Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07103746
Phase
PHASE2
Status
Recruiting
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Conditions

  • Autoimmune Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ublituximab — DRUG
    Initial dose includes 150 mg dose followed by 450 mg two weeks later; maintenance dose is 450 mg
  • Placebo for Ublituximab — DRUG
    0.9% sodium chloride injection

Study Details

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)

Key Dates

Start date
Feb 26, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Initial Ublituximab Active Group
    Receives 150 mg Ublituximab at Day 0 and 450 mg Ublituximab at Week 2, followed by 450 mgs of Ublituximab at Weeks 24 and 48. At Week 26, will receive a Placebo dose of 450 mg to maintain the blind.
  • Experimental: Initial Placebo of ublituximab Group
    Receives 150 mg Placebo at Day 0 and 450 mg Placebo at Week 2. Receives 150 mg Ublituximab at Week 24 followed by 450 mg Ublituximab at Weeks 26 and 48.

Primary Outcome Measure

The primary endpoint is the Total Improvement Score (TIS) at Week 24 reflecting the change from baseline [ Time Frame: Baseline to Week 24 ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham School of Medicine: Division of Clinical Immunology & RheumatologyBirminghamAlabama35233
James Andrews, MD (PRINCIPAL_INVESTIGATOR)
Emory University School of Medicine: Division of RheumatologyAtlantaGeorgia30322
Prateek Gandiga, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago, Department of Medicine: RheumatologyChicagoIllinois60637
Iazsmin Ventura, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins Hospital: Division of RheumatologyBaltimoreMaryland21244
Zuzana Bologna
[email protected]
706-284-3630
Julie Paik, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic: Division of RheumatologyRochesterMinnesota55905
Elie Naddaf, MD (PRINCIPAL_INVESTIGATOR)
Northwell Health: Division of Rheumatology and Allergy-Clinical ImmunologyGreat NeckNew York11021
Galina Marder, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical Center: Division of Rheumatology and Clinical ImmunologyPittsburghPennsylvania15261
Chester Oddis, MD (PRINCIPAL_INVESTIGATOR)
University of Texas - HoustonHoustonTexas77030
Enrique Rodriguez
[email protected]
713-500-4435
Eleni Tiniakou, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham School of Medicine: Division of Clinical Immunology & Rheumatology· Birmingham, ALEmory University School of Medicine: Division of Rheumatology· Atlanta, GAUniversity of Chicago, Department of Medicine: Rheumatology· Chicago, ILJohns Hopkins Hospital: Division of Rheumatology· Baltimore, MDMayo Clinic: Division of Rheumatology· Rochester, MNNorthwell Health: Division of Rheumatology and Allergy-Clinical Immunology· Great Neck, NY

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