Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
ROSY-F
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
1 other identifier
interventional
230
14 countries
46
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Jul 2026
Longer than P75 for phase_3 asthma
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2026
CompletedFirst Posted
Study publicly available on registry
March 3, 2026
CompletedStudy Start
First participant enrolled
July 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 27, 2029
September 22, 2026
September 1, 2026
3.4 years
February 17, 2026
September 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
From baseline until 8 weeks after the last dose of benralizumab
Study Arms (1)
Benralizumab arm
EXPERIMENTALBenralizumab will be administrated as an subcutaneous injection at a frequency in line with that received in the parent study.
Interventions
Accessorized Pre-Filled Syringe (Solution for injection).
Eligibility Criteria
You may qualify 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 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 qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (46)
Research Site
Aurora, Colorado, 80045, United States
Research Site
Bethesda, Maryland, 20892, United States
Research Site
Ann Arbor, Michigan, 48105, United States
Research Site
Northfield, New Jersey, 08225, United States
Research Site
The Bronx, New York, 10459, United States
Research Site
Durham, North Carolina, 27705, United States
Research Site
Cleveland, Ohio, 44106, United States
Research Site
Salt Lake City, Utah, 84107, United States
Research Site
Buenos Aires, C1121ABE, Argentina
Research Site
Florida, B1602DQD, Argentina
Research Site
Lobos, 7240, Argentina
Research Site
Mar del Plata, B7600FYK, Argentina
Research Site
Mendoza, 5500, Argentina
Research Site
Mendoza, M5500, Argentina
Research Site
Rosario, 2000, Argentina
Research Site
Rosario, 2000, Argentina
Research Site
San Juan Bautista, 1888, Argentina
Research Site
Innsbruck, 6020, Austria
Research Site
Brussels, 1070, Belgium
Research Site
Edegem, B-2650, Belgium
Research Site
Calgary, British Columbia, T2N 4N1, Canada
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Hamilton, Ontario, L8N 4A6, Canada
Research Site
Toronto, Ontario, M5G 1E2, Canada
Research Site
Toronto, Ontario, M5G 1X8, Canada
Research Site
Toronto, Ontario, M5T 3A9, Canada
Research Site
Bron, 69677, France
Research Site
Marseille, 13915, France
Research Site
Montpellier, 34090, France
Research Site
Nantes, 44093, France
Research Site
Paris, 75014, France
Research Site
Paris, 75018, France
Research Site
Pessac, 33604, France
Research Site
Suresnes, 92151, France
Research Site
Ahmedabad, 380052, India
Research Site
Ajmer, 305001, India
Research Site
Haifa, 34362, Israel
Research Site
Holon, 5822012, Israel
Research Site
Roma, 00165, Italy
Research Site
Rotterdam, 3015 GD, Netherlands
Research Site
Chęciny, 26-060, Poland
Research Site
Gdansk, 80-214, Poland
Research Site
Lodz, 90-153, Poland
Research Site
Lodz, 90-302, Poland
Research Site
Incheon, 400-711, South Korea
Research Site
Istanbul, 34093, Turkey (Türkiye)
Research Site
London, W2 1NY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2026
First Posted
March 3, 2026
Study Start
July 24, 2026
Primary Completion (Estimated)
December 27, 2029
Study Completion (Estimated)
December 27, 2029
Last Updated
September 22, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.