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New drug aims to tame rare inflammatory disease

NCT ID NCT05263934

Disease control Sponsor: GlaxoSmithKline 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether a new drug, depemokimab, works as well as the current treatment mepolizumab for adults with a rare disease called EGPA, which causes inflammation of blood vessels. The study involves 163 participants and aims to see if depemokimab can help patients achieve remission while reducing their steroid use. Results are expected after 52 weeks of treatment.

What this could mean

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

Active substance
depemokimab (compared to mepolizumab)
What this could lead to
If depemokimab works as well as mepolizumab, it could offer a new treatment option for EGPA, potentially with less frequent dosing.
What could go wrong
This is a non-inferiority trial, so depemokimab may not be better than the existing drug. Results are still pending, and individual responses may vary.

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

163 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Oct 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 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: * Participant (male or female) must be 18 years of age or older at the time of signing the informed consent. * Participants who are \>=40 kilogram at Screening Visit 1. * Participants with a documented diagnosis of EGPA for at least 6 months based on the history or presence of: asthma plus eosinophilia defined as \>1.0\*10\^9/Liter (L) and/or \>10 percentage (%) of leucocytes plus at least 2 of the following additional features of EGPA: a biopsy showing histopathological evidence of eosinophilic vasculitis, or perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation, neuropathy, mono or poly (motor deficit or nerve conduction abnormality), pulmonary infiltrates, non-fixed, sino-nasal abnormality, cardiomyopathy (established by echocardiography or magnetic resonance imaging), glomerulonephritis (hematuria, red cell casts, proteinuria), alveolar hemorrhage (by bronchoalveolar lavage), palpable purpura, anti-neutrophil cytoplasmic antibodies positive Myeloperoxidase or Proteinase 3. * History of relapsing OR refractory disease. * Participants must be on a stable dose of oral prednisolone or prednisone of \>=7.5 mg/day (but not \>50 mg/day) or equivalent for at least 4 weeks prior to Baseline (Visit 2). * If participants receiving immunosuppressive therapy (excluding cyclophosphamide) the dosage must be stable for the 4 weeks prior to Baseline (Visit 2) and during the study. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of \<1%. * Capable of giving signed informed consent Exclusion Criteria: * Participants diagnosed with granulomatosis with polyangiitis; previously known as Wegener's granulomatosis or microscopic polyangiitis. * Participants with organ-threatening EGPA as per EULAR criteria, * Imminently life-threatening EGPA disease within 3 months prior to Screening (Visit 1). * A current malignancy or previous history of cancer in remission for less than 12 months prior to Screening. * Participants with alanine aminotransferase \>2\*upper limit of normal (ULN) or if participant is on background methotrexate or azathioprine \>3\*ULN, aspartate aminotransferase \>2\*ULN or if participant is on background methotrexate or azathioprine \>3\*ULN, alkaline phosphatase \>=2.0\*ULN, total bilirubin \>1.5\*ULN (isolated bilirubin \>1.5\*ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%), Cirrhosis or current unstable liver or biliary disease per investigator assessment. * Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment. * Participants who have known, pre-existing, clinically significant system abnormalities that are not associated with EGPA and are uncontrolled with standard treatment. * Clinically significant abnormality in the hematological, biochemical or urinalysis screen at Visit 1. * Chronic or ongoing active infectious disease requiring systemic treatment. * Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening Visit 1. * A known immunodeficiency (e.g., human immunodeficiency virus \[HIV\]). * Participants that, according to the investigator's medical judgment, are likely to have active coronavirus disease 2019 (COVID-19) infection. Participants with known COVID-19 positive contacts within the past 14 days must be excluded for at least 14 days following the exposure during which the participant must remain symptom-free. * Participants with a known allergy or intolerance to a monoclonal antibody or biologic therapy or any of the excipients of the investigational products. * Participants who have a previous documented failure with anti-Interleukin-5 /Interleukin-5 receptor therapy (e.g., mepolizumab, reslizumab, benralizumab). Participants who have received monoclonal antibodies (mAb) and who have not undergone the required washout periods, prior to Visit 1. * Participants receiving any of the following: Oral corticosteroids: Participant requires an oral corticosteroid dose of \>50 mg/day prednisolone/prednisone in the 4-week period prior to Baseline (Visit 2), Intravenous (IV), intramuscular or subcutaneous (SC) corticosteroids in the 4-week period prior to Baseline (Visit 2), Omalizumab within 130 days prior to Screening (Visit 1), Cyclophosphamide (CYC): oral CYC within 4 weeks prior to Baseline (Visit 2) and IV CYC within 3 weeks prior to Baseline (Visit 2), if their total white blood cells is \>=4\*10\^9/L (measured using the local laboratory if necessary), Rituximab within 12 months prior to Screening (Visit 1); in addition, the Participant must have shown recovery of peripheral B-cell count to within the normal range, Tezepelumab and Dupilumab with a washout period of 5 half-lives prior to Screening Visit 1, IV or SC immunoglobulin within 6 months prior to Screening (Visit 1); For China and Japan only within 12 weeks prior to Screening (Visit 1), Interferon-alpha within 6 months prior to Screening Visit 1, Anti-tumor necrosis factor therapy within 12 weeks prior to Screening Visit 1, Anti-CD52 (alemtuzumab) within 6 months prior to Screening Visit 1. * Participants with QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>=450 milliseconds (msec) or QTcF \>=480 msec for participants with Bundle Branch Block in the 12-lead ECG central over-read from at Screening Visit 1.

