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Phase 2 Study of Ublituximab in Patients With Relapsing Forms of Multiple Sclerosis

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by TG Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02738775
First received: April 10, 2016
Last updated: January 9, 2017
Last verified: January 2017
  Purpose
This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis

Condition Intervention Phase
Multiple Sclerosis Biological: Ublituximab Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Multi-Center Phase 2 Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients With Relapsing Forms of Multiple Sclerosis.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • B-cell depletion [ Time Frame: Day 28 ]
    Measure B-cell depletion up to day 28

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months on therapy ]
    To determine the incidence of adverse events and any abnormal laboratory values


Secondary Outcome Measures:
  • Evaluate the % of relapses in relapsed multiple sclerosis patients [ Time Frame: up to 48 weeks ]

Estimated Enrollment: 40
Study Start Date: April 2016
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ublituximab
Ublituximab IV infusion dose on Day 1, 15 and Week 24
Biological: Ublituximab
Other Name: TG-1101
Placebo Comparator: Ublituximab Placebo
Placebo IV infusion dose on Day 1 and 15 only
Drug: Placebo

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of relapsed multiple sclerosis
  • Active disease
  • Greater than 1 relapse in prior 2 years

Exclusion Criteria:

  • Treatment with anti-CD20 monoclonal antibody within the last 12 months
  • Treatment with alemtuzumab within the last 12 months
  • Pregnant or nursing mothers
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02738775

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

Locations
United States, Arizona
TG Therapeutics Investigational Trial Site Recruiting
Phoenix, Arizona, United States, 85018
United States, California
TG Therapeutics Investigational Trial Site Recruiting
Pasedena, California, United States, 91105
United States, Colorado
TG Therapeutics Investigational Trial Site Recruiting
Aurora, Colorado, United States, 80045
TG Therapeutics Investigational Trial Site Recruiting
Fort Collins, Colorado, United States, 80528
United States, Kentucky
TG Therapeutics Investigational Trial Site Recruiting
Lexington, Kentucky, United States, 40509
United States, Ohio
TG Therapeutics Investigational Trial Site Recruiting
Columbus, Ohio, United States, 43201
United States, Tennessee
TG Therapeutics Investigational Trial Site Recruiting
Knoxville, Tennessee, United States, 37922
United States, Texas
TG Therapeutics Investigational Trial Site Recruiting
Round Rock, Texas, United States, 78681
TG Therapeutics Investigational Trial Site Recruiting
San Antonio, Texas, United States, 78258
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
Study Chair: Edward Fox, MD, PhD Central Texas Neurology
  More Information

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02738775     History of Changes
Other Study ID Numbers: TG1101-RMS-201
Study First Received: April 10, 2016
Last Updated: January 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be shared after study completion via publication

Keywords provided by TG Therapeutics, Inc.:
multiple sclerosis

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

ClinicalTrials.gov processed this record on September 19, 2017