NCT07444567RecruitingPhase 3
Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- First submitted
- 17 Feb 2026
- Start date
- 24 Jul 2026
- Primary completion date
- 27 Dec 2029
- Lead sponsor
- AstraZeneca
- Diseases
- Asthma, ANCA-associated vasculitis
- NCT number
- NCT07444567
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 230
- From 24 Jul 2026 to the primary completion date, 27 Dec 2029
- 41 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 6\. Participants who discontinued the parent study prior to completing the minimum OLE or treatment period.
Other illness
- 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.
Other
- 5\. Concurrently enrolled in any clinical study (other than a parent study).
- 7\. Local access to commercially available benralizumab.
Who the study is looking for
- 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.
Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Florida | Argentina | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Lobos | Argentina | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Mendoza | Argentina | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Rosario | Argentina | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | San Juan Bautista | Argentina | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Innsbruck | Austria | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Edegem | Belgium | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Calgary | Canada | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Hamilton | Canada | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Bron | France | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Suresnes | France | Recruiting |
| Research Site Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Holon | Israel | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Petah Tikva | Israel | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Ahmedabad | India | Withdrawn |
| Research Site Coordinator of this site? Confirm its status | Ajmer | India | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Roma | Italy | Withdrawn |
| Research Site Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Chęciny | Poland | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Gdansk | Poland | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Lodz | Poland | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Ann Arbor | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Aurora | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Bethesda | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Cleveland | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Durham | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Northfield | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Salt Lake City | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | The Bronx | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.