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Trial record 2 of 2 for:    ULTIMATE, ublituximab

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)

This study is currently recruiting participants.
Verified September 2017 by TG Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03277248
First Posted: September 11, 2017
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
TG Therapeutics, Inc.
  Purpose
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 Intervention Phase
Relapsing Multiple Sclerosis (RMS) Biological: Ublituximab Drug: Teriflunomide Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by TG Therapeutics, Inc.:

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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 440
Actual Study Start Date: August 1, 2017
Estimated Study Completion Date: September 30, 2021
Estimated Primary Completion Date: March 31, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  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): NCT03277248


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

Locations
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, New York
TG Therapeutics RMS Investigational Trial Site Recruiting
Patchogue, New York, United States, 11772
Contact: TG Therapeutics Clinical Support Team    212-554-4484    RMSclinicalsuppot@tgtxinc.com   
Sponsors and Collaborators
TG Therapeutics, Inc.
  More Information

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03277248     History of Changes
Other Study ID Numbers: TG1101-RMS302
First Submitted: September 7, 2017
First Posted: September 11, 2017
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:
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