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Completed

NCT Number: NCT02772419

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

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.

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Key information

Conditions

Eosinophilic Chronic Rhinosinusitis

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benralizumab

Drug

SC administration

Placebo

Drug

SC administration

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

    Time frame: 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

    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).

  8. 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.

  9. 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)

  10. 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)

  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

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

A Phase 2, Double-Blind, Placebo-Controlled Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 13, 2016
Registry last updated
Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.