Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics

Study Overview
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Brief Summary
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This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks on allergen-induced inflammation in subjects with mild atopic asthma challenged with an inhaled allergen.

Detailed Description
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This randomized, double-blind, parallel group, placebo-controlled study will evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks for 3 doses on allergen-induced inflammation in subjects with mild atopic asthma challenged with an inhaled allergen. Approximately 38 non-smoking men and women (18 - 65 years of age) corticosteroid-free (oral and inhaled) mild, atopic asthmatics who have demonstrated a dual (early and late) asthmatic response to inhaled allergen challenge at screening will be recruited to complete the study.

Official Title
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A Double-Blind, Randomized, Parallel Group, Placebo-Controlled Multi-Centre Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics

Conditions
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Asthma

Intervention / Treatment
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* Biological: Benralizumab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures Female or male aged 18 to 65 years, inclusively, at the time of enrolment. General good health Mild, stable, allergic asthma and asthma therapy limited to inhaled, short-acting beta 2 agonists (not more than twice weekly) Positive skin-prick test to at least one common aeroallergen Exclusion Criteria: Current lung disease other than mild allergic asthma Any history or symptoms of disease, including, but not limited to, cardiovascular, neurologic, autoimmune or haematologic Any clinically significant abnormal findings in laboratory test results in complete blood count, coagulation, chemistry panel and urinalysis at enrolment and during screening period History of anaphylaxis to any biologic therapy or vaccine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Benralizumab<br>Benralizumab administered subcutaneously | Biological: Benralizumab<br>* Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive<br>|
| Placebo Comparator: Placebo<br>Placebo administered subcutaneously | Other: Placebo<br>* Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge | To evaluate the effect of benralizumab on allergen-induced increases in eosinophils in induced sputum | From prechallenge to 7 hours post allergen challenge during week 9 | 
| Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge | To evaluate the effect of benralizumab on the allergen-induced late (3-7 hours post challenge) asthmatic response (LAR) | From prechallenge to 3 to 7 hours post allergen challenge during week 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma