Ublituximab for antibody-positive IMNM
Treatments studied
Part of Bones, joints & muscles, Brain & nervous system, Immune system & allergy clinical trials.
This study tests an investigational medication called ublituximab (an infusion) for people with a rare autoimmune muscle disease called IMNM. It aims to reduce muscle weakness and damage by targeting specific immune cells (B cells). To join, you need a recent diagnosis (within 1 year), specific antibodies, and be on limited other medications.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must be 18 or older and diagnosed with immune-mediated necrotizing myopathy (IMNM) with either anti-SRP or anti-HMGCR antibodies.
- Your muscle weakness or elevated muscle enzyme (CK) must have started within the last year.
- You need to have active muscle weakness and at least one other symptom, like doctor-rated disease activity or difficulty with daily tasks.
- You must be on only one of a few specific immunosuppressants (like methotrexate, mycophenolate, or azathioprine) at a stable dose for at least 12 weeks, and prednisone at 20 mg/day or less.
- You cannot have taken any B-cell depleting drugs (like rituximab) before, and you must avoid live vaccines within 4 weeks.
- You must agree to use highly effective birth control if applicable, and have no serious infections or other uncontrolled conditions.
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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