Condition: Autoimmune Disorders · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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)
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| University of Alabama at Birmingham School of Medicine: Division of Clinical Immunology & Rheumatology | Birmingham, Alabama, United States | Not Yet Recruiting |
| Emory University School of Medicine: Division of Rheumatology | Atlanta, Georgia, United States | Not Yet Recruiting |
| University of Chicago, Department of Medicine: Rheumatology | Chicago, Illinois, United States | Not Yet Recruiting |
| Johns Hopkins Hospital: Division of Rheumatology | Baltimore, Maryland, United States | Recruiting |
| Mayo Clinic: Division of Rheumatology | Rochester, Minnesota, United States | Not Yet Recruiting |
| Northwell Health: Division of Rheumatology and Allergy-Clinical Immunology | Great Neck, New York, United States | Not Yet Recruiting |
| University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology | Pittsburgh, Pennsylvania, United States | Not Yet Recruiting |
| University of Texas - Houston | Houston, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07103746