drugset / Trial / NCT07103746
Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy
Phase 2
Recruiting
30 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Autoimmunity Centers of Excellence · collabRho Federal Systems Division, Inc. · collabTG Therapeutics, Inc. · collab
RandomizedParallel-groupTriple-blindTreatment
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)
Timeline
- Start
- 2026-02-26
- Primary completion
- 2028-08
- Completion
- 2029-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ublituximab | Monoclonal antibody | 450 mg | — |