Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis
NCT ID: NCT02772419
Last Updated: 2018-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2016-06-30
2017-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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benralizumab A
Subcutaneous (SC) administration
benralizumab
SC administration
benralizumab B
SC administration
benralizumab
SC administration
Placebo
Placebo SC administration
Placebo
SC administration
Interventions
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benralizumab
SC administration
benralizumab
SC administration
Placebo
SC administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Tokyo, , Japan
Countries
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References
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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.
Other Identifiers
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4563-005
Identifier Type: -
Identifier Source: org_study_id
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