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Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 2 to 3 Eligibility criteria expanded, about 11 words · Secondary endpoints: details revised at 2 of 13 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 13 entries
  2. Re-verified, no change to tracked fieldsv9
  3. Study sites: 1 to 2v8
  4. Recruitment opened Start date changed from estimate of Aug 1, 2026 to Jul 1, 2026 · Site details revisedv7 Show 2 more changesShow less
    • Start date changed from estimate of Aug 1, 2026 to Jul 1, 2026
    • Site details revised
  5. Start date: Jun 1, 2026 to Aug 1, 2026 Study sites: 0 to 1v6 Show 1 more changeShow less
    • Study sites: 0 to 1
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Start date: Mar 31, 2026 to Jun 1, 2026v4
  3. Re-verified, no change to tracked fieldsv3
  4. Start date: Dec 1, 2025 to Mar 31, 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (\<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).
Trial Details
NCT Number NCT07220252
Lead Sponsor TG Therapeutics, Inc.
Conditions Relapsing Multiple Sclerosis
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov