portland | Oregon | 97202 | — |
| Medical University of South Carolina Hospital | Charleston | South Carolina | 29425 | — |
| TTS Research | Boerne | Texas | 78006 | — |
| Allergy & Asthma Res Ctr PA | San Antonio | Texas | 78251 | — |
| Chrysalis Clinical Research | St. George | Utah | 84790 | — |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 54 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03478930, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 4, 2022 · Synced Nov 2, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03478930 live on ClinicalTrials.gov.