Multiple Sclerosis Clinical Trial

Study to Evaluate Efficacy When Transitioning From a Current Disease Modifying Therapy (DMT) to Ublituximab

Summary

The primary purpose of this phase 3b study is to assess the maintenance of efficacy after transition from current anti-CD20 therapy to ublituximab, as measured by T1 Gadolinium (Gd)-enhancing lesions.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of RMS (2017 Revised McDonald criteria).
Participants currently treated with ocrelizumab, rituximab, ofatumumab.
Participants that are currently being treated with other selected DMTs.
Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
Neurologically stable for > 30 days prior to first dose of ublituximab.

Exclusion Criteria:

Suboptimal response to anti-CD20 therapy in the prior 6 months defined as

Documented MRI worsening (≥ 2 active T1-weighted Gd-enhancing lesions, any new or enlarging T2 lesions and/or
Clinical worsening as measured by EDSS or meaningful change in clinical measure
Relapse within the 12 months prior to W1D1.
History of any Grade > 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).

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT05877963

Recruitment Status:

Recruiting

Sponsor:

TG Therapeutics, Inc.

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There are 21 Locations for this study

See Locations Near You

TG Therapeutics Investigational Trial Site
Birmingham Alabama, 35209, United States
TG Therapeutics Investigational Trial Site
Cullman Alabama, 35058, United States
TG Investigational Site
Fort Collins Colorado, 80528, United States
TG Therapeutics Investigational Trial Site
Tampa Florida, 33612, United States
TG Therapeutics Investigational Trial Site
Indianapolis Indiana, 46256, United States
TG Therapeutics Investigational Trial Site
Lutherville Maryland, 21093, United States
TG Therapeutics Investigational Trial Site
Boston Massachusetts, 70809, United States
TG Therapeutics Investigational Trial Site
Foxboro Massachusetts, 02035, United States
TG Investigational Site
Farmington Michigan, 48334, United States
TG Therapeutics Investigational Trial Site
Golden Valley Minnesota, 55422, United States
TG Therapeutics Investigational Trial Site
Plymouth Minnesota, 55446, United States
TG Therapeutics Investigational Trial Site
Saint Louis Missouri, 63131, United States
TG Therapeutics Investigational Trial Site
New York New York, 10025, United States
TG Therapeutics Investigational Trial Site
New York New York, 11021, United States
TG Therapeutics Investigational Trial Site
Raleigh North Carolina, 27607, United States
TG Therapeutics Investigational Trial Site
Oklahoma City Oklahoma, 73104, United States
TG Therapeutics Investigational Trial Site
Knoxville Tennessee, 37922, United States
TG Therapeutics Investigational Trial Site
Salt Lake City Utah, 84103, United States
TG Therapeutics Investigational Trial Site
Vienna Virginia, 22182, United States
TG Therapeutics Investigational Trial Site
Kirkland Washington, 98034, United States
TG Therapeutics Investigational Trial Site
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT05877963

Recruitment Status:

Recruiting

Sponsor:


TG Therapeutics, Inc.

How clear is this clinincal trial information?

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