NCT07103746 · National Institute of Allergy and Infectious Diseases (NIAID)
Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy
(SUMMIT)
What this study is about
This is a multi-center, Phase 2 trial of ublituximab as first-line two or more treatments used together in early, active autoantibody positive immune-mediated necrotizing myopathy.
View original scientific description
This is a multi-center, Phase 2 trial of ublituximab as first-line combination therapy in early, active autoantibody positive immune-mediated necrotizing myopathy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participant must be able to understand and provide informed consent. 2. Age 18 years or older at disease onset. 3. Definite or probable IIM per the 2017 EULAR/ACR classification criteria. 4. Diagnosis of IMNM, meeting the 2016 ENMC classification criteria and having either of the following antibodies: 1. Anti-SRP 2. Anti-HMGCR 5. Early disease as defined as onset of objective muscle weakness assessed by a physician and/or CK elevation attributed to IMNM within 1 year of the time of informed consent. 6. Muscle weakness as assessed by an MMT-8 score \< 142 of 150 and CK \> 1.5x ULN along with abnormality in at least 1 of the following 4 CSMs at screening: 1. PhGA ≥ 2 cm 2. PtGA ≥ 2 cm 3. Extramuscular global assessment ≥ 2 cm 4. HAQ-DI ≥ 0.25 7. Only one background immunosuppressant treatment for IMNM. Permitted background therapy includes: a. Exactly one of the following with medication type stable for at least 12 weeks prior to randomizat
Where
- Birmingham, Alabama
- Atlanta, Georgia
- Chicago, Illinois
- Baltimore, Maryland
- Rochester, Minnesota
- Great Neck, New York
- Pittsburgh, Pennsylvania
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations