Dysautonomia International

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

Purpose

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.

Condition

Relapsing Multiple Sclerosis

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Part A: Ublituximab	Participants will receive a modified regimen of ublituximab including infusions on Day 1 of Week 1 (W1D1), Day 15, if applicable, and ublituximab 450 milligrams (mg) infusion at Week 24. With Protocol Version 6.0, enrollment in Part A was closed.	Biological: Ublituximab Administered as an intravenous (IV) infusion. Other names: TG-1101 BRIUMVI
Experimental Part B: Ublituximab /Placebo (Treatment Arm A)	Participants will receive 600 mg of ublituximab on W1D1 followed by a placebo infusion on Day 15 and 450 mg ublituximab infusion at Week 24. With Protocol Version 7.0, enrollment in Part B will be closed.	Biological: Ublituximab Administered as an intravenous (IV) infusion. Other names: TG-1101 BRIUMVI Drug: Placebo IV infusion
Experimental Part B: Ublituximab (Treatment Arm B)	Participants will receive 150 mg of ublituximab on W1D1 followed by 450 mg on Day 15 and at Week 24. With Protocol Version 7.0, enrollment in Part B will be closed.	Biological: Ublituximab Administered as an intravenous (IV) infusion. Other names: TG-1101 BRIUMVI
Experimental Part C: Ublituximab (Treatment Arm C)	Participants will receive 150 mg of ublituximab on W1D1, followed by 450 mg on Day 15 and at Week 24.	Biological: Ublituximab Administered as an intravenous (IV) infusion. Other names: TG-1101 BRIUMVI

Recruiting Locations

TG Therapeutics Investigational Trial Site
Birmingham, Alabama 35209

TG Therapeutics Investigational Trial Site
Cullman, Alabama 35058

TG Therapeutics Investigational Trial Site
Orange, California 92697

TG Investigational Site
Fort Collins, Colorado 80528

TG Therapeutics Investigational Trial Site
Washington D.C., District of Columbia 20007

TG Therapeutics Investigational Trial Site
Tampa, Florida 33612

TG Therapeutics Investigational Trial Site
Chicago, Illinois 60612

TG Therapeutics Investigational Trial Site
Indianapolis, Indiana 46256

TG Therapeutics Investigational Trial Site
Iowa City, Iowa 52242

TG Therapeutics Investigational Trial Site
Overland Park, Kansas 66212

TG Therapeutics Investigational Trial Site
Lutherville, Maryland 21093

TG Therapeutics Investigational Trial Site
Boston, Massachusetts 00002

TG Therapeutics Investigational Trial Site
Foxborough, Massachusetts 02035

TG Therapeutics Investigational Trial Site
North Worcester, Massachusetts 01655

TG Therapeutics Investigational Trial Site
Wellesley, Massachusetts 02481uni

TG Investigational Site
Farmington, Michigan 48334

TG Therapeutics Investigational Trial Site
Golden Valley, Minnesota 55422

TG Therapeutics Investigational Trial Site
Plymouth, Minnesota 55446

TG Therapeutics Investigational Trial Site
St Louis, Missouri 63131

TG Therapeutics Investigational Trial Site
New York, New York 10025

TG Therapeutics Investigational Trial Site
New York, New York 11021

TG Therapeutics Investigational Trial SiteCharlotte
Charlotte, North Carolina 28204

TG Therapeutics Investigational Trial Site
Raleigh, North Carolina 27607

TG Therapeutics Investigational Trial Site
Cleveland, Ohio 44195

TG Therapeutics Investigational Trial Site
Dayton, Ohio 45417

TG Therapeutics Investigational Trial Site
Oklahoma City, Oklahoma 73104

TG Therapeutics Investigational Trial Site
Greenville, South Carolina 29605

TG Therapeutics Investigational Trial Site
Knoxville, Tennessee 37922

TG Therapeutics Investigational Trial Site
Salt Lake City, Utah 84103

TG Therapeutics Investigational Trial Site
Vienna, Virginia 22182

TG Therapeutics Investigational Trial Site
Kirkland, Washington 98034

TG Therapeutics Investigational Trial Site
Seattle, Washington 98109

TG Therapeutics Investigational Trial Site
Spokane, Washington 99208

TG Therapeutics Investigational Trial Site
Milwaukee, Wisconsin 53226

More Details

Status: Recruiting
Sponsor: TG Therapeutics, Inc.

Study Contact

TG Therapeutics Clinical Support Team
1-877-575-8489
clinicalsupport@tgtxinc.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.