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New drug could simplify treatment for rare EGPA disease

NCT ID NCT04157348

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This study tests whether a newer drug, benralizumab, works as well as the current standard, mepolizumab, for people with a rare disease called EGPA that inflames blood vessels. About 140 adults with active EGPA will receive either drug for a year, along with their usual steroids. The goal is to see if benralizumab can help more patients achieve remission with fewer steroid side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Benralizumab (a biologic drug given as an injection)
What this could lead to
If benralizumab works as well or better than mepolizumab, it could offer a new treatment option for EGPA, potentially with fewer injections.
What could go wrong
This is a Phase 3 trial, but results are not yet final. Benralizumab may not prove superior or may have unexpected side effects. The study is also relatively small (140 participants).

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

140 people

The number who actually took part.

Started

Oct 2019

Expected to finish

Nov 2026

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

18 to 130 years

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. Male or female subjects age 18 years or older. 2. EGPA diagnosis based on history or presence asthma and eosinophilia (\>1.0x10\^9/L and/or \>10% of leucocytes) and at least 2 of; biopsy with eosinophilic vasculitis or perivascular/granulomatous inflammation; mono-or polyneuropathy, non-fixed pulmonary infiltrates, sino-nasal abnormality; cardiomyopathy; glomerulonephritis; alveolar haemorrhage; palpable purpura; anti neutrophil cytoplasmic anti-body (ANCA) positivity (Myeloperoxidase or proteinease 3). 3. History of relapsing (at least 1 confirmed EGPA relapse within last 2 years and \> 12 weeks prior to screening), or refractory (failure to attain remission, defined as BVAS=0 and oral corticosteroid (OCS) dose \<=7.5 mg/day of prednisolone or equivalent, following standard induction regimen for at least 3 months and within 6 months prior to screening, or recurrence of symptoms upon OCS tapering at any dose of ≥7.5 mg/day prednisolone or equivalent. If induction with glucocorticoidsalone, patient must have failed to attain remission after 3 months and the glucocorticoid dose must be ≥15 mg/day prednisolone or equivalent for the 4 weeks prior to randomization. 4. Must be on a stable dose of oral prednisolone or prednisone of ≥7.5 mg/day (but not \>50mg/day) for at least 4 weeks prior to randomization. 5. If receiving immunosuppressive therapy (excluding cyclophosphamide) the dose must be stable for the 4 weeks prior to randomization and during the study (dose reductions for safety reasons will be permitted). 6. QTc(F)\<450 msec or QTc(F)\<480 msec for patients with bundle branch block. 7. Females of childbearing potential must use an acceptable method of birth control from randomization for at least 12 weeks after the last study drug administration. Exclusion Criteria: 1. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) 2. Organ or life-threatening EGPA \< 3 months prior to screening 3. Currently pregnant or breastfeeding, or planning to become pregnant during study participation. 4. Current malignancy or history of malignancy, unless received curative therapy \>5 years ago, or \>1 year ago for basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix 5. An untreated or refractory helminth parasitic infection \< 24 weeks prior to screening 6. Unstable liver disease 7. Severe or clinically significant, uncontrolled cardiovascular disease 8. Other concurrent disease that may put the patient at risk, or may influence the results of the study, or the patients' ability to complete entire duration of the study 9. Chronic or ongoing infectious disease requiring systemic anti-infective treatment 10. Known immunodeficiency disorder or positive HIV test 11. Prior receipt of mepolizumab, reslizumab, dupilumab or benralizumab. Receipt of intravenous/intramuscular/subcutaneous corticosteroids within 4 weeks prior to randomization, receipt of omalizumab within 130 days prior to screening, rituximab within 6 months prior to screening (or B-cells not recovered), interferon-α or alemtuzumab within 6 months prior to screening, receipt of anti-tumor necrosis factor therapy within 12 weeks prior to screening or an investigational non-biologic product within 30 days or 5 half-lives prior to screening, whichever is longer. Receipt of any other marketed or investigational biologic products within 4 months or 5 half-lives prior to screening, whichever is longer.

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Conditions

The condition(s) this trial relates to.

eosinophilic granulomatosis with polyangiitis

As listed by the trial registrant

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

Eosinophilic granulomatous vasculitis

Contacts and locations

Locations

  • Research Site

    Denver, Colorado, 80206, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Rochester, Minnesota, 55905-0001, United States

  • Research Site

    Albuquerque, New Mexico, 87106, United States

  • Research Site

    Great Neck, New York, 11021, United States

  • Research Site

    New York, New York, 10021, United States

  • Research Site

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    Denison, Texas, 75020, United States

  • Research Site

    Seattle, Washington, 98115, United States

  • Research Site

    Brussels, 1070, Belgium

  • Research Site

    Brussels, 1090, Belgium

  • Research Site

    Calgary, Alberta, T2N 4Z6, Canada

  • Research Site

    Hamilton, Ontario, L8N 4A6, Canada

  • Research Site

    Toronto, Ontario, M5G 1E2, Canada

  • Research Site

    Toronto, Ontario, M5T 3A9, Canada

  • Research Site

    Dijon, 21079, France

  • Research Site

    Marseille, 13915, France

  • Research Site

    Montpellier, 34090, France

  • Research Site

    Nantes, 44093, France

  • Research Site

    Paris, 75014, France

  • Research Site

    Paris, 75877, France

  • Research Site

    Suresnes, 92151, France

  • Research Site

    Toulouse, 31059, France

  • Research Site

    Bamberg, 96049, Germany

  • Research Site

    Freiburg im Breisgau, 79106, Germany

  • Research Site

    Hamburg, 20251, Germany

  • Research Site

    Kirchheim, 73230, Germany

  • Research Site

    Lübeck, 23538, Germany

  • Research Site

    Ashkelon, 7830604, Israel

  • Research Site

    Beersheba, 84101, Israel

  • Research Site

    Jerusalem, 91120, Israel

  • Research Site

    Ramat Gan, 52621, Israel

  • Research Site

    Rehovot, 7661041, Israel

  • Research Site

    Tel Aviv, 6423906, Israel

  • Research Site

    Cuneo, 12100, Italy

  • Research Site

    Florence, 50141, Italy

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Milan, 20162, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Roma, 00168, Italy

  • Research Site

    Torino, 10128, Italy

  • Research Site

    Chiba, 260-0877, Japan

  • Research Site

    Kita-gun, 761-0793, Japan

  • Research Site

    Sagamihara-shi, 228-0815, Japan

  • Research Site

    Sendai, 980-8574, Japan

  • Research Site

    Shinjuku-ku, 162-8666, Japan

  • Research Site

    Cambridge, CB2 0QQ, United Kingdom

  • Research Site

    Leicester, LE3 9QP, United Kingdom

  • Research Site

    London, SE19RT, United Kingdom

  • Research Site

    Portsmouth, PO6 3LY, United Kingdom