NCT07444567 · AstraZeneca
Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
(ROSY-F)
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 how well patients handle the treatment of benralizumab.
View original scientific description
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.
Interventions
DRUG
Benralizumab
Accessorized Pre-Filled Syringe (Solution for injection).
Primary outcome 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
Time frame: From baseline until 8 weeks after the last dose of benralizumab
To provide benralizumab to participants who continue to benefit at the end of the parent clinical study while monitoring long-term safety and tolerability of benralizumab
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Aurora, Colorado
- Bethesda, Maryland
- Ann Arbor, Michigan
- Northfield, New Jersey
- The Bronx, New York
- Durham, North Carolina
- Cleveland, Ohio
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2026 · Source of record for eligibility and locations