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NCT07789015Possibly a fitNot yet recruiting

Study of nerandomilast for active myositis

Idiopathic Inflammatory Myopathies

Treatments studied

Part of Bones, joints & muscles, Brain & nervous system clinical trials.

This study tests a new oral medication, nerandomilast, for people with active idiopathic inflammatory myopathies (a group of rare autoimmune diseases causing muscle weakness). It aims to see if the drug can reduce disease activity safely. Participants must have moderate-to-severe symptoms and be on standard treatments.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
270 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You must be 18 years or older.
  • You must have a confirmed diagnosis of idiopathic inflammatory myopathy (IIM) — a group of rare diseases causing muscle weakness and inflammation.
  • Your disease activity must be moderate to severe, based on specific muscle strength tests and skin scores.
  • You must be on a standard background treatment (e.g., steroids, methotrexate, azathioprine, or mycophenolate) with a stable dose.
  • You must not have certain exclusion conditions like recent major surgery, active cancer (except treated basal cell or in situ cervical cancer), or advanced lung disease.
  • If you are of childbearing potential, you must agree to use highly effective contraception during the study.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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