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Taking peoplePhase 3

Continued benralizumab treatment for people with asthma, EGPA or hypereosinophilic syndrome

Lets people finishing an earlier benralizumab study keep taking it while safety is monitored.

Key facts

Who runs it
AstraZeneca
Where
Roma, ItalySee the siteAlso in 13 other countries, 40 sites
Trial code
Registry title
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
230 people, planned
Started
24 Jul 2026
Expected to end
27 Dec 2029
Type of study
Interventional
Treatments tested
  • Benralizumab
Record updated
10 November 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 that they benefit from continuing the treatment. They must not be able to get benralizumab through normal local access.

Age
6 years and older
Sex
All sexes can join
Disease stage
People with asthma, eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome (HES) who finished the minimum open-label extension period of a parent study.
Earlier treatment
Must have completed the minimum required open-label extension period of a previous (parent) study with benralizumab. Must not plan live or live-attenuated vaccines or biologic therapies (with a narrow exception when no alternative medicine exists for another condition).

Main reasons for not taking part

  • Ongoing unresolved side effect that stopped treatment at the end of the parent study and would prevent restarting benralizumab
  • Planning to use live or live-attenuated vaccines
  • Planning to use biologic therapies, except for other conditions when no alternative medicine is available
  • Taking part in another clinical study at the same time (other than the parent study)
  • Stopped the parent study before finishing the minimum treatment period, or has local access to commercially available benralizumab

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 1. 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
  • 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

Who cannot take part

  • 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
  • 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
  • 5. Concurrently enrolled in any clinical study (other than a parent study)
  • 7. Local access to commercially available benralizumab

Where in Italy

Also in 13 other countries, 40 sites

  • RomaHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • Benralizumab armTreatment being tested

    Benralizumab will be administrated as an subcutaneous injection at a frequency in line with that received in the parent study.

    Treatment: 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 → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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 treatment for people with asthma, EGPA or hypereosinophilic syndromeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 11 November 2026.
Record updated
10 November 2026