Eosinophilic Chronic Rhinosinusitis
Conditions
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)
Interventions
DRUGbenralizumab
SC administration
DRUGPlacebo
SC administration
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in nasal polyp score at Week 12 | baseline and 12 weeks post-dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 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 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 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 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 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) |
| Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature | Up to 24 weeks after dosing | — |
Other
| Measure | Time frame |
|---|---|
| Serum concentration of benralizumab | Pre-dose and 4, 8, 12, 16, 20, 24 days post-dose |
Countries
Japan
Outcome results
None listed