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: Active_not_recruiting
Location: See all (76) 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) 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

Locations
United States
Colorado
GSK Investigational Site
Denver
Florida
GSK Investigational Site
Gainesville
Minnesota
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Rochester
North Carolina
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Charlotte
New York
GSK Investigational Site
New York
Oklahoma
GSK Investigational Site
Tulsa
Pennsylvania
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Philadelphia
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Pittsburgh
Virginia
GSK Investigational Site
Norfolk
Other Locations
Argentina
GSK Investigational Site
La Plata
GSK Investigational Site
San Miguel De Tucumán
Austria
GSK Investigational Site
Graz
Belgium
GSK Investigational Site
Brussels
GSK Investigational Site
Leuven
Brazil
GSK Investigational Site
São Paulo
Canada
GSK Investigational Site
Toronto
GSK Investigational Site
Toronto
China
GSK Investigational Site
Beijing
GSK Investigational Site
Guangzhou
GSK Investigational Site
Hefei
GSK Investigational Site
Nanjing
GSK Investigational Site
Qingdao
GSK Investigational Site
Shanghai
GSK Investigational Site
Shenzhen
GSK Investigational Site
Wenzhou
France
GSK Investigational Site
Brest
GSK Investigational Site
La Roche-sur-yon
GSK Investigational Site
Lille
GSK Investigational Site
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
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Minden
Hungary
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Budapest
Israel
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Ramat Gan
Italy
GSK Investigational Site
Bari
GSK Investigational Site
Brescia
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Florence
GSK Investigational Site
Milan
GSK Investigational Site
Milan
GSK Investigational Site
Pavia
GSK Investigational Site
Pisa
GSK Investigational Site
Roma
GSK Investigational Site
Torrette An
GSK Investigational Site
Treviso
Japan
GSK Investigational Site
Kanagawa
GSK Investigational Site
Kanagawa
GSK Investigational Site
Saitama
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
Netherlands
GSK Investigational Site
Groningen
GSK Investigational Site
Leiden
Poland
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Gdansk
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Lodz
GSK Investigational Site
Warsaw
Portugal
GSK Investigational Site
Lisbon
GSK Investigational Site
Porto
Republic of Korea
GSK Investigational Site
Gwangju
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
Spain
GSK Investigational Site
Badalona
GSK Investigational Site
Barcelona
GSK Investigational Site
Barcelona
GSK Investigational Site
Granada
GSK Investigational Site
Granada
GSK Investigational Site
Pamplona
GSK Investigational Site
Valencia
GSK Investigational Site
Zaragoza
Sweden
GSK Investigational Site
Malmo
United Kingdom
GSK Investigational Site
Birmingham
GSK Investigational Site
Cambridge
GSK Investigational Site
London
Time Frame
Start Date: 2022-07-14
Completion Date: 2026-10-27
Participants
Target number of participants: 163
Treatments
Experimental: Participants receiving depemokimab+placebo matching mepolizumab
Active_comparator: Participants receiving mepolizumab+placebo matching depemokimab
Authors
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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