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

Kyowa Kirin

Status and phase: Completed; Phase 2

Conditions: Eosinophilic Chronic Rhinosinusitis

Treatments: Drug: Placebo; Drug: benralizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02772419

4563-005

Details and patient eligibility

About

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.

Full description

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

Enrollment: 63 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 3 patient groups, including a placebo group

benralizumab A

Experimental group

Description:

Subcutaneous (SC) administration

Treatment:

Drug: benralizumab

Drug: benralizumab

benralizumab B

Experimental group

Description:

SC administration

Treatment:

Drug: benralizumab

Drug: benralizumab

Placebo

Placebo Comparator group

Description:

Placebo SC administration

Treatment:

Drug: Placebo