Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
TG Therapeutics, Inc. · NCT05877963
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–65 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 800
- US sites recruiting
- 39
- Study start
- June 13, 2023
- Record last updated
- October 23, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Ublituximab; Placebo
Conditions: Relapsing Multiple Sclerosis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Diagnosis of RMS (2017 Revised McDonald criteria).
- Participants must meet one of the following prior treatment definitions:
- Participants naïve to treatment.
- 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.
Recruiting US locations
TG Therapeutics Investigational Trial Site
Birmingham, AL 35209
TG Therapeutics Investigational Trial Site
Cullman, AL 35058
TG Therapeutics Investigational Trial Site
Orange, CA 92697
TG Investigational Site
Fort Collins, CO 80528
TG Therapeutics Investigational Trial Site
Washington D.C., DC 20007
TG Therapeutics Investigational Trial Site
Tampa, FL 33612
TG Therapeutics Investigational Trial Site
Atlanta, GA 30309
TG Therapeutics Investigational Trial Site
Atlanta, GA 30322
TG Therapeutics Investigational Trial Site
Savannah, GA 31406
TG Therapeutics Investigational Trial Site
Chicago, IL 60612
TG Therapeutics Investigational Trial Site
Indianapolis, IN 46256
TG Therapeutics Investigational Trial Site
Iowa City, IA 52242
TG Therapeutics Investigational Trial Site
Overland Park, KS 66205
TG Therapeutics Investigational Trial Site
Lutherville, MD 21093
TG Therapeutics Investigational Trial Site
Boston, MA 00002
TG Therapeutics Investigational Trial Site
Boston, MA 70809
TG Therapeutics Investigational Trial Site
Foxborough, MA 02035
TG Therapeutics Investigational Trial Site
North Worcester, MA 01655
TG Therapeutics Investigational Trial Site
Wellesley, MA 02481
TG Investigational Site
Farmington, MI 48334
TG Therapeutics Investigational Trial Site
Golden Valley, MN 55422
TG Therapeutics Investigational Trial Site
Plymouth, MN 55446
TG Therapeutics Investigational Trial Site
St Louis, MO 63131
TG Therapeutics Investigational Trial Site
New York, NY 10025
TG Therapeutics Investigational Trial Site
New York, NY 11021
TG Therapeutics Investigational Trial SiteCharlotte
Charlotte, NC 28204
TG Therapeutics Investigational Trial Site
Raleigh, NC 27607
TG Therapeutics Investigational Trial Site
Cincinnati, OH 45212
TG Therapeutics Investigational Trial Site
Cleveland, OH 44195
TG Therapeutics Investigational Trial Site
Dayton, OH 45417
TG Therapeutics Investigational Trial Site
Oklahoma City, OK 73104
TG Therapeutics Investigational Trial Site
Greenville, SC 29605
TG Therapeutics Investigational Trial Site
Knoxville, TN 37922
TG Therapeutics Investigational Trial Site
Salt Lake City, UT 84103
TG Therapeutics Investigational Trial Site
Vienna, VA 22182
TG Therapeutics Investigational Trial Site
Kirkland, WA 98034
TG Therapeutics Investigational Trial Site
Seattle, WA 98109
TG Therapeutics Investigational Trial Site
Spokane, WA 99208
TG Therapeutics Investigational Trial Site
Milwaukee, WI 53226
Study contacts (from the official record)
- TG Therapeutics Clinical Support Team · 1-877-575-8489 · clinicalsupport@tgtxinc.com
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