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

  • Autoimmune Disorder
  • Nasal Polyps
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Countries
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Mexico
  • Poland
  • Portugal
  • Russia
  • Spain
  • Ukraine
  • United Kingdom
  • United States
Trial Identifier:

NCT03478930 2017-003450-16 WA40169

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT03478930,WA40169,2017-003450-16 Trial Identifier
      Omalizumab, Placebo Treatments
      Nasal Polyps, Chronic Rhinosinusitis Condition
      Official Title

      Open-Label Extension Study of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 75 Years Age
      No Healthy Volunteers
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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