Actively Recruiting
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
Led by TG Therapeutics, Inc. · Updated on 2026-05-12
800
Participants Needed
46
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsing multiple sclerosis according to the 2017 Revised McDonald criteria
- Participants must be either treatment-naive or previously treated with a disease modifying therapy and meet washout requirements
- Expanded Disability Status Scale (EDSS) score of 5.5 or less at screening
- Neurologically stable for more than 30 days before first ublituximab dose
- Female participants of childbearing potential must agree to use contraception during the study and for 6 months after the last dose
- For Part C: currently treated with an anti-CD20 agent for at least 6 months and meet washout requirements before study start
- For Part C: discontinuation of current anti-CD20 therapy due to suboptimal experience
You will not qualify if you...
- History of any serious infusion-related reaction on prior anti-CD20 therapy
- Diagnosis of primary-progressive multiple sclerosis or inactive secondary progressive MS
- Active chronic or treated immune system diseases other than MS, or immunodeficiency syndromes
- Current or history of significant infections requiring long-term systemic treatment
- Previous serious opportunistic or atypical infections
- Evidence or history of hepatitis B or chronic hepatitis C infection unless PCR negative for HCV RNA
- History or evidence of progressive multifocal leukoencephalopathy (PML)
- Receipt of live or live-attenuated vaccines within 4 weeks before first study drug dose
- Need for intravenous immune globulin treatment for low immunoglobulins within 12 months before study start
- Any active malignancies except adequately treated basal, squamous cell, or in situ carcinoma
- Prior treatment with ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 46 locations
1
TG Therapeutics Investigational Trial Site
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
TG Therapeutics Investigational Trial Site
Cullman, Alabama, United States, 35058
Actively Recruiting
3
TG Therapeutics Investigational Trial Site
Orange, California, United States, 92697
Actively Recruiting
4
TG Investigational Site
Fort Collins, Colorado, United States, 80528
Actively Recruiting
5
TG Therapeutics Investigational Trial Site
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
6
TG Therapeutics Investigational Trial Site
Tampa, Florida, United States, 33612
Actively Recruiting
7
TG Therapeutics Investigational Trial Site
Chicago, Illinois, United States, 60612
Actively Recruiting
8
TG Therapeutics Investigational Trial Site
Indianapolis, Indiana, United States, 46256
Actively Recruiting
9
TG Therapeutics Investigational Trial Site
Iowa City, Iowa, United States, 52242
Actively Recruiting
10
TG Therapeutics Investigational Trial Site
Overland Park, Kansas, United States, 66212
Actively Recruiting
11
TG Therapeutics Investigational Trial Site
Lutherville, Maryland, United States, 21093
Actively Recruiting
12
TG Therapeutics Investigational Trial Site
Boston, Massachusetts, United States, 00002
Actively Recruiting
13
TG Therapeutics Investigational Trial Site
Foxborough, Massachusetts, United States, 02035
Actively Recruiting
14
TG Therapeutics Investigational Trial Site
North Worcester, Massachusetts, United States, 01655
Actively Recruiting
15
TG Therapeutics Investigational Trial Site
Wellesley, Massachusetts, United States, 02481uni
Actively Recruiting
16
TG Investigational Site
Farmington, Michigan, United States, 48334
Actively Recruiting
17
TG Therapeutics Investigational Trial Site
Golden Valley, Minnesota, United States, 55422
Actively Recruiting
18
TG Therapeutics Investigational Trial Site
Plymouth, Minnesota, United States, 55446
Actively Recruiting
19
TG Therapeutics Investigational Trial Site
St Louis, Missouri, United States, 63131
Actively Recruiting
20
TG Therapeutics Investigational Trial Site
New York, New York, United States, 10025
Actively Recruiting
21
TG Therapeutics Investigational Trial Site
New York, New York, United States, 11021
Actively Recruiting
22
TG Therapeutics Investigational Trial SiteCharlotte
Charlotte, North Carolina, United States, 28204
Actively Recruiting
23
TG Therapeutics Investigational Trial Site
Raleigh, North Carolina, United States, 27607
Actively Recruiting
24
TG Therapeutics Investigational Trial Site
Cleveland, Ohio, United States, 44195
Actively Recruiting
25
TG Therapeutics Investigational Trial Site
Dayton, Ohio, United States, 45417
Actively Recruiting
26
TG Therapeutics Investigational Trial Site
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
27
TG Therapeutics Investigational Trial Site
Greenville, South Carolina, United States, 29605
Actively Recruiting
28
TG Therapeutics Investigational Trial Site
Knoxville, Tennessee, United States, 37922
Actively Recruiting
29
TG Therapeutics Investigational Trial Site
Houston, Texas, United States, 77030
Active, Not Recruiting
30
TG Therapeutics Investigational Trial Site
Salt Lake City, Utah, United States, 84103
Actively Recruiting
31
TG Therapeutics Investigational Trial Site
Vienna, Virginia, United States, 22182
Actively Recruiting
32
TG Therapeutics Investigational Trial Site
Kirkland, Washington, United States, 98034
Actively Recruiting
33
TG Therapeutics Investigational Trial Site
Seattle, Washington, United States, 98109
Actively Recruiting
34
TG Therapeutics Investigational Trial Site
Spokane, Washington, United States, 99208
Actively Recruiting
35
TG Therapeutics Investigational Trial Site
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
36
TG Therapeutics Investigational Trial Site
Bydgoszcz, Poland
Actively Recruiting
37
TG Therapeutics Investigational Trial Site
Katowice, Poland, 40-555
Actively Recruiting
38
TG Therapeutics Investigational Trial Site
Katowice, Poland
Actively Recruiting
39
TG Therapeutics Investigational Trial Site
Kielce, Poland
Actively Recruiting
40
TG Therapeutics Investigational Trial Site
Krakow, Poland, 31-826
Actively Recruiting
41
TG Therapeutics Investigational Trial Site
Lodz, Poland
Actively Recruiting
42
TG Therapeutics Investigational Trial Site
Olsztyn, Poland, 10-561
Actively Recruiting
43
TG Therapeutics Investigational Trial Site
Poznan, Poland
Actively Recruiting
44
TG Therapeutics Investigational Trial Site
Warsaw, Poland, 04-141
Actively Recruiting
45
TG Therapeutics Investigational Trial Site
Zabrze, Poland
Actively Recruiting
46
TG Therapeutics Investigational Trial Site
Żory, Poland, 44-240
Actively Recruiting
Research Team
T
TG Therapeutics Clinical Support Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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