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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Biological: Benralizumab; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Research Site
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Research Site
    • Edmonton, Alberta, Canada, T6G 2B7
      • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Research Site
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Research Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered subcutaneously	Other: Placebo; Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive
Experimental: Benralizumab; Benralizumab administered subcutaneously	Biological: Benralizumab; Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• The CSP redacted.
• The SAP redacted.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2016
• Primary Completion (Actual): October 22, 2019
• Study Completion (Actual): October 22, 2019

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Actual): January 7, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: asthma
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Anti-Asthmatic Agents; Respiratory System Agents; Benralizumab
• Other Study ID Numbers: D3250C00040