Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA)
NCT ID: NCT05263934
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
163 participants
INTERVENTIONAL
2022-07-14
2026-10-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Participants receiving depemokimab+placebo matching mepolizumab
Depemokimab
Depemokimab will be administered
Placebo matching mepolizumab
Placebo matching to mepolizumab will be administered.
Participants receiving mepolizumab+placebo matching depemokimab
Mepolizumab
Mepolizumab will be administered
Placebo matching depemokimab
Placebo matching to depemokimab will be administered.
Interventions
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Depemokimab
Depemokimab will be administered
Mepolizumab
Mepolizumab will be administered
Placebo matching mepolizumab
Placebo matching to mepolizumab will be administered.
Placebo matching depemokimab
Placebo matching to depemokimab will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Gainesville, Florida, United States
GSK Investigational Site
Rochester, Minnesota, United States
GSK Investigational Site
Manhasset, New York, United States
GSK Investigational Site
New York, New York, United States
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Charlotte, North Carolina, United States
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Tulsa, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Norfolk, Virginia, United States
GSK Investigational Site
La Plata, , Argentina
GSK Investigational Site
San Miguel de Tucumán, , Argentina
GSK Investigational Site
Graz, , Austria
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Brussels, , Belgium
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Leuven, , Belgium
GSK Investigational Site
São Paulo, , Brazil
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Beijing, , China
GSK Investigational Site
Guangzhou, , China
GSK Investigational Site
Hefei, , China
GSK Investigational Site
Nanjing, , China
GSK Investigational Site
Qingdao, , China
GSK Investigational Site
Shanghai, , China
GSK Investigational Site
Shenzhen, , China
GSK Investigational Site
Wenzhou, , China
GSK Investigational Site
Brest, , France
GSK Investigational Site
La Roche-sur-Yon, , France
GSK Investigational Site
Lille, , France
GSK Investigational Site
Montpellier, , France
GSK Investigational Site
Nantes, , France
GSK Investigational Site
Paris, , France
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Suresnes, , France
GSK Investigational Site
Toulouse, , France
GSK Investigational Site
Freiburg im Breisgau, , Germany
GSK Investigational Site
Budapest, , Hungary
GSK Investigational Site
Ramat Gan, , Israel
GSK Investigational Site
Bari, , Italy
GSK Investigational Site
Brescia, , Italy
GSK Investigational Site
Florence, , Italy
GSK Investigational Site
Milan, , Italy
GSK Investigational Site
Milan, , Italy
GSK Investigational Site
Pavia, , Italy
GSK Investigational Site
Pisa, , Italy
GSK Investigational Site
Roma, , Italy
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Torrette AN, , Italy
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Treviso, , Italy
GSK Investigational Site
Kanagawa, , Japan
GSK Investigational Site
Kanagawa, , Japan
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Saitama, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
GSK Investigational Site
Groningen, , Netherlands
GSK Investigational Site
Leiden, , Netherlands
GSK Investigational Site
Gdansk, , Poland
GSK Investigational Site
Lodz, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Lisbon, , Portugal
GSK Investigational Site
Porto, , Portugal
GSK Investigational Site
Gwangju, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Badalona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Granada, , Spain
GSK Investigational Site
Granada, , Spain
GSK Investigational Site
Pamplona, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Zaragoza, , Spain
GSK Investigational Site
Malmo, , Sweden
GSK Investigational Site
Birmingham, , United Kingdom
GSK Investigational Site
Cambridge, , United Kingdom
GSK Investigational Site
London, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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217102
Identifier Type: -
Identifier Source: org_study_id