Recruiting
Phase 3

Benralizumab

Sponsor:

AstraZeneca

Code:

NCT07444567

Conditions

Asthma

Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Hypereosinophilic Syndrome (HES)

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

Benralizumab

Study Details

Brief 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.

Conditions

Asthma

Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Hypereosinophilic Syndrome (HES)

Study ID

NCT07444567

Start date

Jul 24, 2026

Status verified date

Aug, 2026

Completion date

Jan 3, 2030

Anticipated

Primary completion date

Jan 3, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

230 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Benralizumab arm

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

Interventions

Benralizumab

Accessorized Pre-Filled Syringe (Solution for injection).

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 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Toronto, Ontario, Canada, M5G 1E2

More Information

Sponsor

AstraZeneca

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Asthma
  • Eosinophilic Granulomatosis with Polyangiitis (EGPA)
  • Hypereosinophilic Syndrome (HES)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-19.