AsthmaPhase 3ARIANCT02821416

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

A Phase 3 study testing Benralizumab in people with Asthma, run by AstraZeneca at 6 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma
What is being tested?: Benralizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 6 sitesCanada
Study dates: 11 Oct 2016to 22 Oct 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Canada6 sites

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

Other trials in Canada

About this study

Official title: 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

Read the 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.

Conditions: Asthma
Being tested: Benralizumab, Placebo
Keywords: asthma
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BenralizumabBiological
Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive
PlaceboOther
Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive

Study groups in NCT02821416
Study group	Role	What they receive
Benralizumab	Experimental	Benralizumab administered subcutaneously Receives: Biological: Benralizumab
Placebo	Placebo comparator	Placebo administered subcutaneously Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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)
Measured: From prechallenge to 3 to 7 hours post allergen challenge during week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 201622 Oct 2019

First posted1 Jul 2016 (estimated)
Study start11 Oct 2016
Primary completion22 Oct 2019
Study completion22 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02821416
Sponsor's protocol ID: D3250C00040
Acronym: ARIA
Status last verified: Dec 2020
First submitted: 17 Jun 2016
Last updated: 7 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02821416
Acronym / sponsor ID: ARIA / D3250C00040
Conditions: Asthma
Keywords: asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 11 Oct 2016 (actual)
Primary completion: 22 Oct 2019 (actual)
Study completion: 22 Oct 2019 (actual)
First posted: 1 Jul 2016 (estimated)
Results: Posted 7 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Benralizumab	Experimental	Biological: BenralizumabBenralizumab administered subcutaneously
Placebo	Placebo comparator	Other: PlaceboPlacebo administered subcutaneously

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BenralizumabBenralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive	Biological	Benralizumab
PlaceboPlacebo subcutaneously on study week 0 until study week 16 day 1 inclusive	Other	Placebo

Primary outcome

Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge
Time frame: 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
Time frame: 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)

Results and safety

Results posted to the registry on 7 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Benra 30mg q.4 Week	23	20
Placebo	23	22

Primary outcome: Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge

Time frame: From prechallenge to 7 hours post allergen challenge during week 9. Mean (Standard Deviation). Unit: Percent

Measure	Benra 30mg q.4 Weeks n = 23	Placebo n = 22
Value	0.822 (4.054)	6.468 (9.560)

Benra 30mg q.4 Weeks vs Placebo: Median Difference (Final Values): -5.81 (95% CI -10.69 to -0.94), p = 0.0208, Mixed Models Analysis

Population analysed: Primary Efficacy Analysis

Primary outcome: Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge

Time frame: From prechallenge to 3 to 7 hours post allergen challenge during week 9. Mean (Standard Deviation). Unit: Percent

Measure	Benra 30mg q.4 Weeks n = 23	Placebo n = 22
Value	15.152 (8.834)	16.275 (10.235)

Benra 30mg q.4 Weeks vs Placebo: Median Difference (Final Values): 2.535 (95% CI -3.045 to 8.116), p = 0.3630, Mixed Models Analysis

Population analysed: Primary Efficacy Analysis

Adverse events

Time frame: From Visit 1a to Visit 17. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Benra 30mg q.4 Week	0 of 23 (0%)	7 of 23 (30.4%)	0 of 23
Placebo	0 of 23 (0%)	14 of 23 (60.9%)	0 of 23

Limitations and caveats (from the sponsor): This allergen challenge study was conducted in a mild, atopic asthma patient population, distinct from the current approved severe eosinophilic asthma indication.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
The CSP redacted.Link provided by the sponsor.
The SAP redacted.Link provided by the sponsor.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Benralizumab in people with Asthma, run by AstraZeneca at 6 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge (time frame: From prechallenge to 7 hours post allergen challenge during week 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02821416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.