Continued benralizumab for participants who completed a prior benralizumab study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, non-randomized, multicenter international study designed to provide continued access to benralizumab for participants who completed or exited a parent trial and are judged by the investigator to still benefit. Eligible participants will be offered transition to ROSY-F, with ongoing safety and tolerability monitoring while treatment continues. The study focuses on indications including asthma, EGPA, and HES, and may enroll participants from current or future parent studies. Treatment with benralizumab will be provided as long as clinical benefit is observed and access remains appropriate. Key elements include continued treatment with benralizumab and ongoing safety assessments in a real-world, post-parent-study setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Buenos Aires, Argentina Recruiting
• Research Site
  Florida, Argentina Recruiting
• Research Site
  Mar del Plata, Argentina Recruiting
• Research Site
  Mendoza, Argentina Recruiting
• Research Site
  Mendoza, Argentina Recruiting
• Research Site
  Rosario, Argentina Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.