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Neptunia 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
Recruiting
Dermatomyositis (DM) and Polymyositis (PM) are both autoimmune diseases. In autoimmune diseases, the body’s immune system, which normally protects us against infection and illness, starts to attack the body’s own cells instead. The main purpose of this research study is to see whether an investigational drug called enpatoran (referred to as the “study drug”) works better than placebo to improve symptoms in people with DM or PM. A “placebo” looks like the study drug but does not have any active substance in it. Researchers also hope to find out more about how safe the study drug is and how well tolerated it is.
Male or Female
18 years and over
Inclusion Criteria:
• adults with primarily diagnosed with Dermatomyositis (DM) or Polymyositis (PM)
Exclusion Criteria:
• diagnosis of myositis within 3 years of cancer
• malignancy-associated or juvenile DM
Drug: M5049 high dose, Drug: Placebo
Dermatology (Skin, Hair & Nails)
Dermatomyositis (DM), Polymyositis (PM)
Irmina Wallander - wall0396@umn.edu
David Pearson
PHASE2
SITE00001761
See this study on ClinicalTrials.gov