Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
Start Date
6/13/2023
Completion Date
12/1/2027
Summary
The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
Ublituximab
Placebo
Conditions
Locations
TG Therapeutics Investigational Trial Site
Birmingham, Alabama 35209
United States
TG Therapeutics Investigational Trial Site
Cullman, Alabama 35058
United States
TG Therapeutics Investigational Trial Site
Orange, California 92697
United States
TG Investigational Site
Fort Collins, Colorado 80528
United States
TG Therapeutics Investigational Trial Site
Washington D.C., District of Columbia 20007
United States
TG Therapeutics Investigational Trial Site
Tampa, Florida 33612
United States
TG Therapeutics Investigational Trial Site
Savannah, Georgia 31406
United States
TG Therapeutics Investigational Trial Site
Chicago, Illinois 60612
United States
TG Therapeutics Investigational Trial Site
Indianapolis, Indiana 46256
United States
TG Therapeutics Investigational Trial Site
Iowa City, Iowa 52242
United States
TG Therapeutics Investigational Trial Site
Overland Park, Kansas 66212
United States
TG Therapeutics Investigational Trial Site
Lutherville, Maryland 21093
United States
TG Therapeutics Investigational Trial Site
Boston, Massachusetts 00002
United States
TG Therapeutics Investigational Trial Site
Foxborough, Massachusetts 02035
United States
TG Therapeutics Investigational Trial Site
North Worcester, Massachusetts 01655
United States
TG Therapeutics Investigational Trial Site
Wellesley, Massachusetts 02481uni
United States
TG Investigational Site
Farmington, Michigan 48334
United States
TG Therapeutics Investigational Trial Site
Golden Valley, Minnesota 55422
United States
TG Therapeutics Investigational Trial Site
Plymouth, Minnesota 55446
United States
TG Therapeutics Investigational Trial Site
St Louis, Missouri 63131
United States
TG Therapeutics Investigational Trial Site
New York, New York 10025
United States
TG Therapeutics Investigational Trial Site
New York, New York 11021
United States
TG Therapeutics Investigational Trial SiteCharlotte
Charlotte, North Carolina 28204
United States
TG Therapeutics Investigational Trial Site
Raleigh, North Carolina 27607
United States
TG Therapeutics Investigational Trial Site
Cleveland, Ohio 44195
United States
TG Therapeutics Investigational Trial Site
Dayton, Ohio 45417
United States
TG Therapeutics Investigational Trial Site
Oklahoma City, Oklahoma 73104
United States
TG Therapeutics Investigational Trial Site
Greenville, South Carolina 29605
United States
TG Therapeutics Investigational Trial Site
Knoxville, Tennessee 37922
United States
TG Therapeutics Investigational Trial Site
Houston, Texas 77030
United States
TG Therapeutics Investigational Trial Site
Salt Lake City, Utah 84103
United States
TG Therapeutics Investigational Trial Site
Vienna, Virginia 22182
United States
TG Therapeutics Investigational Trial Site
Kirkland, Washington 98034
United States
TG Therapeutics Investigational Trial Site
Seattle, Washington 98109
United States
TG Therapeutics Investigational Trial Site
Spokane, Washington 99208
United States
TG Therapeutics Investigational Trial Site
Milwaukee, Wisconsin 53226
United States
TG Therapeutics Investigational Trial Site
Bydgoszcz,
Poland
TG Therapeutics Investigational Trial Site
Katowice, 40-555
Poland
TG Therapeutics Investigational Trial Site
Katowice,
Poland
TG Therapeutics Investigational Trial Site
Kielce,
Poland
TG Therapeutics Investigational Trial Site
Krakow, 31-826
Poland
TG Therapeutics Investigational Trial Site
Lodz,
Poland
TG Therapeutics Investigational Trial Site
Olsztyn, 10-561
Poland
TG Therapeutics Investigational Trial Site
Poznan,
Poland
TG Therapeutics Investigational Trial Site
Warsaw, 04-141
Poland
TG Therapeutics Investigational Trial Site
Zabrze,
Poland
TG Therapeutics Investigational Trial Site
Żory, 44-240
Poland