Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment

NCT07444567 — Phase 3, Recruiting, 230 participants, AstraZeneca

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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

RegistryNCT07444567, acronym ROSY-F
StatusRecruiting
PhasePhase 3
Study typeInterventional; non randomized, single group, masking: none, treatment
Enrollment230 (Estimated)
SponsorAstraZeneca (Industry)
ConditionsAsthma, Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilic Syndrome (HES)
InterventionsBenralizumab (Drug)
Datesstart 2026-07-24, primary completion 2029-12-27 (estimated), completion 2029-12-27 (estimated), first posted 2026-03-03, last updated 2026-09-22
Locations46 sites in United States, Argentina, Austria, Belgium, Canada, France, India, Israel and 6 more countries

Related Papers Related Patents Related Grants Related Experts
All trials for Asthma All trials for Eosinophilic Granulomatosis With Polyangiitis (EGPA) All trials of Benralizumab

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Benralizumab armExperimentalDrug: BenralizumabBenralizumab will be administrated as an subcutaneous injection at a frequency in line with that received in the parent study.
  • Benralizumab (Drug), also known as Fasenra: Accessorized Pre-Filled Syringe (Solution for injection).

+Outcome measures

Primary outcomes

  • 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 [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

+Eligibility

Sex: All, ages: 6 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Locations (46)

FacilityCityCountryStatus
Research SiteAurora, ColoradoUnited StatesNot yet recruiting
Research SiteBethesda, MarylandUnited StatesNot yet recruiting
Research SiteAnn Arbor, MichiganUnited StatesNot yet recruiting
Research SiteNorthfield, New JerseyUnited StatesNot yet recruiting
Research SiteThe Bronx, New YorkUnited StatesNot yet recruiting
Research SiteDurham, North CarolinaUnited StatesNot yet recruiting
Research SiteCleveland, OhioUnited StatesNot yet recruiting
Research SiteSalt Lake City, UtahUnited StatesNot yet recruiting
Research SiteBuenos AiresArgentinaNot yet recruiting
Research SiteFloridaArgentinaNot yet recruiting
Research SiteLobosArgentinaNot yet recruiting
Research SiteMar del PlataArgentinaRecruiting
Research SiteMendozaArgentinaNot yet recruiting
Research SiteMendozaArgentinaNot yet recruiting
Research SiteRosarioArgentinaNot yet recruiting
Research SiteRosarioArgentinaRecruiting
Research SiteSan Juan BautistaArgentinaNot yet recruiting
Research SiteInnsbruckAustriaNot yet recruiting
Research SiteBrusselsBelgiumNot yet recruiting
Research SiteEdegemBelgiumNot yet recruiting
Research SiteCalgary, British ColumbiaCanadaNot yet recruiting
Research SiteHamilton, OntarioCanadaNot yet recruiting
Research SiteToronto, OntarioCanadaRecruiting
Research SiteToronto, OntarioCanadaNot yet recruiting
Research SiteToronto, OntarioCanadaRecruiting
Research SiteBronFranceNot yet recruiting
Research SiteMarseilleFranceNot yet recruiting
Research SiteMontpellierFranceNot yet recruiting
Research SiteNantesFranceNot yet recruiting
Research SiteParisFranceNot yet recruiting
Research SiteParisFranceNot yet recruiting
Research SitePessacFranceNot yet recruiting
Research SiteSuresnesFranceNot yet recruiting
Research SiteAhmedabadIndiaWithdrawn
Research SiteAjmerIndiaNot yet recruiting
Research SiteHaifaIsraelRecruiting
Research SiteHolonIsraelNot yet recruiting
Research SiteRomaItalyWithdrawn
Research SiteRotterdamNetherlandsNot yet recruiting
Research SiteChęcinyPolandNot yet recruiting
Research SiteGdanskPolandNot yet recruiting
Research SiteLodzPolandNot yet recruiting
Research SiteLodzPolandWithdrawn
Research SiteIncheonSouth KoreaRecruiting
Research SiteIstanbulTurkey (Türkiye)Not yet recruiting
Research SiteLondonUnited KingdomNot yet recruiting