Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy
Status:
NOT_YET_RECRUITING
Trial end date:
2030-06-01
Target enrollment:
Participant gender:
Summary
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)
Phase:
PHASE2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Autoimmunity Centers of Excellence Rho Federal Systems Division, Inc. TG Therapeutics