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Trial record 1 of 2 for:    ULTIMATE, ublituximab
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A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compared to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 1)

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ClinicalTrials.gov Identifier: NCT03277261
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a Phase 3, randomized, multi-center, double-blinded, active-controlled study that is primarily designed to assess the Annualized Relapse Rate (ARR) and safety/tolerability of ublituximab/oral placebo (TG-1101; UTX) as compared to teriflunomide/IV placebo in subjects with Relapsing MS.

Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis (RMS) Biological: Ublituximab Drug: Teriflunomide Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, multi-center, double-blinded, active-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blinded, active-controlled study
Primary Purpose: Treatment
Official Title: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY)
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ublituximab + Oral Placebo
IV Infusion
Biological: Ublituximab
Subjects will be randomized in a [1:1] ratio to receive either ublituximab/oral placebo on specified days or teriflunomide/IV placebo (14 mg, OD starting on Week 1 Day 1)
Other Name: TG-1101
Active Comparator: Teriflunomide + IV Placebo
Oral daily Administration
Drug: Teriflunomide
Subjects will be randomized in a [1:1] ratio to receive either ublituximab/oral placebo on specified days or teriflunomide/IV placebo (14 mg, OD starting on Week 1 Day 1)

Outcome Measures

Primary Outcome Measures :
  1. Annualized Relapse Rate (ARR) [ Time Frame: 96 weeks on therapy ]
    Measure the number of relapses per year per patient

Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE V 4.0 [ Time Frame: 96 weeks on therapy ]
    To determine the incidence of adverse events and any abnormal laboratory values

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18-55 age
  • Diagnosis of RMS (McDonald criteria 2010)
  • Active disease
  • Expanded disability status scale (EDSS) 0-5.5 (inclusive) at screening

Exclusion Criteria:

  • Treatment with prior Anti-CD20 or other B cell directed treatment
  • Treatment with the following therapies at any time prior to randomization: Alemtuzumab, Natalizumab, Teriflunomide, Leflunomide and Stem cell transplantation
  • Diagnosed with Primary Progressive MS (PPMS)
  • Pregnant or nursing
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277261

Contact: TG Therapeutics Clinical Support Team 212-554-4484 RMSclinicalsupport@tgtxinc.com

United States, Tennessee
TG Therapeutics RMS Investigational Trial Site Recruiting
Knoxville, Tennessee, United States, 37922
Sponsors and Collaborators
TG Therapeutics, Inc.
More Information

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03277261     History of Changes
Other Study ID Numbers: TG1101-RMS301
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases