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Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Kyowa Hakko Kirin Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier:
NCT02772419
First received: April 25, 2016
Last updated: December 6, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Eosinophilic Chronic Rhinosinusitis
Drug: benralizumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Placebo-Controlled Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis

Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:
  • The change from baseline in nasal polyp score at Week 12 [ Time Frame: baseline and 12 weeks post-dose ]

Secondary Outcome Measures:
  • The change from baseline in nasal polyp score [ Time Frame: Pre-dose and 4,8,12,16,20,24 weeks post-dose ]
  • The change from baseline in Computed tomography (CT) score [ Time Frame: baseline and 12 weeks post-dose ]
  • Number of subjects discontinued from the study due to aggravation of eosinophilic chronic rhinosinusitis [ Time Frame: Up to 24 weeks after dosing ]
  • Time to discontinuation (days) from the study due to aggravation of eosinophilic chronic rhinosinusitis [ Time Frame: Up to 24 weeks after dosing ]
  • The change from baseline in Blood eosinophil count [ Time Frame: Pre-dose and 4,8,12,16,20,24 weeks post-dose ]
  • The change from baseline in Nasal Airway Resistance [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Up to 24 weeks after dosing ]

Other Outcome Measures:
  • Serum concentration of benralizumab [ Time Frame: Pre-dose and 4, 8, 12, 16, 20, 24 days post-dose ]

Estimated Enrollment: 50
Study Start Date: May 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: benralizumab A
Subcutaneous (SC) administration
Drug: benralizumab
SC administration
Experimental: benralizumab B
SC administration
Drug: benralizumab
SC administration
Placebo Comparator: Placebo
Placebo SC administration
Drug: Placebo
SC administration

Detailed Description:
Screening Period (maximum 4 weeks) , Randomized Treatment Period (24 weeks)
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02772419

Contacts
Contact: Kyowa Hakko Kirin, Co., Ltd. clinical.info@kyowa-kirin.co.jp

Locations
Japan
Recruiting
Tokyo, Japan
Contact: Kyowa Hakko Kirin, Co., Ltd.         
Contact       clinical.info@kyowa-kirin.co.jp   
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
  More Information

Publications:
Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT02772419     History of Changes
Other Study ID Numbers: 4563-005
Study First Received: April 25, 2016
Last Updated: December 6, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 25, 2017