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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-11

Study Completion Date

2019-10-22

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.

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Benralizumab

Benralizumab administered subcutaneously

Group Type EXPERIMENTAL

Benralizumab

Intervention Type BIOLOGICAL

Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive

Placebo

Placebo administered subcutaneously

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive

Interventions

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Benralizumab

Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive

Intervention Type BIOLOGICAL

Placebo

Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Provision of informed consent prior to any study specific procedures
2. Female or male aged 18 to 65 years, inclusively, at the time of enrolment.
3. General good health
4. Mild, stable, allergic asthma and asthma therapy limited to inhaled, short-acting beta 2 agonists (not more than twice weekly)
5. Positive skin-prick test to at least one common aeroallergen

Exclusion Criteria

1. Current lung disease other than mild allergic asthma
2. Any history or symptoms of disease, including, but not limited to, cardiovascular, neurologic, autoimmune or haematologic
3. Any clinically significant abnormal findings in laboratory test results in complete blood count, coagulation, chemistry panel and urinalysis at enrolment and during screening period
4. History of anaphylaxis to any biologic therapy or vaccine

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No