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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 granulomatosis with polyangiitis

Contacts and locations

Locations

  • GSK Investigational Site

    Denver, Colorado, 80206, United States

  • GSK Investigational Site

    Gainesville, Florida, 32610, United States

  • GSK Investigational Site

    Rochester, Minnesota, 55905, United States

  • GSK Investigational Site

    New York, New York, 10021, United States

  • GSK Investigational Site

    Charlotte, North Carolina, 28211, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15261, United States

  • GSK Investigational Site

    La Plata, B1900, Argentina

  • GSK Investigational Site

    San Miguel de Tucumán, T4000, Argentina

  • GSK Investigational Site

    Graz, 8036, Austria

  • GSK Investigational Site

    Santo André, 09060-870, Brazil

  • GSK Investigational Site

    São Paulo, 4023900, Brazil

  • GSK Investigational Site

    Toronto, Ontario, M5T 3A9, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5T 3L9, Canada

  • GSK Investigational Site

    Beijing, 100005, China

  • GSK Investigational Site

    Guangzhou, 510163, China

  • GSK Investigational Site

    Hefei, 230001, China

  • GSK Investigational Site

    Nanjing, 210006, China

  • GSK Investigational Site

    Qingdao, 266071, China

  • GSK Investigational Site

    Shanghai, 200032, China

  • GSK Investigational Site

    Shenzhen, 518020, China

  • GSK Investigational Site

    Wenzhou, 325000, China

  • GSK Investigational Site

    La Roche-sur-Yon, 85925, France

  • GSK Investigational Site

    Nantes, 44093, France

  • GSK Investigational Site

    Paris, 75014, France

  • GSK Investigational Site

    Freiburg im Breisgau, 79106, Germany

  • GSK Investigational Site

    Minden, 32429, Germany

  • GSK Investigational Site

    Ramat Gan, 52621, Israel

  • GSK Investigational Site

    Bari, 70124, Italy

  • GSK Investigational Site

    Brescia, 25123, Italy

  • GSK Investigational Site

    Florence, 50134, Italy

  • GSK Investigational Site

    Milan, 20132, Italy

  • GSK Investigational Site

    Milan, 20162, Italy

  • GSK Investigational Site

    Pavia, 27100, Italy

  • GSK Investigational Site

    Pisa, 56126, Italy

  • GSK Investigational Site

    Roma, 00128, Italy

  • GSK Investigational Site

    Torrette AN, 60126, Italy

  • GSK Investigational Site

    Treviso, 31100, Italy

  • GSK Investigational Site

    Kanagawa, 247-8533, Japan

  • GSK Investigational Site

    Kanagawa, 252-0392, Japan

  • GSK Investigational Site

    Saitama, 350-8550, Japan

  • GSK Investigational Site

    Tokyo, 162-8666, Japan

  • GSK Investigational Site

    Tokyo, 181-8611, Japan

  • GSK Investigational Site

    Groningen, 9713 GZ, Netherlands

  • GSK Investigational Site

    Leiden, 2333 ZA, Netherlands

  • GSK Investigational Site

    Gdansk, 80-952, Poland

  • GSK Investigational Site

    Lodz, 90-153, Poland

  • GSK Investigational Site

    Warsaw, 01-138, Poland

  • GSK Investigational Site

    Lisbon, 1649-035, Portugal

  • GSK Investigational Site

    Porto, 4099-001, Portugal

  • GSK Investigational Site

    Gwangju, 61469, South Korea

  • GSK Investigational Site

    Seoul, 05505, South Korea

  • GSK Investigational Site

    Seoul, 06351, South Korea

  • GSK Investigational Site

    Seoul, 06591, South Korea

  • GSK Investigational Site

    Seoul, 3080, South Korea

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Granada, 18014, Spain

  • GSK Investigational Site

    Pamplona, 31008, Spain

  • GSK Investigational Site

    Zaragoza, 50009, Spain

  • GSK Investigational Site

    Malmö, SE-205 02, Sweden

  • GSK Investigational Site

    Birmingham, B15 2GW, United Kingdom

  • GSK Investigational Site

    Cambridge, CB2 2QQ, United Kingdom

  • GSK Investigational Site

    London, SE1 7EH, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.