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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Trial Officials
GSK Clinical Trials
Study Director
GlaxoSmithKline
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials