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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 : Completed
First Posted : September 11, 2017
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE September 7, 2017
First Posted Date  ICMJE September 11, 2017
Last Update Posted Date May 20, 2021
Actual Study Start Date  ICMJE August 1, 2017
Actual Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
Annualized Relapse Rate (ARR) [ Time Frame: 96 weeks on therapy ]
Measure the number of relapses per year per patient
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Relapsing Multiple Sclerosis (RMS)
Intervention  ICMJE
  • 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
  • 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)
Study Arms  ICMJE
  • Experimental: Ublituximab + Oral Placebo
    IV Infusion
    Intervention: Biological: Ublituximab
  • Active Comparator: Teriflunomide + IV Placebo
    Oral daily Administration
    Intervention: Drug: Teriflunomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2019)
500
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2017)
440
Actual Study Completion Date  ICMJE November 6, 2020
Actual Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03277261
Other Study ID Numbers  ICMJE TG1101-RMS301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TG Therapeutics, Inc.
Study Sponsor  ICMJE TG Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account TG Therapeutics, Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP