NCT02821416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Oct 2016

Longer than P75 for phase_3 asthma

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 11, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 7, 2021

Completed
Last Updated

January 7, 2021

Status Verified

December 1, 2020

Enrollment Period

3 years

First QC Date

June 17, 2016

Results QC Date

October 22, 2020

Last Update Submit

December 14, 2020

Conditions

Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Benralizumab

EXPERIMENTAL

Benralizumab administered subcutaneously

Biological: Benralizumab

Placebo

PLACEBO COMPARATOR

Placebo administered subcutaneously

Other: Placebo

Interventions

BenralizumabBIOLOGICAL

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

Benralizumab
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Calgary, Alberta, T2N 4Z6, Canada

Location

Research Site

Edmonton, Alberta, T6G 2B7, Canada

Location

Research Site

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Research Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Research Site

Québec, Quebec, G1V 4G5, Canada

Location

Research Site

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Limitations and Caveats

This allergen challenge study was conducted in a mild, atopic asthma patient population, distinct from the current approved severe eosinophilic asthma indication.

Results Point of Contact

Title
Maria Jison
Organization
AstraZeneca
Maria.Jison@astrazeneca.com
001-202-577-6213

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

July 1, 2016

Study Start

October 11, 2016

Primary Completion

October 22, 2019

Study Completion

October 22, 2019

Last Updated

January 7, 2021

Results First Posted

January 7, 2021

Record last verified: 2020-12

Locations

CA(6)