Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy (NCT07103746)
Study of Ublituximab in Early, Active, Autoantibody-Positive, IMMune-MedIated NecroTizing Myopathy (AIM01)
🩺 Plain-English Summary (8th-Grade Level)
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)
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham School of Medicine: Division of Clinical Immunology & Rheumatology — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- University of Alabama at Birmingham School of Medicine: Division of Clinical Immunology & Rheumatology — Birmingham, Alabama
- Emory University School of Medicine: Division of Rheumatology — Atlanta, Georgia
- University of Chicago, Department of Medicine: Rheumatology — Chicago, Illinois
- Johns Hopkins Hospital: Division of Rheumatology — Baltimore, Maryland
- Mayo Clinic: Division of Rheumatology — Rochester, Minnesota
- Northwell Health: Division of Rheumatology and Allergy-Clinical Immunology — Great Neck, New York
- University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology — Pittsburgh, Pennsylvania
- University of Texas - Houston — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.