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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 Compares to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 2)

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ClinicalTrials.gov Identifier: NCT03277248
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 II 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


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 specfied days or teriflunomide/ IV placebo (14mg, once daily starting on Week1 Day1)
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 specfied days or teriflunomide/ IV placebo (14mg, once daily starting on Week1 Day1)




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 v4.0 [ 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): NCT03277248


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

Locations
United States, Arizona
TG Therapeutics RMS Investigational Trial site Recruiting
Phoenix, Arizona, United States, 58018
Contact: TG Therapeutics Clinical Support Team    212-554-4484    RMSclinicalsupport@tgtxinc.com   
United States, Colorado
TG Therapeutics RMS Investigational Trial Site Recruiting
Aurora, Colorado, United States, 80045
Contact: TG Therapeutics Clinical Support Team    212-554-4484    RMSclinicalsupport@tgtxinc.com   
United States, Florida
TG Therapeutics RMS Investigational Trial Site Recruiting
Tampa, Florida, United States, 33612
Contact: TG Therapeutics Clinical Support Team    212-554-4484    RMSclinicalsupport@tgtxinc.com   
United States, Kentucky
TG Therapeutics RMS Investigational Trial Site Recruiting
Lexington, Kentucky, United States, 40513
Contact: TG Therapeutics Clinical Support Team    212-554-4484    RMSclinicalsupport@tgtxinc.com   
United States, Missouri
TG Therapeutics RMS Investigational Trial Site Recruiting
Chesterfield, Missouri, United States, 63017
Contact: TG Therapeutics Clinical Support Team    212-554-4484    RMSclinicalsupport@tgtxinc.com   
United States, Nevada
TG Therapeutics RMS Investigational Trial Site Recruiting
Las Vegas, Nevada, United States, 89106
Contact: TG Therapeutics Clinical Support Team    212-554-4484    RMSclinicalsupport@tgtxinc.com   
United States, New Jersey
TG Therapeutics RMS Investigational Trial Site Recruiting
Teaneck, New Jersey, United States, 07666
Contact: TG Therapeutics Clinical Support Team    212-554-4484    RMSclinicalsupport@tgtxinc.com   
United States, New Mexico
TG Therapeutics RMS Investigational Trial Site Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: TG Therapeutics Clinical Support Team    212-554-4484    RMSclinicalsupport@tgtxinc.com   
United States, New York
TG Therapeutics RMS Investigational Trial Site Recruiting
Patchogue, New York, United States, 11772
Contact: TG Therapeutics Clinical Support Team    212-554-4484    RMSclinicalsupport@tgtxinc.com   
United States, Ohio
TG Therapeutics RMS Investigational Trial site Recruiting
Columbus, Ohio, United States, 43221
Contact: TG Therapeutics Clinical Support Team    212-554-4484    RMSclinicalsupport@tgtxinc.com   
United States, Pennsylvania
TG Therapeutics RMS Investigational Trial Site Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: TG Therapeutics Clinical Support Team    212-554-4484    RMSclinicalsupport@tgtxinc.com   
United States, Texas
TG Therapeutics RMS Investigational Trial site Recruiting
San Antonio, Texas, United States, 78258
Contact: TG Therapeutics Clinical Support Team    212-554-4484    RMSclinicalsupport@tgtxinc.com   
United States, Washington
TG Therapeutics RMS Investigational Trial site Recruiting
Seattle, Washington, United States, 98122
Contact: TG Therapeutics Clinical Support Team    212-554-4484    RMSclinicalsupport@tgtxinc.com   
Sponsors and Collaborators
TG Therapeutics, Inc.

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03277248     History of Changes
Other Study ID Numbers: TG1101-RMS302
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