Eosinophilic Chronic Rhinosinusitis Clinical Trial
Official title:
A Phase 2, Double-Blind, Placebo-Controlled Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis
| Verified date | April 2018 |
| Source | Kyowa Hakko Kirin Co., Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 63 |
| Est. completion date | March 27, 2017 |
| Est. primary completion date | March 27, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Kyowa Hakko Kirin Co., Ltd |
Japan,
Tokunaga T, Sakashita M, Haruna T, Asaka D, Takeno S, Ikeda H, Nakayama T, Seki N, Ito S, Murata J, Sakuma Y, Yoshida N, Terada T, Morikura I, Sakaida H, Kondo K, Teraguchi K, Okano M, Otori N, Yoshikawa M, Hirakawa K, Haruna S, Himi T, Ikeda K, Ishitoya J, Iino Y, Kawata R, Kawauchi H, Kobayashi M, Yamasoba T, Miwa T, Urashima M, Tamari M, Noguchi E, Ninomiya T, Imoto Y, Morikawa T, Tomita K, Takabayashi T, Fujieda S. Novel scoring system and algorithm for classifying chronic rhinosinusitis: the JESREC Study. Allergy. 2015 Aug;70(8):995-1003. doi: 10.1111/all.12644. Epub 2015 May 26. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Serum concentration of benralizumab | Pre-dose and 4, 8, 12, 16, 20, 24 days post-dose | ||
| Primary | The change from baseline in nasal polyp score at Week 12 | baseline and 12 weeks post-dose | ||
| Secondary | The change from baseline in nasal polyp score | Pre-dose and 4,8,12,16,20,24 weeks post-dose | ||
| Secondary | The change from baseline in Computed tomography (CT) score | baseline and 12 weeks post-dose | ||
| Secondary | Number of subjects discontinued from the study due to aggravation of eosinophilic chronic rhinosinusitis | Up to 24 weeks after dosing | ||
| Secondary | Time to discontinuation (days) from the study due to aggravation of eosinophilic chronic rhinosinusitis | Up to 24 weeks after dosing | ||
| Secondary | The change from baseline in Blood eosinophil count | Pre-dose and 4,8,12,16,20,24 weeks post-dose | ||
| Secondary | The change from baseline in Nasal Airway Resistance | Nasal airway resistance (Pa/cm^3/s) | Pre-dose and 4,8,12,24 weeks post-dose | |
| Secondary | The change from baseline in the averaged values of the Olfactory thresholds | Olfactory thresholds are assessed by T&T Olfactometer Test Score (Five kinds of smell with eight (5 to -2) phases). | Pre-dose and 4,8,12,24 weeks post-dose | |
| Secondary | The change from baseline in the improvement of olfactory dysfunction | Olfactory dysfunction (1 to 5) is calculated by the Olfactory thresholds. | Pre-dose and 4,8,12,24 weeks post-dose | |
| Secondary | The change from baseline in Sino-Nasal Outcome Test-2 (SNOT-22) | 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) | Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose | |
| Secondary | The change from baseline in Symptom score by Visual Analog Scale (VAS) | 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) | Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose | |
| Secondary | Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature | Up to 24 weeks after dosing |