A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps (POLYP 1)
A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps (POLYP 1)
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments.
Study GA39855 (POLYP 2; NCT03280537) was another Phase III study by the Sponsor with identical objectives and design and was run in parallel with this study.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Clinical Trial of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps
Actual Study Start Date: November 15, 2017
Actual Primary Completion Date: March 11, 2019
Actual Study Completion Date: March 11, 2019
Arm:
- Experimental: Omalizumab
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Actual enrolment | 138 |
| Actual Study start date | 15 November 2017 |
| Actual Study Completion Date | 11 March 2019 |