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Clinical Trials in the UK / NCT05263934
Active, not recruiting Phase 3

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

NCT05263934 · tracked via the Priya Life Science UK tracker
Sponsor
GlaxoSmithKline
Phase
Phase 3
Started
2022-07-14
Last updated
2026-07-08

Condition(s) studied

Eosinophilic Granulomatosis With Polyangiitis

Investigational drug(s) / intervention(s)

DepemokimabMepolizumabPlacebo matching mepolizumabPlacebo matching depemokimab

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.

Study summary

This study aims to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory EGPA receiving SoC therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (63)

FacilityCityRegionStatus
GSK Investigational Site Denver Colorado
GSK Investigational Site Gainesville Florida
GSK Investigational Site Rochester Minnesota
GSK Investigational Site New York New York
GSK Investigational Site Charlotte North Carolina
GSK Investigational Site Pittsburgh Pennsylvania
GSK Investigational Site La Plata Argentina
GSK Investigational Site San Miguel de Tucumán Argentina
GSK Investigational Site Graz Austria
GSK Investigational Site Santo André Brazil
GSK Investigational Site São Paulo Brazil
GSK Investigational Site Toronto Ontario
GSK Investigational Site Toronto Ontario
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 La Roche-sur-Yon France
GSK Investigational Site Nantes France
GSK Investigational Site Paris France
GSK Investigational Site Freiburg im Breisgau Germany
GSK Investigational Site Minden Germany
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
GSK Investigational Site Torrette AN Italy
GSK Investigational Site Treviso Italy
GSK Investigational Site Kanagawa Japan
GSK Investigational Site Kanagawa Japan
GSK Investigational Site Saitama Japan

+ 23 more sites — see the full list on the official registry below.

On this site

📄 Nucala (mepolizumab) drug profile →

More GlaxoSmithKline trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05263934 on ClinicalTrials.gov ↗ ← All trials in the UK