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TERMINATED
NCT05650567
PHASE2

Study of M5049 in DM and PM Participants (NEPTUNIA)

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

M5049 dose

Participants will receive film-coated tablets of M5049 dose orally, twice daily up to 24 weeks.

DRUG

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