AsthmaPhase 3ROSY-FNCT07444567
Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
A Phase 3 study testing Benralizumab in people with Asthma and Eosinophilic Granulomatosis With Polyangiitis (EGPA), run by AstraZeneca at 46 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Asthma, Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilic Syndrome (HES)
- What is being tested?
- Benralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 46 sitesin 14 countries
- Study dates
- 24 Jul 2026to 27 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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).
- 6. Participants who discontinued the parent study prior to completing the minimum OLE or treatment period.
- 7. Local access to commercially available benralizumab.
Trial locations and contacts
46 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
46 sites in 14 countries
Argentina9 sites, 9 recruiting
- Not yet recruiting
Research Site
Buenos Aires, C1121ABE
- Not yet recruiting
Research Site
Florida, B1602DQD
- Not yet recruiting
Research Site
Lobos, 7240
- Recruiting
Research Site
Mar del Plata, B7600FYK
- Not yet recruiting
Research Site
Mendoza, 5500
- Not yet recruiting
Research Site
Mendoza, M5500
- Not yet recruiting
Research Site
Rosario, 2000
- Recruiting
Research Site
Rosario, 2000
- Not yet recruiting
Research Site
San Juan Bautista, 1888
United States8 sites, 8 recruiting
- Not yet recruiting
Research Site
Ann Arbor, Michigan, 48105
- Not yet recruiting
Research Site
Aurora, Colorado, 80045
- Not yet recruiting
Research Site
Bethesda, Maryland, 20892
- Not yet recruiting
Research Site
Cleveland, Ohio, 44106
- Not yet recruiting
Research Site
Durham, North Carolina, 27705
- Not yet recruiting
Research Site
Northfield, New Jersey, 08225
- Not yet recruiting
Research Site
Salt Lake City, Utah, 84107
- Not yet recruiting
Research Site
The Bronx, New York, 10459
France8 sites, 8 recruiting
- Not yet recruiting
Research Site
Bron, 69677
- Not yet recruiting
Research Site
Marseille, 13915
- Not yet recruiting
Research Site
Montpellier, 34090
- Not yet recruiting
Research Site
Nantes, 44093
- Not yet recruiting
Research Site
Paris, 75014
- Not yet recruiting
Research Site
Paris, 75018
- Not yet recruiting
Research Site
Pessac, 33604
- Not yet recruiting
Research Site
Suresnes, 92151
Canada5 sites, 5 recruiting
- Not yet recruiting
Research Site
Calgary, British Columbia, T2N 4N1
- Not yet recruiting
Research Site
Hamilton, Ontario, L8N 4A6
- Recruiting
Research Site
Toronto, Ontario, M5G 1E2
- Not yet recruiting
Research Site
Toronto, Ontario, M5G 1X8
- Recruiting
Research Site
Toronto, Ontario, M5T 3A9
Poland4 sites, 3 recruiting
- Not yet recruiting
Research Site
Chęciny, 26-060
- Not yet recruiting
Research Site
Gdansk, 80-214
- Not yet recruiting
Research Site
Lodz, 90-153
- Withdrawn
Research Site
Lodz, 90-302
Belgium2 sites, 2 recruiting
- Not yet recruiting
Research Site
Brussels, 1070
- Not yet recruiting
Research Site
Edegem, B-2650
India2 sites, 1 recruiting
- Withdrawn
Research Site
Ahmedabad, 380052
- Not yet recruiting
Research Site
Ajmer, 305001
Israel2 sites, 2 recruiting
- Recruiting
Research Site
Haifa, 34362
- Not yet recruiting
Research Site
Holon, 5822012
Netherlands1 site, 1 recruiting
- Not yet recruiting
Research Site
Rotterdam, 3015 GD
Turkey (Türkiye)1 site, 1 recruiting
- Not yet recruiting
Research Site
Istanbul, 34093
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Research Site
London, W2 1NY
About this study
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
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.
Read the detailed description
This will be an open-label, non-randomised, multicentre, international study for eligible participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment as judged by the Investigator. Any clinical study conducted with benralizumab (Fasenra) for indications such as asthma, EGPA, HES and future indications from additional parent studies, is potentially a parent study.
Each participant continuing to receive clinical benefit from benralizumab but with no access to the drug after exiting the parent study must be seen at the Investigator site, offered the opportunity to transition to the ROSY-F. The duration of clinical benefit from study treatment for an individual participant can exceed the duration of a clinical trial. To ensure continued supply of treatment to a participant who, as judged by the Investigator, is still receiving benefit when he/she either completes or exits the parent study or when the parent study closes, a roll-over study is the most universally acceptable mechanism for continuing to provide ongoing study treatment.
- Conditions
- Asthma, Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilic Syndrome (HES)
- Being tested
- Benralizumab
- Keywords
- Asthma, Eosinophilic Granulomatosis with Polyangiitis (EGPA), Hypereosinophilic Syndrome (HES)
- Medical subject headings
- Asthma, Churg-Strauss Syndrome, Hypereosinophilic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabDrug
Also called Fasenra
Accessorized Pre-Filled Syringe (Solution for injection).
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab arm | Experimental | Benralizumab will be administrated as an subcutaneous injection at a frequency in line with that received in the parent study. Receives: Drug: Benralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be evaluated by monitoring and assessing SAEs and non-serious AEs reported throughout the study and until 8 weeks after the last dose of benralizumab
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
Measured: From baseline until 8 weeks after the last dose of benralizumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start24 Jul 2026
- Primary completion27 Dec 2029 (estimated)
- Study completion27 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444567
- Sponsor's protocol ID
- D3250N00036
- Acronym
- ROSY-F
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07444567
- Acronym / sponsor ID
- ROSY-F / D3250N00036
- Conditions
- Asthma, Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilic Syndrome (HES)
- Keywords
- Asthma, Eosinophilic Granulomatosis with Polyangiitis (EGPA), Hypereosinophilic Syndrome (HES)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- 27 Dec 2029 (estimated)
- Study completion
- 27 Dec 2029 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be an open-label, non-randomised, multicentre, international study for eligible participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment as judged by the Investigator. Any clinical study conducted with benralizumab (Fasenra) for indications such as asthma, EGPA, HES and future indications from additional parent studies, is potentially a parent study.
Each participant continuing to receive clinical benefit from benralizumab but with no access to the drug after exiting the parent study must be seen at the Investigator site, offered the opportunity to transition to the ROSY-F. The duration of clinical benefit from study treatment for an individual participant can exceed the duration of a clinical trial. To ensure continued supply of treatment to a participant who, as judged by the Investigator, is still receiving benefit when he/she either completes or exits the parent study or when the parent study closes, a roll-over study is the most universally acceptable mechanism for continuing to provide ongoing study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benralizumab arm | Experimental | Drug: BenralizumabBenralizumab will be administrated as an subcutaneous injection at a frequency in line with that received in the parent study. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenralizumabAlso: FasenraAccessorized Pre-Filled Syringe (Solution for injection). | Drug | Benralizumab arm |
Primary outcome
Safety will be evaluated by monitoring and assessing SAEs and non-serious AEs reported throughout the study and until 8 weeks after the last dose of benralizumab
Time frame: From baseline until 8 weeks after the last dose of benralizumab
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
46 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benralizumab in people with Asthma and Eosinophilic Granulomatosis With Polyangiitis (EGPA), run by AstraZeneca at 46 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Argentina, United States, France, Canada, Poland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety will be evaluated by monitoring and assessing SAEs and non-serious AEs reported throughout the study and until 8 weeks after the last dose of benralizumab (time frame: From baseline until 8 weeks after the last dose of benralizumab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.