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Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab

Study acronym: ENHANCE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 20 words Secondary endpoints: details revised at 1 of 3 entries Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 3 entries
  2. Site details revised at 4 of 51 sitesv40
  3. Trial sites expanded: 47 → 51 locations Primary and study completion moved earlier from Dec 1, 2027 to Jan 21, 2027v39 Show 1 more changeShow less
    • Primary and study completion moved earlier from Dec 1, 2027 to Jan 21, 2027
  4. Site details revised at 2 of 47 sitesv38
  5. Re-verified, no change to tracked fieldsv37
Show 35 earlier versionsHide 35 earlier versions
  1. Study sites: 46 to 47v36
  2. Re-verified, no change to tracked fieldsv35
  3. Site details revised at 1 of 46 sitesv34
  4. Re-verified, no change to tracked fieldsv33
  5. Primary and study completion dates: Sep 1, 2026 to Dec 1, 2027 Primary endpoints revised (2) · Eligibility criteria expanded, about 34 words · Secondary endpoints revised (3) · 1 morev32 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints revised (3)
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  6. Primary and study completion dates: Mar 1, 2026 to Sep 1, 2026 Enrollment target: 600 to 800v31 Show 1 more changeShow less
    • Enrollment target: 600 to 800
  7. Re-verified, no change to tracked fieldsv30
  8. Study sites: 41 to 46v29
  9. Re-verified, no change to tracked fieldsv28
  10. Study sites: 40 to 41v27
  11. Study sites: 34 to 40v26
  12. Re-verified, no change to tracked fieldsv25
  13. Enrollment target: 300 to 600v24
  14. Primary endpoints: 1 to 2 Primary and study completion dates: Jun 1, 2026 to Mar 1, 2026 · Interventions: Ublituximab (Biological) to Placebo (Drug), Ublituximab (Biological) · Eligibility criteria expanded, about 39 words · 3 morev23 Show 6 more changesShow less
    • Primary and study completion dates: Jun 1, 2026 to Mar 1, 2026
    • Interventions: Ublituximab (Biological) to Placebo (Drug), Ublituximab (Biological)
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: 4 to 3
    • Study arms: 1 to 3
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  15. Primary and study completion dates: Jun 1, 2025 to Jun 1, 2026 Study sites: 33 to 34v22 Show 1 more changeShow less
    • Study sites: 33 to 34
  16. 2 versions Re-verified since Dec 26, 2024, no change to tracked fieldsv20-v21
  17. Study sites: 30 to 33v19
  18. Study sites: 28 to 30v18
  19. Study sites: 26 to 28 Secondary endpoints: details revised at 1 of 4 entriesv17 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 4 entries
  20. Study sites: 23 to 26 Eligibility criteria shortened, about 33 words · Secondary endpoints: 3 to 4 · Study title shortened, about 5 wordsv16 Show 3 more changesShow less
    • Eligibility criteria shortened, about 33 words
    • Secondary endpoints: 3 to 4
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  21. Re-verified, no change to tracked fieldsv15
  22. Study sites: 21 to 23v14
  23. Re-verified, no change to tracked fieldsv13
  24. Study sites: 20 to 21v12
  25. Study sites: 18 to 20 Primary and study completion dates: Jun 2025 to Jun 1, 2025v11 Show 1 more changeShow less
    • Primary and study completion dates: Jun 2025 to Jun 1, 2025
  26. Study sites: 16 to 18v10
  27. Study sites: 11 to 16v9
  28. Study sites: 9 to 11 Eligibility criteria shortened, about 131 words · Study title revisedv8 Show 2 more changesShow less
    • Eligibility criteria shortened, about 131 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  29. 2 versions Re-verified since Sep 18, 2023, no change to tracked fieldsv6-v7
  30. Study sites: 8 to 9 Eligibility criteria expanded, about 5 wordsv5 Show 1 more changeShow less
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  31. Study sites: 5 to 8v4
  32. Study sites: 2 to 5 Start date changed from estimate of May 2023 to Jun 13, 2023 · Secondary endpoints revised (3)v3 Show 2 more changesShow less
    • Start date changed from estimate of May 2023 to Jun 13, 2023
    • Secondary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

  33. Study title shortened, about 3 wordsv2 See this version in full on ClinicalTrials.gov ↗
  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 phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.
Trial Details
NCT Number NCT05877963
Lead Sponsor TG Therapeutics, Inc.
Conditions Relapsing Multiple Sclerosis
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov