Trials / Completed
CompletedNCT03478930
An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
Open-Label Extension Study of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 249 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omalizumab | Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W. |
| DRUG | Placebo | Participants will not be receiving placebo in this OLE study. Participants who were randomized to the placebo arms for 24 weeks in studies GA39688/GA39855 and then enter this OLE study will receive omalizumab, but they will be placed in separate analysis cohorts. |
Timeline
- Start date
- 2018-05-09
- Primary completion
- 2020-03-16
- Completion
- 2020-03-16
- First posted
- 2018-03-27
- Last updated
- 2022-04-04
- Results posted
- 2021-05-11
Locations
79 sites across 14 countries: United States, Belgium, Canada, Czechia, France, Germany, Hungary, Mexico, Poland, Portugal, Russia, Spain, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03478930. Inclusion in this directory is not an endorsement.