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Recruiting Phase 3 Interventional

Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab

ClinicalTrials.gov ID: NCT05877963

Public ClinicalTrials.gov record NCT05877963. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 7:59 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluating Safety, Efficacy and Pharmacokinetics of a Modified Regimen of Ublituximab (ENHANCE )

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05877963
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
TG Therapeutics, Inc.
Industry
Enrollment
800 participants

Conditions and interventions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 12, 2023
Primary completion
Jan 20, 2027
Completion
Jan 20, 2027
Last update posted
Aug 26, 2026

2023 – 2027

United States locations

U.S. sites
41
U.S. states
26
U.S. cities
37
Facility City State ZIP Site status
TG Therapeutics Investigational Trial Site Birmingham Alabama 35209 Recruiting
TG Therapeutics Investigational Trial Site Cullman Alabama 35058 Recruiting
TG Therapeutics Investigational Trial Site Orange California 92697 Recruiting
TG Investigational Site Fort Collins Colorado 80528 Recruiting
TG Therapeutics Investigational Trial Site Washington D.C. District of Columbia 20007 Recruiting
TG Therapeutics Investigational Trial Site Tampa Florida 33612 Recruiting
TG Therapeutics Investigational Trial Site Atlanta Georgia 30309 Recruiting
TG Therapeutics Investigational Trial Site Atlanta Georgia 30322 Recruiting
TG Therapeutics Investigational Trial Site Savannah Georgia 31406 Recruiting
TG Therapeutics Investigational Trial Site Chicago Illinois 60612 Recruiting
TG Therapeutics Investigational Trial Site Indianapolis Indiana 46256 Recruiting
TG Therapeutics Investigational Trial Site Iowa City Iowa 52242 Recruiting
TG Therapeutics Investigational Trial Site Overland Park Kansas 66205 Recruiting
TG Therapeutics Investigational Trial Site Overland Park Kansas 66212 Completed
TG Therapeutics Investigational Trial Site Lutherville Maryland 21093 Recruiting
TG Therapeutics Investigational Trial Site Boston Massachusetts 00002 Recruiting
TG Therapeutics Investigational Trial Site Boston Massachusetts 70809 Recruiting
TG Therapeutics Investigational Trial Site Foxborough Massachusetts 02035 Recruiting
TG Therapeutics Investigational Trial Site North Worcester Massachusetts 01655 Recruiting
TG Therapeutics Investigational Trial Site Wellesley Massachusetts 02481 Recruiting
TG Investigational Site Farmington Michigan 48334 Recruiting
TG Therapeutics Investigational Trial Site Golden Valley Minnesota 55422 Recruiting
TG Therapeutics Investigational Trial Site Plymouth Minnesota 55446 Recruiting
TG Therapeutics Investigational Trial Site St Louis Missouri 63131 Recruiting
TG Therapeutics Investigational Trial Site New York New York 10025 Recruiting
TG Therapeutics Investigational Trial Site New York New York 11021 Recruiting
TG Therapeutics Investigational Trial SiteCharlotte Charlotte North Carolina 28204 Recruiting
TG Therapeutics Investigational Trial Site Raleigh North Carolina 27607 Recruiting
TG Therapeutics Investigational Trial Site Cincinnati Ohio 45212 Recruiting
TG Therapeutics Investigational Trial Site Cleveland Ohio 44195 Recruiting
TG Therapeutics Investigational Trial Site Dayton Ohio 45417 Recruiting
TG Therapeutics Investigational Trial Site Oklahoma City Oklahoma 73104 Recruiting
TG Therapeutics Investigational Trial Site Greenville South Carolina 29605 Recruiting
TG Therapeutics Investigational Trial Site Knoxville Tennessee 37922 Recruiting
TG Therapeutics Investigational Trial Site Houston Texas 77030 Completed
TG Therapeutics Investigational Trial Site Salt Lake City Utah 84103 Recruiting
TG Therapeutics Investigational Trial Site Vienna Virginia 22182 Recruiting
TG Therapeutics Investigational Trial Site Kirkland Washington 98034 Recruiting
TG Therapeutics Investigational Trial Site Seattle Washington 98109 Recruiting
TG Therapeutics Investigational Trial Site Spokane Washington 99208 Recruiting
TG Therapeutics Investigational Trial Site Milwaukee Wisconsin 53226 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05877963, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 26, 2026 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05877963 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →