NCT05877963 · TG Therapeutics, Inc.
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
(ENHANCE)
What this study is about
The primary purpose of this phase 3b study is to assess the effectiveness of a modified regimen of ublituximab as measured by T1 Gadolinium (Gd)-enhancing lesions and how the drug moves through the body in participants with Relapsing Multiple Sclerosis (RMS).
View original scientific description
The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab as measured by T1 Gadolinium (Gd)-enhancing lesions and pharmacokinetics in participants with Relapsing Multiple Sclerosis (RMS). The study consists of 2 parts: Part A is single-armed and open-label and Part B is randomized, double-blind, placebo-controlled.
Interventions
BIOLOGICAL
Ublituximab
Administered as an intravenous (IV) infusion.
DRUG
Placebo
IV infusion
Primary outcome measures
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
Time frame: 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
Time frame: Predose and at multiple timepoints up to Week 16
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of RMS (2017 Revised McDonald criteria).
- Participants must meet one of the following prior treatment definitions: 1. Participants naïve to treatment. 2. Participants previously treated with a disease modifying therapy (DMT) who have discontinued treatment prior to consent and meet the washout requirements.
- Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
- Neurologically stable for \> 30 days prior to first dose of ublituximab.
- Female participants of childbearing potential must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 6 months after the last dose of ublituximab.
Exclusion criteria
- History of any serious 3 Infusion Related Reaction (IRR) on prior anti-CD20 therapy.
- Primary-progressive multiple sclerosis (PPMS) or inactive Secondary Progressive MS (SPMS).
- Active chronic (or stable but treated with immune therapy) disease of the immune system other
Where
- Birmingham, Alabama
- Cullman, Alabama
- Orange, California
- Fort Collins, Colorado
- Washington D.C., District of Columbia
- Tampa, Florida
- Savannah, Georgia
- Chicago, Illinois
- Indianapolis, Indiana
- Iowa City, Iowa
- Overland Park, Kansas
- Lutherville, Maryland
And 23 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations