Clinical trial NCT02772419: Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis
Official title: A Phase 2, Double-Blind, Placebo-Controlled Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eosinophilic Chronic Rhinosinusitis
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-05-13
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: The change from baseline in nasal polyp score at Week 12
timeFrame: baseline and 12 weeks post-dose
Secondary outcomes:
measure: The change from baseline in nasal polyp score
timeFrame: Pre-dose and 4,8,12,16,20,24 weeks post-dose
measure: The change from baseline in Computed tomography (CT) score
timeFrame: baseline and 12 weeks post-dose
measure: Number of subjects discontinued from the study due to aggravation of eosinophilic chronic rhinosinusitis
timeFrame: Up to 24 weeks after dosing
measure: Time to discontinuation (days) from the study due to aggravation of eosinophilic chronic rhinosinusitis
timeFrame: Up to 24 weeks after dosing
measure: The change from baseline in Blood eosinophil count
timeFrame: Pre-dose and 4,8,12,16,20,24 weeks post-dose
measure: The change from baseline in Nasal Airway Resistance
timeFrame: Pre-dose and 4,8,12,24 weeks post-dose
measure: The change from baseline in the averaged values of the Olfactory thresholds
timeFrame: Pre-dose and 4,8,12,24 weeks post-dose
measure: The change from baseline in the improvement of olfactory dysfunction
timeFrame: Pre-dose and 4,8,12,24 weeks post-dose
measure: The change from baseline in Sino-Nasal Outcome Test-2 (SNOT-22)
timeFrame: Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose
measure: The change from baseline in Symptom score by Visual Analog Scale (VAS)
timeFrame: Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose
measure: Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature
timeFrame: Up to 24 weeks after dosing
Other outcomes:
measure: Serum concentration of benralizumab
timeFrame: Pre-dose and 4, 8, 12, 16, 20, 24 days post-dose
Locations:
city: Tokyo
country: Japan
Study officials:
References:
citation: 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.