NCT03280550

A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Clinical Trial of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Nasal Polyps
• Chronic Rhinosinusitis

Interventions

Type	Name	Description
DRUG	Omalizumab	Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table.
DRUG	Placebo	Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table.

Timeline

• Start date: 2017-11-15
• Primary completion: 2019-03-11
• Completion: 2019-03-11
• First posted: 2017-09-12
• Last updated: 2020-03-23
• Results posted: 2020-03-23

Locations

37 sites across 10 countries: United States, Canada, Czechia, Germany, Mexico, Poland, Portugal, Russia, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study