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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 : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

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 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

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)



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



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

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

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


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

Locations
United States, California
TG Therapeutics RMS Investigational Trial Site Recruiting
Carlsbad, California, United States, 92001
TG Therapeutics RMS Investigational Trial Site Recruiting
Long Beach, California, United States, 90808
TG Therapeutics RMS Investigational Trial Site Recruiting
Pasadena, California, United States, 91105
TG Therapeutics RMS Investigational Trial Site Recruiting
Stanford, California, United States, 94305
United States, Florida
TG Therapeutics RMS Investigational Trial Site Recruiting
Miami, Florida, United States, 33136
United States, Illinois
TG Therapeutics RMS Investigational Trial Site Recruiting
Northbrook, Illinois, United States, 60062
United States, Kansas
TG Therapeutics RMS Investigational Trial Site Recruiting
Kansas City, Kansas, United States, 66160
United States, Michigan
TG Therapeutics RMS Investigational Trial Site Recruiting
Detroit, Michigan, United States, 48201
United States, New York
TG Therapeutics RMS Investigational Trial Site Recruiting
Amherst, New York, United States, 14226
United States, Ohio
TG Therapeutics RMS Investigational Trial Site Recruiting
Westerville, Ohio, United States, 43081
United States, Tennessee
TG Therapeutics RMS Investigational Trial Site Recruiting
Franklin, Tennessee, United States, 37064
TG Therapeutics RMS Investigational Trial Site Recruiting
Knoxville, Tennessee, United States, 37922
United States, Texas
TG Therapeutics RMS Investigational Trial Site Recruiting
Dallas, Texas, United States, 75246
TG Therapeutics RMS Investigational Site Recruiting
Round Rock, Texas, United States, 78681
Sponsors and Collaborators
TG Therapeutics, Inc.

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: March 1, 2018
Last Verified: February 2018

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

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