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Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy

NCT07103746 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-08

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Ublituximab

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

DRUG

Placebo for Ublituximab

0.9% sodium chloride injection

Sponsors & Collaborators

  • Autoimmunity Centers of Excellence

    collaborator OTHER

  • TG Therapeutics

    collaborator UNKNOWN

  • Rho Federal Systems Division, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Julie Paik, M.D., M.H.S. · Johns Hopkins Hospital: Division of Rheumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-26
Primary Completion
2028-08-31
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07103746 on ClinicalTrials.gov