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Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )

NCT03277261 · ULTIMATE 1 Phase 3Completed

Lead sponsor
TG Therapeutics, Inc. (Industry)
Enrollment
549 (actual)
Start date
19 Sep 2017
Primary completion
23 Jul 2020 (actual)
Study completion
6 Nov 2020
Last update posted
6 Dec 2021

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
2

Interventions

  • Ublituximab Biological
  • Teriflunomide Drug
  • Oral Placebo Drug
  • IV Placebo Drug

Conditions and primary outcome

  • Relapsing Multiple Sclerosis (RMS)

Primary outcome

Annualized Relapse Rate (ARR) (Up to 96 weeks)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03277261 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Annualized Relapse Rate (ARR)

    Time frame
    Up to 96 weeks
    Measure
    Least squares mean
    Unit
    relapses per participant-years

    • Ublituximab + Oral Placebo vs Teriflunomide + IV PlaceboSuperiority

      Estimate
      0.406Rate Ratio (Ublituximab/Teriflunomide)
      95% CI, two-sided
      0.268 to 0.615
      p-value
      <0.0001
      Method
      Negative Binomial Model

Serious adverse events

Time frame: From the first dose of study drug through the end of the study (up to approximately 116 weeks)

Participants with serious adverse events per group for ULTIMATE 1, as posted
GroupAffectedAt risk
Ublituximab + Oral Placebo31273
Teriflunomide + IV Placebo19275

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

4 on PubMed

  1. Efficacy of Ublituximab in People with Highly Active Relapsing Multiple Sclerosis.

    Neurology and therapy · 2026 Jun

    PubMed 41787239 (opens in a new tab)DOI 10.1007/s40120-026-00904-4 (opens in a new tab)

  2. Disease outcomes with ublituximab in treatment-naïve participants: subpopulation analyses of the phase 3 ULTIMATE I and II studies in participants with relapsing multiple sclerosis.

    Frontiers in immunology · 2026

    PubMed 42292352 (opens in a new tab)DOI 10.3389/fimmu.2026.1771848 (opens in a new tab)

  3. Improvements in no evidence of disease activity with ublituximab vs. teriflunomide in the ULTIMATE phase 3 studies in relapsing multiple sclerosis.

    Frontiers in neurology · 2024

    PubMed 39512280 (opens in a new tab)DOI 10.3389/fneur.2024.1473284 (opens in a new tab)

  4. Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis.

    The New England journal of medicine · 2022 Aug 25

    PubMed 36001711 (opens in a new tab)DOI 10.1056/NEJMoa2201904 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.