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Study of M5049 in DM and PM Participants (NEPTUNIA)
Sponsor: EMD Serono Research & Development Institute, Inc.
Summary
The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.
Official title: A Phase IIa, Randomized, Parallel, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Enpatoran in Dermatomyositis and Polymyositis Participants Receiving Standard of Care (NEPTUNIA)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-01-19
Completion Date
2025-06-25
Last Updated
2026-09-09
Healthy Volunteers
No
Conditions
Interventions
M5049 dose
Participants will receive film-coated tablets of M5049 dose orally, twice daily up to 24 weeks.
Placebo
Participants will receive placebo matched to M5049 orally, twice daily up to 24 weeks.
Locations (31)
Neuromuscular Research Center
Phoenix, Arizona, United States
HonorHealth Research Institute - Bob Bove Neuroscience Institute-Neuroscience Research
Scottsdale, Arizona, United States
Mayo Clinic Scottsdale (6365)
Scottsdale, Arizona, United States
Barbara Davis Center
Aurora, Colorado, United States
HMD Research LLC
Orlando, Florida, United States
Bolanos Clinical Research
Pembroke Pines, Florida, United States
Augusta University-Rheumatology
Augusta, Georgia, United States
Johns Hopkins University - Department of Medicine, Division of Rheumatology
Baltimore, Maryland, United States
University of Minnesota-Dermatology
Minneapolis, Minnesota, United States
University of Kansas Medical Center-Neuromuscular
Kansas City, Missouri, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Austin Neuromuscular Center
Austin, Texas, United States
Nerve and Muscle Center of Texas-Clinical research
Houston, Texas, United States
Institute of Rheumatology - Rheumatology
Prague, Czechia
Hippokration Hospital - 2nd Department of Medicine and Laboratory
Athens, Greece
National and Kapodistrian University of Athens (Egnitio Hospital)
Athens, Greece
University General Hospital of Larissa
Larissa, Greece
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco Di Catania (Vittorio Emanuele) - Reumatologia
Catania, Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania, Italy
Azienda Usl Toscana Centro
Florence, Italy
Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Fondazione Policlinico Universitario A. Gemelli-IRCCS, UCSC - Scienze Mediche e Chirurgiche
Rome, Italy
Instytut Reumatologii im. Eleonory Reicher - Department of Connective Tissue Diseases
Warsaw, Poland
CHUAC - Complexo Hospitalario Universitario A Coruña - Rheumatology
A Coruña, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Universitario Ramon y Cajal, Madrid - Rheumatology Department
Madrid, Spain
Doncaster Royal Infirmary (3466)
Doncaster, United Kingdom
Royal Free London NHS Foundation Trust
London, United Kingdom
University College London Hospitals NHS Foundation Trust- Neuromuscular Diseases
London, United Kingdom
Salford Royal Hospital, Barnes Clinical Research Facility
Salford, United Kingdom
Royal Wolverhampton Hospitals (6493)
Wolverhampton, United Kingdom