An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
Status:
Completed
Trial end date:
2020-03-16
Target enrollment:
Participant gender:
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.