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A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later May 30, 2027 → Jul 31, 2027
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from TG Therapeutics, Inc.

Record History

  1. Eligibility criteria expanded, about 10 words
  2. Primary completion pushed from May 30, 2027 to Jul 31, 2027v4
  3. Primary endpoint(s) modified Trial sites expanded: 36 → 39 locations · Primary completion moved earlier from Jul 31, 2027 to May 30, 2027 · Interventions: AI device (Device), Ublituximab (Drug), Ublituximab (Drug) to Prefilled pen (Device), Ublituximab (Drug), Ublituximab (Drug) · 1 morev3 Show 4 more changesShow less
    • Trial sites expanded: 36 → 39 locations
    • Primary completion moved earlier from Jul 31, 2027 to May 30, 2027
    • Interventions: AI device (Device), Ublituximab (Drug), Ublituximab (Drug) to Prefilled pen (Device), Ublituximab (Drug), Ublituximab (Drug)
    • Secondary endpoints: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  4. Recruitment opened Trial sites expanded: 0 → 36 locations · Start date changed from estimate of Mar 21, 2026 to Apr 1, 2026 · Interventions: AI Device (Device), Ublituximab (Drug), Ublituximab (Drug) to AI device (Device), Ublituximab (Drug), Ublituximab (Drug)v2 Show 3 more changesShow less
    • Trial sites expanded: 0 → 36 locations
    • Start date changed from estimate of Mar 21, 2026 to Apr 1, 2026
    • Interventions: AI Device (Device), Ublituximab (Drug), Ublituximab (Drug) to AI device (Device), Ublituximab (Drug), Ublituximab (Drug)
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.
Trial Details
NCT Number NCT07503873
Lead Sponsor TG Therapeutics, Inc.
Conditions Multiple Sclerosis
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov