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Search / Trial NCT05263934

Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Launched by GLAXOSMITHKLINE · Feb 28, 2022

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Depemokimab Mepolizumab Eosinophilic Granulomatosis With Polyangiitis

ClinConnect Summary

This clinical trial is studying a new treatment called depemokimab to see how well it works compared to another treatment called mepolizumab for adults with a condition called Eosinophilic Granulomatosis With Polyangiitis (EGPA). EGPA is an autoimmune disease that can cause inflammation in different parts of the body, leading to symptoms like asthma and other serious health issues. The trial is currently recruiting participants aged 18 and older who have been diagnosed with EGPA for at least six months and have experienced relapses or ongoing symptoms despite treatment.

Participants in the study will receive either depemokimab or mepolizumab, along with their standard therapy. To join, individuals must meet specific health criteria, such as being stable on a certain dose of steroids and not having other serious health conditions that could complicate their participation. Throughout the trial, participants will be monitored for how well the treatment works and any side effects that may occur. This trial is important because it aims to find effective options for managing EGPA, particularly for those who have not responded well to existing treatments.

Gender

ALL

Eligibility criteria

  • 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) 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. 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.

About Glaxosmithkline

GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.

Locations

New York, New York, United States

Pavia, Lombardia, Italy

Lisboa, , Portugal

Barcelona, , Spain

Gainesville, Florida, United States

Groningen, , Netherlands

Porto, , Portugal

Norfolk, Virginia, United States

Leuven, , Belgium

Ramat Gan, , Israel

Tulsa, Oklahoma, United States

Rochester, Minnesota, United States

Charlotte, North Carolina, United States

Lille Cedex, , France

Freiburg, Baden Wuerttemberg, Germany

Bari, Puglia, Italy

Pisa, Toscana, Italy

Pamplona, , Spain

Philadelphia, Pennsylvania, United States

Manhasset, New York, United States

Nantes Cedex 1, , France

Treviso, Veneto, Italy

Leiden, , Netherlands

Zaragoza, , Spain

Denver, Colorado, United States

Suresnes, , France

Pittsburgh, Pennsylvania, United States

Bruxelles, , Belgium

Montpellier Cedex 5, , France

Kfar Saba, , Israel

Nashville, Tennessee, United States

Bari, , Italy

Malmö, , Sweden

Budapest, , Hungary

Granada, , Spain

Praha 8, , Czechia

Jeonju, , Korea, Republic Of

Paris, , France

Gdansk, , Poland

Toulouse Cedex 9, , France

Brescia, Lombardia, Italy

Warszawa, , Poland

Brest Cedex, , France

Toronto, Ontario, Canada

Firenze, , Italy

Milano, , Italy

Pessac, , France

London, , United Kingdom

Lodz, , Poland

Lille, , France

Toulouse, , France

Firenze, Toscana, Italy

Shanghai, , China

Milano, Lombardia, Italy

Angers Cedex 09, , France

Pavia, , Italy

Kanagawa, , Japan

Angers Cedex 9, , France

Nanjing, Jiangsu, China

Tokyo, , Japan

Roma, , Italy

Valencia, , Spain

Praha 4, , Czechia

Ramat Gan, , Israel

Seoul, , Korea, Republic Of

Shenyang, Liaoning, China

Graz, , Austria

Hefei, , China

Brescia, , Italy

Qingdao, Shandong, China

Chonju, , Korea, Republic Of

Pisa, , Italy

Leiden, Rc, , Netherlands

Cambridge, , United Kingdom

Roma, Lazio, Italy

Gwangju, , Korea, Republic Of

Minden, , Germany

Badalona, , Spain

Shenzhen, , China

Shen Zhen, Guangdong, China

Montpellier Cedex, , France

Saitama, , Japan

Guangzhou, , China

Wenzhou, , China

Guangzhou, , China

Praha, , Czechia

Badalona, , Spain

La Plata, Buenos Aires, Argentina

San Miguel De Tucuman, Tucumán, Argentina

Canberra, Australian Capital Territory, Australia

Santo André, São Paulo, Brazil

São Paulo, , Brazil

Kunming, Yunnan, China

Beijing, , China

Liben, , Czechia

La Roche Sur Yon Cedex 9, , France

Milan, Lombardia, Italy

Torrette, Marche, Italy

Torino, , Italy

Birmingham, , United Kingdom

La Roche Sur Yon, , France

San Miguel De Tucuman, , Argentina

Treviso, , Italy

La Plata, , Argentina

Garran, , Australia

Santo Andre, , Brazil

Sao Paulo, , Brazil

Kunming, , China

Nanjing, , China

Qingdao, , China

Shenyang, , China

Berlin, , Germany

Freiburg, , Germany

Torrette An, , Italy

Malmo, , Sweden

Patients applied

0 patients applied

Trial Officials

GSK Clinical Trials

Study Director

GlaxoSmithKline

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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