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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| benralizumab A | Experimental | Subcutaneous (SC) administration |
|
| benralizumab B | Experimental | SC administration |
|
| Placebo | Placebo Comparator | Placebo SC administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| benralizumab | Drug | SC administration |
| |
| benralizumab |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in nasal polyp score at Week 12 | baseline and 12 weeks post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of benralizumab | Pre-dose and 4, 8, 12, 16, 20, 24 days post-dose |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25945591 | Background | 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. |
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| ID | Term |
|---|---|
| C571386 | benralizumab |
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| Drug |
SC administration |
|
| Placebo | Drug | SC administration |
|
| 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 | Nasal airway resistance (Pa/cm^3/s) | Pre-dose and 4,8,12,24 weeks post-dose |
| 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 |
| 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 |
| 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 |
| 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 |
| Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature | Up to 24 weeks after dosing |