RecruitingPhase 2NCT07103746

Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

30 participants

Start Date

Apr 21, 2026

Study Type

INTERVENTIONAL

Conditions

Autoimmune Disorders

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)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo for Ublituximab and a drug called Ublituximab for people with autoimmune disorders. The study is currently recruiting participants at 8 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUblituximab

Initial dose includes 150 mg dose followed by 450 mg two weeks later; maintenance dose is 450 mg

DRUGPlacebo for Ublituximab

0.9% sodium chloride injection

Locations(8)

University of Alabama at Birmingham School of Medicine: Division of Clinical Immunology & Rheumatology

Birmingham, Alabama, United States

Emory University School of Medicine: Division of Rheumatology

Atlanta, Georgia, United States

University of Chicago, Department of Medicine: Rheumatology

Chicago, Illinois, United States

Johns Hopkins Hospital: Division of Rheumatology

Baltimore, Maryland, United States

Mayo Clinic: Division of Rheumatology

Rochester, Minnesota, United States

Northwell Health: Division of Rheumatology and Allergy-Clinical Immunology

Great Neck, New York, United States

University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology

Pittsburgh, Pennsylvania, United States

University of Texas - Houston

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07103746

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