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Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy

Study acronym: SUMMIT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 37 words Secondary endpoints: details revised at 4 of 15 entries · Site details revised at 2 of 8 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 4 of 15 entries
    • Site details revised at 2 of 8 sites
  2. Site details revised at 1 of 8 sitesv7
  3. Start date: Feb 26, 2026 to Apr 21, 2026v6
  4. Site details revised at 1 of 8 sitesv5
  5. Study sites: 9 to 8v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Study sites: 2 to 9 · Primary completion date: Jun 2029 to Aug 2028 · Completion date: Jun 2030 to Aug 2029 · 3 morev3 Show 6 more changesShow less
    • Study sites: 2 to 9
    • Primary completion date: Jun 2029 to Aug 2028
    • Completion date: Jun 2030 to Aug 2029
    • Start date changed from estimate of Jan 2026 to Feb 26, 2026
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints revised (15)

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Nov 2025 to Jan 2026v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT07103746
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Autoimmunity Centers of Excellence, TG Therapeutics, Rho Federal Systems Division, Inc.
Conditions Autoimmune Disorders
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov