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An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

NCT03478930 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2022-04-04

Study results available
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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

  • Nasal Polyps
  • Chronic Rhinosinusitis

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2020-03-16
Completion
2020-03-16
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Mexico
  • Poland
  • Portugal
  • Russia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03478930 on ClinicalTrials.gov