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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Biological: Benralizumab; Other: Placebo

• Registration Number: NCT02821416
• Lead Sponsor: AstraZeneca

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-06-17
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-07-01
• Study Start: 2016-10-11
• Primary Completion: 2019-10-22
• Study Completion: 2019-10-22
• Results First Submitted: 2020-10-22
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-14
• Last Update Submitted: 2020-12-14
• Results First Posted: 2021-01-07
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Benralizumab	Benralizumab	Benralizumab administered subcutaneously
Placebo	Placebo	Placebo administered subcutaneously

Primary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇨🇦 Quebec, Canada