Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis
- Conditions
- Eosinophilic Chronic Rhinosinusitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT02772419
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
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.
- Detailed Description
Screening Period (maximum 4 weeks) , Randomized Treatment Period (24 weeks)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description benralizumab A benralizumab Subcutaneous (SC) administration Placebo Placebo Placebo SC administration benralizumab B benralizumab SC administration
- Primary Outcome Measures
Name Time Method The change from baseline in nasal polyp score at Week 12 baseline and 12 weeks post-dose
- Secondary Outcome Measures
Name Time Method The change from baseline in the improvement of olfactory dysfunction Pre-dose and 4,8,12,24 weeks post-dose Olfactory dysfunction (1 to 5) is calculated by the Olfactory thresholds.
The change from baseline in nasal polyp score Pre-dose and 4,8,12,16,20,24 weeks post-dose The change from baseline in Computed tomography (CT) score baseline and 12 weeks post-dose Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature Up to 24 weeks after dosing Number of subjects discontinued from the study due to aggravation of eosinophilic chronic rhinosinusitis Up to 24 weeks after dosing Time to discontinuation (days) from the study due to aggravation of eosinophilic chronic rhinosinusitis Up to 24 weeks after dosing The change from baseline in the averaged values of the Olfactory thresholds Pre-dose and 4,8,12,24 weeks post-dose Olfactory thresholds are assessed by T\&T Olfactometer Test Score (Five kinds of smell with eight (5 to -2) phases).
The change from baseline in Sino-Nasal Outcome Test-2 (SNOT-22) Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose Symptom score are assessed by VAS (nasal congestion, anterior and posterior nasal drip, loss of the sense of smell, headache, and impairment in activity of daily living)
The change from baseline in Blood eosinophil count Pre-dose and 4,8,12,16,20,24 weeks post-dose The change from baseline in Nasal Airway Resistance Pre-dose and 4,8,12,24 weeks post-dose Nasal airway resistance (Pa/cm\^3/s)
The change from baseline in Symptom score by Visual Analog Scale (VAS) Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose Symptom score are assessed by VAS (nasal congestion, anterior and posterior nasal drip, loss of the sense of smell, headache, and impairment in activity of daily living)