An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
Condition: Nasal Polyps; Chronic Rhinosinusitis
MeSH terms: Sinusitis; Nasal Polyps; Polyps
Intervention: Omalizumab; Placebo
Intervention description: Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.; 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.
Intervention MeSH terms: Omalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Although this is an open-label study and all participants will be receiving omalizumab, in order to minimize bias in this study participants and the evaluating physicians will be blinded to treatment assignment of the previous studies (GA39688/GA39855) until all participants have either completed the study through the follow-up period (Week 76) or discontinued early from the study, the database is locked, and the study analyses are final.
Enrollment: 249.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to comply with the study protocol, in the investigator's judgment

          -  Participation in Study GA39688 or GA39855, including completion of endoscopy and other
             assessments at Week 24, without discontinuation of study drug

          -  Completion of eDiary daily assessments for at least 4 out of 7 days in the week prior
             to the Week 24 visit of Study GA39688 or GA39855

          -  For women of childbearing potential: agreement to remain abstinent or use acceptable
             contraceptive methods during the treatment period and for 60 days after the last dose
             of study drug

        Exclusion Criteria:

          -  Anaphylaxis/hypersensitivity related to study drug in Study GA39688 or GA39855

          -  Serious adverse events related to study drug in Study GA39688 or GA39855 that the
             investigator or Sponsor determines may jeopardize the patient's safety if he or she
             continues in the study

          -  Uncontrolled epistaxis within Study GA39688 or GA39855

          -  Pregnant or breastfeeding, or intending to become pregnant during the study or within
             60 days after the last dose of omalizumab

          -  Any serious medical condition or abnormality in clinical laboratory tests that, in the
             investigator's judgment, precludes the patient's safe participation in and completion
             of the study