NCT02772419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2017

Completed
Last Updated

April 23, 2018

Status Verified

April 1, 2018

Enrollment Period

10 months

First QC Date

April 25, 2016

Last Update Submit

April 20, 2018

Conditions

Eosinophilic Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

  • The change from baseline in nasal polyp score at Week 12

    baseline and 12 weeks post-dose

Secondary Outcomes (11)

  • The change from baseline in nasal polyp score

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

  • The change from baseline in Computed tomography (CT) score

    baseline and 12 weeks post-dose

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

    Up to 24 weeks after dosing

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

    Up to 24 weeks after dosing

  • The change from baseline in Blood eosinophil count

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

  • +6 more secondary outcomes

Other Outcomes (1)

  • Serum concentration of benralizumab

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

Study Arms (3)

benralizumab A

EXPERIMENTAL

Subcutaneous (SC) administration

Drug: benralizumab

benralizumab B

EXPERIMENTAL

SC administration

Drug: benralizumab

Placebo

PLACEBO COMPARATOR

Placebo SC administration

Drug: Placebo

Interventions

benralizumabDRUG

SC administration

benralizumab A
PlaceboDRUG

SC administration

Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 25945591BACKGROUND

MeSH Terms

Interventions

benralizumab

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

May 13, 2016

Study Start

June 1, 2016

Primary Completion

March 27, 2017

Study Completion

March 27, 2017

Last Updated

April 23, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)