A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps

Exclusion Criteria

• •Known history of anaphylaxis/hypersensitivity to omalizumab.
• •Treatment with investigational drugs within 12 weeks or 5 half-lives (whichever is longer) prior to screening (Day -35).
• •Treatment with monoclonal antibodies (e.g., omalizumab, mepolizumab) for 6 months prior to screening (Day -35).
• •Current treatment with leukotriene antagonists/modifiers, unless participant has been on stable dosing of such medication for at least 1 month prior to screening (Day -35).
• •Treatment with non-steroid immunosuppressants within 2 months or 5 half-lives, whichever is longer, prior to screening (Day -35).
• •Treatment with systemic corticosteroids, except when used as treatment for nasal polyposis, within 2 months prior to screening (Day -35).
• •Usage of systemic CS during the run-in period. Participants requiring systemic CS during run-in may be rescreened after completing systemic CS.
• •Treatment with intranasal CS drops or CS administering devices (e.g., OptiNose device or stents) within 1 month prior to screening (Day -35) or during the run-in period.
• •History of nasal surgery (including polypectomy) within 6 months prior to screening.
• •History of sinus or nasal surgery modifying the structure of the nose such that assessment of NPS is not possible.
• •Uncontrolled epistaxis requiring surgical or procedural intervention, including nasal packing, within 2 months prior to screening.
• •Known or suspected diagnosis of cystic fibrosis, primary ciliary dyskinesia (e.g., Kartagener syndrome) or other dyskinetic ciliary syndromes, hypogammaglobulinemia or other immune deficiency syndrome, chronic granulomatous disease and granulomatous vasculitis, granulomatosis with polyangiitis (e.g., Wegener's Granulomatosis), or eosinophilic granulomatous with polyangiitis (EGPA) (e.g., Churg-Strauss syndrome).
• •Presence of antrochoanal polyps.
• •Concomitant conditions that interfere with evaluation of primary endpoint:
• •* Nasal septal deviation occluding one or both nostrils.
• •* Ongoing rhinitis medicamentosa.
• •* Acute sinusitis, nasal infection, or upper respiratory infection during the run-in period.
• •* Known or suspected invasive or expansive fungal rhinosinusitis.
• •Known HIV infection at screening.
• •Known acute and chronic infections with hepatitis C virus (HCV) and hepatitis B virus (HBV) at screening.
• •History of myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack or a known history of a hypercoagulable disorder
• •Active tuberculosis requiring treatment within 12 months prior to screening (Day -35).
• •Initiation of or change in allergen immunotherapy within 3 months prior to screening (Day -35) or during the run-in period.
• •Initiation of or change in aspirin desensitization within 4 months prior to screening (Day -35) or during the run-in period.
• •Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab.
• •Current malignancy or history of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma that has been treated or excised and is considered resolved.
• •Any serious medical condition (including but not limited to significant arrhythmia, uncontrolled hypertension, significant pulmonary disease other than asthma) or abnormality in clinical laboratory tests that precludes the participant's safe participation in and completion of the study.
• •History of alcohol, drug, or chemical abuse within 6 months of screening.