Open-Label Extension Study of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps
Open-Label Extension Study of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps
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.
Inclusion Criteria:
Exclusion Criteria:
Aveiro, 3814-501, Portugal
Moscow, Moscow Oblast 121356, Russia
Smolensk, Moscow Oblast 214031, Russia
Santiago de Compostela, LA Coruña 15706, Spain
Kharkiv, Kharkiv Governorate 61166, Ukraine
Poltava, Poltava Governorate 36024, Ukraine