Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
Condition(s) studied
Investigational drug(s) / intervention(s)
Ublituximab: Administered as an intravenous (IV) infusion.
Placebo: IV infusion
Study 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
Primary outcome measure(s)
- Part A and Part C: Percentage of Participants With no Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48 — Baseline up to Week 48
The Gd-enhancing T1 lesions will be evaluated using magnetic resonance imaging (MRI) technique. - Part B: Area Under the Curve Over the First 16 Weeks (AUC0-W16) of Ublituximab — Predose and at multiple timepoints up to Week 16
Trial sites (51)
| Facility | City | Region | Status |
|---|---|---|---|
| TG Therapeutics Investigational Trial Site | Birmingham | Alabama | Recruiting |
| TG Therapeutics Investigational Trial Site | Cullman | Alabama | Recruiting |
| TG Therapeutics Investigational Trial Site | Orange | California | Recruiting |
| TG Investigational Site | Fort Collins | Colorado | Recruiting |
| TG Therapeutics Investigational Trial Site | Washington D.C. | District of Columbia | Recruiting |
| TG Therapeutics Investigational Trial Site | Tampa | Florida | Recruiting |
| TG Therapeutics Investigational Trial Site | Atlanta | Georgia | Recruiting |
| TG Therapeutics Investigational Trial Site | Atlanta | Georgia | Recruiting |
| TG Therapeutics Investigational Trial Site | Savannah | Georgia | Recruiting |
| TG Therapeutics Investigational Trial Site | Chicago | Illinois | Recruiting |
| TG Therapeutics Investigational Trial Site | Indianapolis | Indiana | Recruiting |
| TG Therapeutics Investigational Trial Site | Iowa City | Iowa | Recruiting |
| TG Therapeutics Investigational Trial Site | Overland Park | Kansas | Recruiting |
| TG Therapeutics Investigational Trial Site | Overland Park | Kansas | Completed |
| TG Therapeutics Investigational Trial Site | Lutherville | Maryland | Recruiting |
| TG Therapeutics Investigational Trial Site | Boston | Massachusetts | Recruiting |
| TG Therapeutics Investigational Trial Site | Boston | Massachusetts | Recruiting |
| TG Therapeutics Investigational Trial Site | Foxborough | Massachusetts | Recruiting |
| TG Therapeutics Investigational Trial Site | North Worcester | Massachusetts | Recruiting |
| TG Therapeutics Investigational Trial Site | Wellesley | Massachusetts | Recruiting |
| TG Investigational Site | Farmington | Michigan | Recruiting |
| TG Therapeutics Investigational Trial Site | Golden Valley | Minnesota | Recruiting |
| TG Therapeutics Investigational Trial Site | Plymouth | Minnesota | Recruiting |
| TG Therapeutics Investigational Trial Site | St Louis | Missouri | Recruiting |
| TG Therapeutics Investigational Trial Site | New York | New York | Recruiting |
| TG Therapeutics Investigational Trial Site | New York | New York | Recruiting |
| TG Therapeutics Investigational Trial SiteCharlotte | Charlotte | North Carolina | Recruiting |
| TG Therapeutics Investigational Trial Site | Raleigh | North Carolina | Recruiting |
| TG Therapeutics Investigational Trial Site | Cincinnati | Ohio | Recruiting |
| TG Therapeutics Investigational Trial Site | Cleveland | Ohio | Recruiting |
| TG Therapeutics Investigational Trial Site | Dayton | Ohio | Recruiting |
| TG Therapeutics Investigational Trial Site | Oklahoma City | Oklahoma | Recruiting |
| TG Therapeutics Investigational Trial Site | Greenville | South Carolina | Recruiting |
| TG Therapeutics Investigational Trial Site | Knoxville | Tennessee | Recruiting |
| TG Therapeutics Investigational Trial Site | Houston | Texas | Completed |
| TG Therapeutics Investigational Trial Site | Salt Lake City | Utah | Recruiting |
| TG Therapeutics Investigational Trial Site | Vienna | Virginia | Recruiting |
| TG Therapeutics Investigational Trial Site | Kirkland | Washington | Recruiting |
| TG Therapeutics Investigational Trial Site | Seattle | Washington | Recruiting |
| TG Therapeutics Investigational Trial Site | Spokane | Washington | Recruiting |
+ 11 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05877963 on ClinicalTrials.gov ↗ ← All trials in the USA