Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Provision of signed and dated written ICF.
  • Participants completing minimum required OLE period of a parent study and judged by the Investigator to benefit from continued treatment.
• 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.
• 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.
• Participants who are unable to access commercially available benralizumab and clinically indicated for continuation.

🚫 You may not be able to join if…

• 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.
• Participants who are planning to use live/live-attenuated vaccines.
• 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.
• 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.
• Concurrently enrolled in any clinical study (other than a parent study).
• Participants who discontinued the parent study prior to completing the minimum OLE or treatment period.
• Local access to commercially available benralizumab.

Where this trial is running

• Research Site, Aurora, Colorado, United States
• Research Site, Bethesda, Maryland, United States
• Research Site, Ann Arbor, Michigan, United States
• Research Site, Northfield, New Jersey, United States
• Research Site, The Bronx, New York, United States
• Research Site, Durham, North Carolina, United States
• Research Site, Cleveland, Ohio, United States
• Research Site, Salt Lake City, Utah, United States
• Research Site, Buenos Aires, Argentina
• Research Site, Florida, Argentina
• Research Site, Lobos, Argentina
• Research Site, Mar del Plata, Argentina

+ 33 more sites.

Who to contact

AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07444567.