Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis

A Phase 2, Double-Blind, Placebo-Controlled Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis

The objective of this study is to evaluate the efficacy and safety of SC administrations of Benralizumab or Placebo in the subjects with Eosinophilic Chronic Rhinosinusitis in a multicenter, randomized, double-blind, placebo-controlled study. The pharmacokinetics and immunogenicity will be assessed secondarily.

Screening Period (maximum 4 weeks) , Randomized Treatment Period (24 weeks)

Inclusion Criteria:

• Patients 20 years to 75 years of age
• Eosinophilic chronic rhinosinusitis with a total score of ≥ 11 according to the diagnosis of eosinophilic chronic rhinosinusitis at enrollment
• A minimum bilateral nasal polyp score of 3 out of the maximum score of 8 (with a score of at least 1 out of the maximum score of 4 for each nostril) at screening and at enrollment
• Weight of ≥ 40 kg at screening

Exclusion Criteria:

• A Sino-Nasal Outcome Test-22 (SNOT-22) score of < 7 at enrollment
• Any nasal surgery (including polypectomy) within 1 year prior to the date of consent
• Hospitalization for ≥ 24 hours for treatment of asthma exacerbation, within 12 weeks prior to the date of consent
• Exposure to any commercially available (e.g., omalizumab) or investigational biologic agent within 16 weeks or 5 half-lives prior to enrollment, whichever is longer
• Use of systemic corticosteroids (including oral corticosteroids) or corticosteroid nasal solution (except spraying) within 4 weeks prior to enrollment or planned use of such medications during the double-blind period
• Prior treatment with benralizumab