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

NCT07444567 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: D3250N00036
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  From baseline until 8 weeks after the last dose of benralizumab

Study Arms (1)

Benralizumab arm

EXPERIMENTAL

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

Drug: Benralizumab

Interventions

Benralizumab DRUG

Accessorized Pre-Filled Syringe (Solution for injection).

Also known as: Fasenra

Benralizumab arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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 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.

You may not qualify if:

• \. 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 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).
• \. Participants who discontinued the parent study prior to completing the minimum OLE or treatment period.
• \. Local access to commercially available benralizumab.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Asthma; Churg-Strauss Syndrome; Hypereosinophilic Syndrome

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Eosinophilia; Leukocyte Disorders; Hematologic Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: March 3, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): December 28, 2029
• Study Completion (Estimated): December 28, 2029
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.