Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
Recruiting
Phase 3Interventional Study
AsthmaEosinophilic Granulomatosis With Polyangiitis (EGPA)Hypereosinophilic Syndrome (HES)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
230 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for people who have completed a previous study with benralizumab and may benefit from continued treatment. Participants will receive benralizumab and be monitored for safety and how well it works over time.
Are You a Good Fit for This Trial?
You may be able to join if
I have signed and dated a consent form.
I completed the required treatment period of a previous study.
I agree to follow the contraception requirements.
I cannot access benralizumab commercially but need it for treatment.
You may not be able to join if
I have an ongoing health issue that stopped my treatment in the previous study.
I plan to use live vaccines.
I plan to use other biologic treatments unless no alternatives exist.
I have a medical or psychiatric condition that could affect my participation.
I am enrolled in another clinical study.
I left the previous study before completing the required treatment.
I have local access to commercially available benralizumab.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 1\. Provision of signed and dated written ICF.
2\. Participants completing minimum required OLE period of a parent study and judged by the Investigator to benefit from continued treatment.
* 3\. Participants must agree to follow the contraception requirements as per their r…
Inclusion Criteria:
* 1\. Provision of signed and dated written ICF.
2\. Participants completing minimum required OLE period of a parent study and judged by the Investigator to benefit from continued treatment.
* 3\. Participants must agree to follow the contraception requirements as per their respective parent protocols from study inclusion up to 12 weeks after the last dose of study treatment.
* 4\. Participants without childbearing potential at enrolment 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.
* 5\. Participants who are unable to access commercially available benralizumab and clinically indicated for continuation.
Exclusion Criteria:
* 1\. Ongoing, unresolved AE 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.
* 4\. Participants with any medical condition (such as cancer or viral infections \[hepatitis\]) or psychiatric condition that, in the opinion of the Investigator, could jeopardise or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments.
* 5\. Concurrently enrolled 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.
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