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CompletedNCT02772419Updated Apr 23, 2018

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

A Phase 2 interventional study of benralizumab and benralizumab in Eosinophilic Chronic Rhinosinusitis, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-23.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Eosinophilic Chronic Rhinosinusitis
03

In context

Rhinosinusitis

330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.

This study's enrollment of 63 is close to the median of 60 across 227 interventional studies indexed under Rhinosinusitis.

Browse Rhinosinusitis studies →

Lead sponsor

Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    benralizumab A

    Subcutaneous (SC) administration

    Drug: benralizumab

  • Experimental
    benralizumab B

    SC administration

    Drug: benralizumab

  • Placebo comparator
    Placebo

    Placebo SC administration

    Drug: Placebo

Interventions

  • Drugbenralizumab

    SC administration

  • Drugbenralizumab

    SC administration

  • DrugPlacebo

    SC administration

06

What researchers measure

Primary outcomes

  1. The change from baseline in nasal polyp score at Week 12

    Time frame: baseline and 12 weeks post-dose

Secondary outcomes

  1. The change from baseline in nasal polyp score

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

  2. The change from baseline in Computed tomography (CT) score

    Time frame: baseline and 12 weeks post-dose

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

    Time frame: Up to 24 weeks after dosing

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

    Time frame: Up to 24 weeks after dosing

  5. The change from baseline in Blood eosinophil count

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

  6. The change from baseline in Nasal Airway Resistance

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

    Time frame: Pre-dose and 4,8,12,24 weeks post-dose

  7. 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).

    Time frame: Pre-dose and 4,8,12,24 weeks post-dose

  8. The change from baseline in the improvement of olfactory dysfunction

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

    Time frame: Pre-dose and 4,8,12,24 weeks post-dose

  9. 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)

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

  10. 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)

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

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

    Time frame: Up to 24 weeks after dosing

Other outcomes

  1. Serum concentration of benralizumab

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

07

Study locations

1 site
  • Tokyo, Japan
08

References and documents

Publications

  • 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. PubMed 25945591 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02772419
Lead sponsor
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
May 13, 2016
Start date
Jun 2016
Primary completion
Mar 27, 2017
Completion
Mar 27, 2017
Last update
Apr 23, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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