Under construction – not a live service
Sign in
Taking peoplePhase 3

Continued benralizumab for people with EGPA, HES or asthma who finished an earlier study

Gives benralizumab to people still helped by it after an earlier study.

Key facts

Who runs it
AstraZeneca AB
Where
Copenhagen Oe, DenmarkSee the siteAlso in 6 other countries, 16 sites
Registry title
ROSY-F: Roll-over Study for Participants Who Have Completed a Previous Clinical Study with Benralizumab (Fasenra) and Benefit from Continued Treatment
Status
Recruiting
Phase
Phase 3
People taking part
94 people, planned
Started
21 Sept 2026
Expected to end
31 Dec 2029
Type of study
Interventional
Record updated
3 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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)
  • Local access to commercially available benralizumab

Where in Denmark

Also in 6 other countries, 16 sites

  • RigshospitaletCopenhagen Oe, DenmarkNo longer taking part

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
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
Plain-language title
Continued benralizumab for people with EGPA, HES or asthma who finished an earlier studyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
3 September 2026