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

Who is this study for? Patients with Eosinophilic Granulomatosis With Polyangiitis
Status: Recruiting
Location: See all (79) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Colorado
GSK Investigational Site
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Denver
Florida
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Gainesville
Minnesota
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Rochester
North Carolina
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Charlotte
New York
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Manhasset
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New York
Oklahoma
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Tulsa
Pennsylvania
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Philadelphia
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Pittsburgh
Tennessee
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WITHDRAWN
Nashville
Virginia
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Norfolk
Other Locations
Argentina
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La Plata
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San Miguel De Tucumán
Austria
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Graz
Belgium
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Brussels
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Leuven
Brazil
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São Paulo
Canada
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Toronto
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Toronto
China
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COMPLETED
Beijing
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COMPLETED
Guangzhou
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WITHDRAWN
Guangzhou
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COMPLETED
Hefei
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COMPLETED
Nanjing
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COMPLETED
Qingdao
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COMPLETED
Shanghai
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COMPLETED
Shenzhen
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COMPLETED
Wenzhou
France
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Brest
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La Roche-sur-yon
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Lille
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Montpellier
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Nantes
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Paris
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Suresnes
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Toulouse
Germany
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Freiburg Im Breisgau
Hungary
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COMPLETED
Budapest
Israel
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Ramat Gan
Italy
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Bari
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Brescia
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Florence
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Milan
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Milan
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Pavia
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Pisa
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Roma
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Torrette An
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Treviso
Japan
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Kanagawa
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Kanagawa
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Saitama
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Tokyo
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Tokyo
Netherlands
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Groningen
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Leiden
Poland
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Gdansk
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Lodz
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Warsaw
Portugal
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Lisbon
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Porto
Republic of Korea
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Gwangju
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Jeonju
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Seoul
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Seoul
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Seoul
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Seoul
Spain
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Badalona
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Barcelona
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Barcelona
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Granada
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Granada
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Pamplona
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Valencia
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Zaragoza
Sweden
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Malmo
United Kingdom
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Birmingham
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Cambridge
GSK Investigational Site
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London
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2022-07-14
Estimated Completion Date: 2026-11-24
Participants
Target number of participants: 160
Treatments
Experimental: Participants receiving depemokimab+placebo matching mepolizumab
Active_comparator: Participants receiving mepolizumab+placebo matching depemokimab
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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