2025-523307-29-00RecruitingPhase 3
ROSY-F: 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: EU CTIS (euclinicaltrials.eu) · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 94 (estimated)
- First submitted
- 21 Apr 2026
- Start date
- 21 Sept 2026
- Lead sponsor
- AstraZeneca AB
- Diseases
- ANCA-associated vasculitis, Asthma
- EU CT number
- 2025-523307-29-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 94
- 17 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people who finished an earlier benralizumab (Fasenra) study and whose doctor judges they benefit from continuing the treatment.
- Sex
- All sexes can join.
- Earlier treatment
- People must have completed the minimum open-label extension period of an earlier benralizumab study. People who left that study early cannot join.
Main reasons for not taking part
- An unresolved side effect that stopped treatment and, in the doctor's view, prevents restarting benralizumab
- Planning to use live or live-attenuated vaccines
- Planning to use biologic therapies, with an exception where no alternative medicine exists
- A medical or psychiatric condition that, in the doctor's view, would prevent taking part
- Local access to commercially available benralizumab
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 who discontinued the parent study prior to completing the minimum OLE or treatment period.
Other illness
- 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
- Concurrently enrolled in any clinical study (other than a parent study).
- Local access to commercially available benralizumab.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck | Innsbruck | Austria | Not yet recruiting |
| Hopital Erasme | Anderlecht | Belgium | Recruiting |
| Universitair Ziekenhuis Antwerpen | Edegem | Belgium | Recruiting |
| Rigshospitalet | Copenhagen Oe | Denmark | Withdrawn |
| Hospices Civils de Lyon | Bron | France | Recruiting |
| Centre Hospitalier Regional De Marseille | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier | Montpellier Cedex 5 | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Recruiting |
| Assistance Publique Hopitaux de Paris | Paris | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Paris Cedex 18 | France | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux | Pessac | France | Recruiting |
| Hospital Foch | Suresnes | France | Recruiting |
| Ospedale Pediatrico Bambino Gesù | Rome | Italy | Not yet recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Not yet recruiting |
| Wojewodzki Szpital Specjalistyczny Im. Sw. Rafala W Czerwonej Gorze | Checiny | Poland | Not yet recruiting |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Not yet recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi | Lodz | Poland | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.