An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Running, not enrolling · Phase 3
Conditions studied: Relapsing Multiple Sclerosis (RMS)
In brief
The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).
Key facts
- Study ID
- NCT04130997
- Run by
- TG Therapeutics, Inc.
- People needed
- 1100
- Starts
- 2019-11-18
- Expected to finish
- 2032-05-31
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants must meet the following criteria:
- Complete the 96-week double-blind TG1101-RMS301 (NCT03277261) or TG1101-RMS302 (NCT03277248) study or complete the final Week 208 visit of the TG1101-RMS201E (NCT03381170) study
- Investigator believes may benefit from treatment with ublituximab
- Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol
- Female participants of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 20 weeks after the last dose of ublituximab
You may not qualify if…
- Participants who meet any of the following exclusion criteria are not to be enrolled to this study:
- Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as:
- Absolute neutrophil count < 1.5 x 10e3/µL
- Hematocrit < 24%
- Platelet count < 150,000 cell/mm\^3
- Hypogammaglobulinemia immunoglobulin G (IgG) < 4.0g/L
- Active infection
- Ongoing pregnancy (female participants)
- Participants who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period or prior to completing the final Week 208 visit of the TG1101-RMS201E study
- Participants who have started any disease modifying therapy (DMT), stem cell transplantation, or participation in any other interventional clinical trial after completion of the 96-week visit in the TG1101-RMS301, TG1101-RMS302, or after completing the final Week 208 visit of the TG1101-RMS201E study
- Participants who have had a confirmed multiple sclerosis (MS) relapse within the past 30 days prior to Week 1 Day 1 (W1D1). Following a relapse, participants must be neurologically stable for at least 30 days prior to screening or W1D1 of the OLE
- Participants with unstable disease activity
- Presence of malignancy, except for surgically excised basal or squamous cell skin lesions
- Vaccination with live virus within 2 months of randomization
Where it is running
- TG Therapeutics Investigational Trial Site — Denver, Colorado, United States
- TG Therapeutics Investigational Trial Site — Miami, Florida, United States
- TG Therapeutics Investigational Trial Site — Tampa, Florida, United States
- TG Therapeutics Investigational Trial Site — Northbrook, Illinois, United States
- TG Therapeutics Investigational Trial Site — Kansas City, Kansas, United States
- TG Therapeutics Investigational Trial Site — Detroit, Michigan, United States
- TG Therapeutics Investigational Trial Site — Las Vegas, Nevada, United States
- TG Therapeutics Investigational Trial Site — Teaneck, New Jersey, United States
- TG Therapeutics Investigational Trial Site — Albuquerque, New Mexico, United States
- TG Therapeutics Investigational Trial Site — Amherst, New York, United States
- TG Therapeutics Investigational Trial Site — Columbus, Ohio, United States
- TG Therapeutics Investigational Trial Site — Westerville, Ohio, United States
- TG Therapeutics Investigational Trial Site — Knoxville, Tennessee, United States
- TG Therapeutics Investigational Trial Site — Dallas, Texas, United States
- TG Therapeutics Investigational Trial Site — Frisco, Texas, United States
- TG Therapeutics Investigational Trial Site — Round Rock, Texas, United States
- TG Therapeutics Investigational Trial Site — San Antonio, Texas, United States
- TG Therapeutics Investigational Trial Site — Seattle, Washington, United States
- TG Therapeutics Investigational Trial Site — Grodno, Belarus
- TG Therapeutics Investigational Trial Site — Grodno, Belarus
- TG Therapeutics Investigational Trial Site — Minsk, Belarus
- TG Therapeutics Investigational Trial Site — Minsk, Belarus
- TG Therapeutics Investigational Trial Site — Minsk, Belarus
- TG Therapeutics Investigational Trial Site — Osijek, Croatia
- TG Therapeutics Investigational Trial Site — Pasadena, California, United States
Full record on ClinicalTrials.gov
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