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Evaluating a modified treatment regimen of ublituximab for relapsing multiple sclerosis

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

PHASE3 · TG Therapeutics, Inc. · NCT05877963

This study is testing a new way to use ublituximab to see if it can help people with relapsing multiple sclerosis feel better and stay safe.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment800 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorTG Therapeutics, Inc. (industry)
Drugs / interventionsublituximab, alemtuzumab, daclizumab, cyclophosphamide
Locations46 sites (Birmingham, Alabama and 45 other locations)
Trial IDNCT05877963 on ClinicalTrials.gov

What this trial studies

This phase 3b clinical trial aims to assess the safety and efficacy of a modified regimen of ublituximab in patients with relapsing multiple sclerosis (RMS). The study is divided into two parts: Part A is a single-arm, open-label segment, while Part B is a randomized, double-blind, placebo-controlled segment. The primary outcome measures include the evaluation of T1 Gadolinium-enhancing lesions and pharmacokinetics of the treatment. Participants will be monitored for their response to the modified treatment regimen over the course of the study.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with relapsing multiple sclerosis who are either treatment-naïve or have previously discontinued disease-modifying therapy.

Not a fit: Patients with primary-progressive multiple sclerosis or those with a history of serious infusion-related reactions to anti-CD20 therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with relapsing multiple sclerosis.

How similar studies have performed: Other studies have shown success with similar approaches in treating relapsing multiple sclerosis, indicating a promising avenue for this modified regimen.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.
* Part C: participants currently treated with an anti-CD20 agent for at least 6 months and meet the washout requirements prior to W1D1.
* Part C: Discontinuation of current anti-CD20 must be due to suboptimal experience

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 than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).
* Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment such as, but not limited to chronic urinary tract infection, chronic pulmonary infection with bronchiectasis, tuberculosis, or active hepatitis C virus (HCV).
* Previous serious opportunistic or atypical infection.
* Evidence of chronic active or history of hepatitis B virus (HBV) infection as evidenced by a detectable hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb), or chronic hepatitis C infection. Participants with positive hepatitis C virus antibody (HCV Ab) are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
* History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML).
* Receipt of any live or live-attenuated vaccines (including vaccines for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration.
* Participants requiring treatment with intravenous immune globulin (IVIG) for decreased immunoglobulins within the 12 months prior to W1D1.
* Any active malignancies other than adequately treated basal, squamous cell or in situ carcinoma.
* Participants who have ever received ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab (including for non-MS indications).

Note: Other Inclusion/Exclusion criteria may apply.

Where this trial is running

Birmingham, Alabama and 45 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Relapsing Multiple Sclerosis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.