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Roll-Over study offers continued benralizumab access for patients who benefit

NCT ID NCT07444567

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study gives ongoing access to benralizumab (Fasenra) for people with asthma, eosinophilic granulomatosis with polyangiitis (EGPA), or hypereosinophilic syndrome (HES) who completed a prior benralizumab trial and still benefit from the drug. About 230 participants will receive continued treatment while researchers monitor long-term safety and side effects. The goal is to keep providing a working therapy and gather more safety data over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

asthma eosinophilic granulomatosis with polyangiitis hypereosinophilic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma Eosinophilic granulomatosis with polyangiitis (EGPA) Hypereosinophilic syndrome (HES)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    43 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    NOT_YET_RECRUITING

    Aurora, Colorado, 80045, United States

  • Research Site

    NOT_YET_RECRUITING

    Bethesda, Maryland, 20892, United States

  • Research Site

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48105, United States

  • Research Site

    NOT_YET_RECRUITING

    Northfield, New Jersey, 08225, United States

  • Research Site

    NOT_YET_RECRUITING

    The Bronx, New York, 10459, United States

  • Research Site

    NOT_YET_RECRUITING

    Durham, North Carolina, 27705, United States

  • Research Site

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44106, United States

  • Research Site

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84107, United States

  • Research Site

    NOT_YET_RECRUITING

    Buenos Aires, C1121ABE, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Florida, B1602DQD, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Lobos, 7240, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Mar del Plata, B7600FYK, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Mendoza, 5500, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Mendoza, M5500, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Rosario, 2000, Argentina

  • Research Site

    NOT_YET_RECRUITING

    San Juan Bautista, 1888, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Innsbruck, 6020, Austria

  • Research Site

    NOT_YET_RECRUITING

    Brussels, 1070, Belgium

  • Research Site

    NOT_YET_RECRUITING

    Edegem, B-2650, Belgium

  • Research Site

    NOT_YET_RECRUITING

    Calgary, British Columbia, T2N 4N1, Canada

  • Research Site

    NOT_YET_RECRUITING

    Hamilton, Ontario, L8N 4A6, Canada

  • Research Site

    RECRUITING

    Toronto, Ontario, M5G 1E2, Canada

  • Research Site

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • Research Site

    NOT_YET_RECRUITING

    Toronto, Ontario, M5T 3A9, Canada

  • Research Site

    NOT_YET_RECRUITING

    Bron, 69677, France

  • Research Site

    NOT_YET_RECRUITING

    Marseille, 13915, France

  • Research Site

    NOT_YET_RECRUITING

    Montpellier, 34090, France

  • Research Site

    NOT_YET_RECRUITING

    Nantes, 44093, France

  • Research Site

    NOT_YET_RECRUITING

    Paris, 75014, France

  • Research Site

    NOT_YET_RECRUITING

    Paris, 75018, France

  • Research Site

    NOT_YET_RECRUITING

    Pessac, 33604, France

  • Research Site

    NOT_YET_RECRUITING

    Suresnes, 92151, France

  • Research Site

    WITHDRAWN

    Ahmedabad, 380052, India

  • Research Site

    NOT_YET_RECRUITING

    Ajmer, 305001, India

  • Research Site

    NOT_YET_RECRUITING

    Haifa, 34362, Israel

  • Research Site

    NOT_YET_RECRUITING

    Holon, 5822012, Israel

  • Research Site

    NOT_YET_RECRUITING

    Roma, 00165, Italy

  • Research Site

    NOT_YET_RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Research Site

    NOT_YET_RECRUITING

    Chęciny, 26-060, Poland

  • Research Site

    NOT_YET_RECRUITING

    Gdansk, 80-214, Poland

  • Research Site

    NOT_YET_RECRUITING

    Lodz, 90-153, Poland

  • Research Site

    WITHDRAWN

    Lodz, 90-302, Poland

  • Research Site

    NOT_YET_RECRUITING

    Incheon, 400-711, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Istanbul, 34093, Turkey (Türkiye)

  • Research Site

    NOT_YET_RECRUITING

    London, W2 1NY, United Kingdom

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