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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Other: Placebo; Biological: Benralizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02821416

D3250C00040

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups, including a placebo group

Benralizumab

Experimental group

Description:

Benralizumab administered subcutaneously

Treatment:

Biological: Benralizumab

Placebo

Placebo Comparator group

Description:

Placebo administered subcutaneously

Treatment:

Other: Placebo