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NCT07444567PHASE3Recruiting

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

AstraZeneca

Start Date

7/24/2026

Completion Date

12/27/2029

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.

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.

Eligibility Criteria

Age Range: 6 years to No maximum

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.

Interventions

DRUG

Benralizumab

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Conditions

AsthmaEosinophilic Granulomatosis With Polyangiitis (EGPA)Hypereosinophilic Syndrome (HES)

Locations

Research Site

Aurora, Colorado 80045

United States

Research Site

Bethesda, Maryland 20892

United States

Research Site

Ann Arbor, Michigan 48105

United States

Research Site

Northfield, New Jersey 08225

United States

Research Site

The Bronx, New York 10459

United States

Research Site

Durham, North Carolina 27705

United States

Research Site

Cleveland, Ohio 44106

United States

Research Site

Salt Lake City, Utah 84107

United States

Research Site

Buenos Aires, C1121ABE

Argentina

Research Site

Florida, B1602DQD

Argentina

Research Site

Lobos, 7240

Argentina

Research Site

Mar del Plata, B7600FYK

Argentina

Research Site

Mendoza, 5500

Argentina

Research Site

Mendoza, M5500

Argentina

Research Site

Rosario, 2000

Argentina

Research Site

Rosario, 2000

Argentina

Research Site

San Juan Bautista, 1888

Argentina

Research Site

Innsbruck, 6020

Austria

Research Site

Brussels, 1070

Belgium

Research Site

Edegem, B-2650

Belgium

Research Site

Calgary, British Columbia T2N 4N1

Canada

Research Site

Hamilton, Ontario L8N 4A6

Canada

Research Site

Toronto, Ontario M5G 1E2

Canada

Research Site

Toronto, Ontario M5G 1X8

Canada

Research Site

Toronto, Ontario M5T 3A9

Canada

Research Site

Bron, 69677

France

Research Site

Marseille, 13915

France

Research Site

Montpellier, 34090

France

Research Site

Nantes, 44093

France

Research Site

Paris, 75014

France

Research Site

Paris, 75018

France

Research Site

Pessac, 33604

France

Research Site

Suresnes, 92151

France

Research Site

Ahmedabad, 380052

India

Research Site

Ajmer, 305001

India

Research Site

Haifa, 34362

Israel

Research Site

Holon, 5822012

Israel

Research Site

Roma, 00165

Italy

Research Site

Rotterdam, 3015 GD

Netherlands

Research Site

Chęciny, 26-060

Poland

Research Site

Gdansk, 80-214

Poland

Research Site

Lodz, 90-153

Poland

Research Site

Lodz, 90-302

Poland

Research Site

Incheon, 400-711

South Korea

Research Site

Istanbul, 34093

Turkey (Türkiye)

Research Site

London, W2 1NY

United Kingdom