Clinical trialNCT07103746RecruitingPhase 2Interventional

Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment30Autoimmune Disorders

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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)

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Julie Paik, M.D., M.H.S.
Johns Hopkins Hospital: Division of Rheumatology
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama at Birmingham School of Medicine: Division of Clinical Immunology & Rheumatology
Birmingham, Alabama, United States
James Andrews, MD
Not, yet, recruiting
Emory University School of Medicine: Division of Rheumatology
Atlanta, Georgia, United States
Prateek Gandiga, MD
Not, yet, recruiting
University of Chicago, Department of Medicine: Rheumatology
Chicago, Illinois, United States
Iazsmin Ventura, MD
Not, yet, recruiting
Johns Hopkins Hospital: Division of Rheumatology
Baltimore, Maryland, United States
Julie Paik, MD
Recruiting
Mayo Clinic: Division of Rheumatology
Rochester, Minnesota, United States
Elie Naddaf, MD
Not, yet, recruiting
Northwell Health: Division of Rheumatology and Allergy-Clinical Immunology
Great Neck, New York, United States
Galina Marder, MD
Not, yet, recruiting
University of Pittsburgh Medical Center: Division of Rheumatology and Clinical Immunology
Pittsburgh, Pennsylvania, United States
Chester Oddis, MD
Not, yet, recruiting
University of Texas - Houston
Houston, Texas, United States
Eleni Tiniakou, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Placebo for UblituximabUblituximab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 21 Apr 2026
Primary completion: 31 Aug 2028
Completion: 31 Aug 2029
Last update posted: 10 Aug 2026
Registered enrollment: 30
Registry id: NCT07103746

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.