Actively Recruiting
Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-08
30
Participants Needed
8
Research Sites
178 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
A
Autoimmunity Centers of Excellence
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent
- Age 18 years or older at disease onset
- Definite or probable idiopathic inflammatory myopathy per 2017 EULAR/ACR criteria
- Diagnosis of immune-mediated necrotizing myopathy (IMNM) with anti-SRP or anti-HMGCR antibodies
- Early disease with muscle weakness or CK elevation within 1 year before consent
- Muscle weakness with MMT-8 score less than 142 of 150 and CK above 1.5 times upper limit of normal
- Abnormality in at least one of these at screening: physician global assessment, patient global assessment, extramuscular assessment, or HAQ-DI
- Treatment with one specified immunosuppressant medication at stable dose for at least 12 weeks
- Current glucocorticoid therapy 20 mg/day prednisone or less, stable for at least 4 weeks, or stopped at least 4 weeks before consent
- Agreement to use FDA-approved effective contraception for females of reproductive potential and males with partners of reproductive potential during study and 6 months after
- Negative pregnancy test at screening and baseline for females of reproductive potential
You will not qualify if you...
- End-stage myositis with severe organ involvement or advanced lung disease
- Irreversible muscle damage or severe atrophy causing additional risk or assessment difficulty
- Uncontrolled interstitial lung disease or other uncontrolled idiopathic inflammatory myopathy manifestations
- Other inflammatory or noninflammatory myopathies, including antibody-negative IMNM, inclusion body myositis, overlap myositis, metabolic myopathies, muscular dystrophies, drug-induced or cancer-associated myositis
- Severe liver disease with ascites or encephalopathy
- History of malignancy except cured non-melanoma skin cancer with no recurrence for 5 years
- Recent or ongoing infections needing systemic treatment within 14 days before consent
- Current suppressive therapy for chronic infections like herpes simplex virus
- Active or latent tuberculosis infection as determined by testing
- Chronic infections including HIV, hepatitis B or C (with negative viral load if hepatitis C antibody positive)
- Known allergy to ublituximab
- Recent live or live-attenuated vaccines within 4 weeks or other vaccines within 2 weeks before consent
- Low blood counts or kidney function below specified thresholds
- Treatment with certain immunosuppressive agents or B-cell depleting drugs within 12 weeks or prior receipt at any time
- Recent use of intravenous or subcutaneous immunoglobulin within 12 weeks or more than one prior cycle
- History of substance abuse within 12 months
- Pregnancy, lactation, or intent to become pregnant during the study
- Use of investigational drugs within 24 weeks before consent
- Other medical conditions or findings that may increase risk, interfere with study, or affect data quality per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
University of Alabama at Birmingham School of Medicine: Division of Clinical Immunology & Rheumatology
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
Emory University School of Medicine: Division of Rheumatology
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
3
University of Chicago, Department of Medicine: Rheumatology
Chicago, Illinois, United States, 60637
Not Yet Recruiting
4
Johns Hopkins Hospital: Division of Rheumatology
Baltimore, Maryland, United States, 21244
Actively Recruiting
5
Mayo Clinic: Division of Rheumatology
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
6
Northwell Health: Division of Rheumatology and Allergy-Clinical Immunology
Great Neck, New York, United States, 11021
Not Yet Recruiting
7
University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology
Pittsburgh, Pennsylvania, United States, 15261
Not Yet Recruiting
8
University of Texas - Houston
Houston, Texas, United States, 77030
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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