clinical trial · NCT07103746
Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy
National Institute of Allergy and Infectious Diseases (NIAID)·phase2·recruiting·n = 30
Autoimmune DisordersUblituximabPlacebo for Ublituximab
brief 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)
started
Feb 26, 2026
primary completion
Aug 1, 2028
completion
Aug 1, 2029
last updated
Apr 8, 2026
official title
Study of Ublituximab in Early, Active, Autoantibody-Positive, IMMune-MedIated NecroTizing Myopathy (AIM01)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol