Clinical Trial

Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy

Study acronym: SUMMIT
Recruiting Phase 2
View on ClinicalTrials.gov →
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)
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-08-01; most recent amendment 2026-06-12.
Status change: Not Yet Recruiting → Recruiting 2026-03-09
Trial Details
NCT Number NCT07103746
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Autoimmunity Centers of Excellence, TG Therapeutics, Rho Federal Systems Division, Inc.
Conditions Autoimmune Disorders
Enrollment 30 participants
Start Date 2026-04-21
Primary Completion 2028-08 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-10