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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

Next steps

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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (17)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet InnsbruckInnsbruckAustriaNot yet recruiting
Hopital ErasmeAnderlechtBelgiumRecruiting
Universitair Ziekenhuis AntwerpenEdegemBelgiumRecruiting
RigshospitaletCopenhagen OeDenmarkWithdrawn
Hospices Civils de LyonBronFranceRecruiting
Centre Hospitalier Regional De MarseilleMarseilleFranceRecruiting
Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5FranceRecruiting
Centre Hospitalier Universitaire de NantesNantesFranceRecruiting
Assistance Publique Hopitaux de ParisParisFranceRecruiting
Assistance Publique Hopitaux De ParisParis Cedex 18FranceRecruiting
Centre Hospitalier Universitaire de BordeauxPessacFranceRecruiting
Hospital FochSuresnesFranceRecruiting
Ospedale Pediatrico Bambino GesùRomeItalyNot yet recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)RotterdamNetherlandsNot yet recruiting
Wojewodzki Szpital Specjalistyczny Im. Sw. Rafala W Czerwonej GorzeChecinyPolandNot yet recruiting
Uniwersyteckie Centrum KliniczneGdanskPolandNot yet recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W LodziLodzPolandNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.