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Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

A 52-week, Randomized, Double-blind, Double-dummy, Parallel-group, Multi-centre, Non-inferiority Study to Investigate the Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) Receiving Standard of Care (SoC) Therapy

NCT05263934•GlaxoSmithKline

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

Locations (76)

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Gainesville, Florida, United States

GSK Investigational Site

Rochester, Minnesota, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Tulsa, Oklahoma, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Norfolk, Virginia, United States

GSK Investigational Site

La Plata, Argentina

Key Dates

Start Date

July 14, 2022

Primary Completion Date

September 29, 2026

Completion Date

October 27, 2026

Last Updated

November 20, 2025

Enrollment

163

ACTUAL participants

Conditions

Eosinophilic Granulomatosis With Polyangiitis

Interventions

Depemokimab

BIOLOGICAL

Mepolizumab

BIOLOGICAL

Placebo matching mepolizumab

DRUG

Placebo matching depemokimab

DRUG

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

NCT03004326

Cryoglobulinemic Vasculitis (CV)Drug-induced Vasculitis+8 more

View study

RECRUITINGPHASE2/PHASE3

A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）

NCT05979051

Eosinophilic Granulomatosis With Polyangiitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）

Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis

Beyond EOsinophils: proteoMICS to Identify Potential Biomarker of Organ Damage and Response to MEPOLIZUMAB in EGPA

NUCALA® Special Drug Use Investigation (EGPA, Long-term)

The Epigenomic Signature of Eosinophilic Granulomatosis With Polyangiitis