What this study is
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.
What's being tested
- Benralizumab
Intervention · DRUG
Accessorized Pre-Filled Syringe (Solution for injection).
Study details
- Official title
- 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
- Sponsor
- AstraZeneca
- Conditions
- Asthma · Eosinophilic Granulomatosis With Polyangiitis (EGPA) · Hypereosinophilic Syndrome (HES)
- Enrolling
- 230 people
- Starts
- 2026-07-24
- Est. completion
- 2029-12-27
- Design
- Open-label, non-randomized, single group, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Years and overSex ALLHealthy volunteers Not acceptedYou 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 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 can't 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (47)
44 openResearch Site
Aurora, Colorado, United States
Not yet recruitingResearch Site
Bethesda, Maryland, United States
Not yet recruitingResearch Site
Ann Arbor, Michigan, United States
Not yet recruitingResearch Site
Northfield, New Jersey, United States
Not yet recruitingResearch Site
The Bronx, New York, United States
Not yet recruitingResearch Site
Durham, North Carolina, United States
Not yet recruitingResearch Site
Cleveland, Ohio, United States
Not yet recruitingResearch Site
Salt Lake City, Utah, United States
Not yet recruiting
39 sites outside the US
Research Site
Buenos Aires, Argentina
RecruitingResearch Site
Florida, Argentina
RecruitingResearch Site
Lobos, Argentina
Not yet recruitingResearch Site
Mar del Plata, Argentina
RecruitingResearch Site
Mendoza, Argentina
RecruitingResearch Site
Mendoza, Argentina
RecruitingResearch Site
Rosario, Argentina
Not yet recruitingResearch Site
Rosario, Argentina
RecruitingResearch Site
San Juan Bautista, Argentina
Not yet recruitingResearch Site
Innsbruck, Austria
Not yet recruitingResearch Site
Brussels, Belgium
RecruitingResearch Site
Edegem, Belgium
Not yet recruitingResearch Site
Calgary, Alberta, Canada
Not yet recruitingResearch Site
Hamilton, Ontario, Canada
Not yet recruitingResearch Site
Toronto, Ontario, Canada
RecruitingResearch Site
Toronto, Ontario, Canada
Not yet recruitingResearch Site
Toronto, Ontario, Canada
RecruitingResearch Site
Bron, France
Not yet recruitingResearch Site
Marseille, France
RecruitingResearch Site
Montpellier, France
RecruitingResearch Site
Nantes, France
RecruitingResearch Site
Paris, France
RecruitingResearch Site
Paris, France
RecruitingResearch Site
Pessac, France
RecruitingResearch Site
Suresnes, France
RecruitingResearch Site
Ajmer, India
Not yet recruitingResearch Site
Haifa, Israel
RecruitingResearch Site
Holon, Israel
Not yet recruitingResearch Site
Petah Tikva, Israel
Not yet recruitingResearch Site
Rotterdam, Netherlands
Not yet recruitingResearch Site
Chęciny, Poland
Not yet recruitingResearch Site
Gdansk, Poland
Not yet recruitingResearch Site
Lodz, Poland
Not yet recruitingResearch Site
Incheon, South Korea
RecruitingResearch Site
Istanbul, Turkey (Türkiye)
Not yet recruitingResearch Site
London, United Kingdom
RecruitingResearch Site
Ahmedabad, India
WithdrawnResearch Site
Roma, Italy
WithdrawnResearch Site
Lodz, Poland
Withdrawn
Study team
Sponsor
AstraZeneca
Study ID D3250N00036
CONTACT
AstraZeneca Clinical Study Information Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.