Testing Benralizumab for asthma
Official title: Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
ROSY-F: Roll-Over Study for Participants Who Have Completed a Previous Study With Benralizumab (Fasenra) and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
- Phase 3
- 1 group
- Sites in Hamilton and Toronto
- Recruiting
Interventions
- Medication
Benralizumab
Accessorized Pre-Filled Syringe (Solution for injection).
Canadian Sites (5)
1 of 5 recruiting
- Recruiting
Research Site
Toronto, Ontario
- Not yet recruiting
Research Site
Calgary, British Columbia
- Not yet recruiting
Research Site
Hamilton, Ontario
- Not yet recruiting
Research Site
Toronto, Ontario
- Not yet recruiting
Research Site
Toronto, Ontario
Eligibility Criteria
See who this study is looking for12 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +1\. Provision of signed and dated written ICFInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +\. Participants completing minimum required OLE period of a parent study and judged by the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → to benefit from continued treatment.
- +5\. Participants who are unable to access commercially available benralizumab and clinically indicated for continuation.
- +3\. Participants must agree to follow the contraception requirements as per their respective parent protocols from study inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → up to 12 weeks after the last dose of study treatment.
- +4\. Participants without childbearing potential at enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → must agree to start appropriate contraception if childbearing potential develops during the study and up to 12 weeks after the last dose of study treatment.
Exclusion
- −4\. Participants with any medical condition (such as cancer or viral infections \[hepatitis\]) or psychiatric condition that, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, could jeopardise or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocolProtocolThe detailed plan a study must follow.Read more → required assessments.
- −1\. Ongoing, unresolved AEAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting benralizumab.
- −2\. Participants who are planning to use live/live-attenuated vaccines.
- −3\. Participants who are planning to use biologic therapies, including B-cell therapies with the exception for the treatment of co-morbidities where no alternative medicine is available.
- −5\. Concurrently enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in any clinical study (other than a parent study).
- −6\. Participants who discontinued the parent study prior to completing the minimum OLE or treatment period.
- −7\. Local access to commercially available benralizumab.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Benralizumab.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 6 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 230 people.
The study is currently expected to finish around January 2030.
The main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → until 8 weeks after the last dose of benralizumab.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Safety will be evaluated by monitoring and assessing SAEs and non-serious AEs reported throughout the study and until 8 weeks after the last dose of benralizumab — measured over From baselineBaselineYour starting measurements, taken before treatment begins.Read more → until 8 weeks after the last dose of benralizumab.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07444567 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About BenralizumabDrug
Accessorized Pre-Filled Syringe (Solution for injection).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 6 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 6 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → until 8 weeks after the last dose of benralizumab.
The study as a whole is currently expected to finish around 2030-01-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 230 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 5 locations, including: Calgary, British Columbia, Canada; Hamilton, Ontario, Canada; Toronto, Ontario, Canada; Ann Arbor, Michigan, United States; The Bronx, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The rationale of the roll-over study (ROSY) is to provide continuous access to study treatment for participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment, as judged by the Investigator, while monitoring long-term safety and tolerability of benralizumab.
Other Sites (2)
Research Site
Ann Arbor, Michigan, United States
Research Site
The Bronx, New York, United States
Think this trial might be right for you?
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.