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

Sponsor
Kyowa Kirin Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02772419
Collaborator
(none)
63
Enrollment
1
Location
3
Arms
9.8
Actual Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Screening Period (maximum 4 weeks) , Randomized Treatment Period (24 weeks)

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Double-Blind, Placebo-Controlled Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Mar 27, 2017
Actual Study Completion Date :
Mar 27, 2017

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. The change from baseline in nasal polyp score at Week 12 [baseline and 12 weeks post-dose]

Secondary Outcome Measures

  1. The change from baseline in nasal polyp score [Pre-dose and 4,8,12,16,20,24 weeks post-dose]

  2. The change from baseline in Computed tomography (CT) score [baseline and 12 weeks post-dose]

  3. Number of subjects discontinued from the study due to aggravation of eosinophilic chronic rhinosinusitis [Up to 24 weeks after dosing]

  4. Time to discontinuation (days) from the study due to aggravation of eosinophilic chronic rhinosinusitis [Up to 24 weeks after dosing]

  5. The change from baseline in Blood eosinophil count [Pre-dose and 4,8,12,16,20,24 weeks post-dose]

  6. The change from baseline in Nasal Airway Resistance [Pre-dose and 4,8,12,24 weeks post-dose]

    Nasal airway resistance (Pa/cm^3/s)

  7. The change from baseline in the averaged values of the Olfactory thresholds [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).

  8. The change from baseline in the improvement of olfactory dysfunction [Pre-dose and 4,8,12,24 weeks post-dose]

    Olfactory dysfunction (1 to 5) is calculated by the Olfactory thresholds.

  9. The change from baseline in Sino-Nasal Outcome Test-2 (SNOT-22) [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)

  10. The change from baseline in Symptom score by Visual Analog Scale (VAS) [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)

  11. Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature [Up to 24 weeks after dosing]

Other Outcome Measures

  1. Serum concentration of benralizumab [Pre-dose and 4, 8, 12, 16, 20, 24 days post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Tokyo Japan

Sponsors and Collaborators

  • Kyowa Kirin Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02772419
Other Study ID Numbers:
  • 4563-005
First Posted:
May 13, 2016
Last Update Posted:
Apr 23, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Sinusitis
Benralizumab

Study Results

No Results Posted as of Apr 23, 2018