NCT07103746

Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy

Study of Ublituximab in Early, Active, Autoantibody-Positive, IMMune-MedIated NecroTizing Myopathy (AIM01)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Autoimmune Disorders

Interventions

Type	Name	Description
DRUG	Ublituximab	Initial dose includes 150 mg dose followed by 450 mg two weeks later; maintenance dose is 450 mg
DRUG	Placebo for Ublituximab	0.9% sodium chloride injection

Timeline

• Start date: 2026-02-26
• Primary completion: 2028-08-01
• Completion: 2029-08-01
• First posted: 2025-08-05
• Last updated: 2026-04-08

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study