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

Primary Purpose

Eosinophilic Chronic Rhinosinusitis

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

benralizumab

Placebo

About this trial

This is an interventional treatment trial for Eosinophilic Chronic Rhinosinusitis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

benralizumab A

benralizumab B

Placebo

Arm Description

Subcutaneous (SC) administration

SC administration

Placebo SC administration

Outcomes

Primary Outcome Measures

The change from baseline in nasal polyp score at Week 12

Secondary Outcome Measures

The change from baseline in nasal polyp score

The change from baseline in Computed tomography (CT) score

Number of subjects discontinued from the study due to aggravation of eosinophilic chronic rhinosinusitis

Time to discontinuation (days) from the study due to aggravation of eosinophilic chronic rhinosinusitis

The change from baseline in Blood eosinophil count

The change from baseline in Nasal Airway Resistance

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

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).

The change from baseline in the improvement of olfactory dysfunction

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

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)

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)

Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature

Full Information

NCT ID

NCT02772419

First Posted

April 25, 2016

Last Updated

April 20, 2018

Sponsor

Kyowa Kirin Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02772419

Brief Title

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

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

March 27, 2017 (Actual)

Study Completion Date

March 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kyowa Kirin Co., Ltd.

4. Oversight

Data Monitoring Committee

5. 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eosinophilic Chronic Rhinosinusitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

benralizumab A

Arm Type

Experimental

Arm Description

Subcutaneous (SC) administration

Arm Title

benralizumab B

Arm Type

Experimental

Arm Description

SC administration

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo SC administration

Intervention Type

Drug

Intervention Name(s)

benralizumab

Intervention Description

SC administration

Intervention Type

Drug

Intervention Name(s)

benralizumab

Intervention Description

SC administration

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

SC administration

Primary Outcome Measure Information:

Title

The change from baseline in nasal polyp score at Week 12

Time Frame

baseline and 12 weeks post-dose

Secondary Outcome Measure Information:

Title

The change from baseline in nasal polyp score

Time Frame

Pre-dose and 4,8,12,16,20,24 weeks post-dose

Title

The change from baseline in Computed tomography (CT) score

Time Frame

baseline and 12 weeks post-dose

Title

Number of subjects discontinued from the study due to aggravation of eosinophilic chronic rhinosinusitis

Time Frame

Up to 24 weeks after dosing

Title

Time to discontinuation (days) from the study due to aggravation of eosinophilic chronic rhinosinusitis

Time Frame

Up to 24 weeks after dosing

Title

The change from baseline in Blood eosinophil count

Time Frame

Pre-dose and 4,8,12,16,20,24 weeks post-dose

Title

The change from baseline in Nasal Airway Resistance

Description

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

Time Frame

Pre-dose and 4,8,12,24 weeks post-dose

Title

The change from baseline in the averaged values of the Olfactory thresholds

Description

Olfactory thresholds are assessed by T&T Olfactometer Test Score (Five kinds of smell with eight (5 to -2) phases).

Time Frame

Pre-dose and 4,8,12,24 weeks post-dose

Title

The change from baseline in the improvement of olfactory dysfunction

Description

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

Time Frame

Pre-dose and 4,8,12,24 weeks post-dose

Title

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

Description

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)

Time Frame

Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose

Title

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

Description

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)

Time Frame

Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose

Title

Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature

Time Frame

Up to 24 weeks after dosing

Other Pre-specified Outcome Measures:

Title

Serum concentration of benralizumab

Time Frame

Pre-dose and 4, 8, 12, 16, 20, 24 days post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Facility Information:

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25945591

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.

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

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