National Institute of Allergy and Infectious Diseases (NIAID)
This is a multi-center, Phase 2 trial of ublituximab as first-line combination therapy in early, active autoantibody positive immune-mediated necrotizing myopathy. The primary objective is to estimate the effect of ublituximab as first add-on combination therapy at 24 weeks compared to placebo in treating early, active autoantibody positive immune-mediated necrotizing myopathy using the validated 2016 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Myositis Response Criteria, as measured by the Total Improvement Score (TIS)
Inclusion Criteria: 1. Participant must be able to understand and provide informed consent. 2. Age 18 years or older at disease onset. 3. Definite or probable IIM per the 2017 EULAR/ACR classification criteria. 4. Diagnosis of IMNM, meeting the 2016 ENMC classification criteria and having either of the following antibodies: 1. Anti-SRP 2. Anti-HMGCR 5. Early disease as defined as onset of objective muscle weakness assessed by a physician and/or CK elevation attributed to IMNM within 1 year of the time of informed consent. 6. Muscle weakness as assessed by an MMT-8 score \< 142 of 150 a…
Initial dose includes 150 mg dose followed by 450 mg two weeks later; maintenance dose is 450 mg
0.9% sodium chloride injection