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Clinical Trials in the USA / NCT04130997
Active, not recruiting Phase 3

An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

NCT04130997 · tracked via the Priya Life Science USA tracker
Sponsor
TG Therapeutics, Inc.
Phase
Phase 3
Started
2019-11-18
Last updated
2026-08-21

Condition(s) studied

Relapsing Multiple Sclerosis (RMS)

Investigational drug(s) / intervention(s)

Ublituximab

Ublituximab: Ublituximab (TG-1101) is a recombinant chimeric monoclonal antibody targeting CD20, available as a 25 mg/mL concentrate for intravenous use, supplied by TG Therapeutics, Inc.

Study summary

The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Participants must meet the following criteria: 1. 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 2. Investigator believes may benefit from treatment with ublituximab 3. Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol 4. 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 Exclusion Criteria: Participants who meet any of the following exclusion criteria are not to be enrolled to this study: 1. Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as: 1. Absolute neutrophil count \< 1.5 x 10e3/µL 2. Hematocrit \< 24% 3. Platelet count \< 150,000 cell/mm\^3 4. Hypogammaglobulinemia immunoglobulin G (IgG) \< 4.0g/L 2. Active infection 3. Ongoing pregnancy (female participants) 4. 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 5. 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 6. 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 7. Participants with unstable disease activity 8. Presence of malignancy, except for surgically excised basal or squamous cell skin lesions 9. Vaccination with live virus within 2 months of randomization

Primary outcome measure(s)

Trial sites (86)

FacilityCityRegionStatus
TG Therapeutics Investigational Trial Site Pasadena California
TG Therapeutics Investigational Trial Site Denver Colorado
TG Therapeutics Investigational Trial Site Miami Florida
TG Therapeutics Investigational Trial Site Tampa Florida
TG Therapeutics Investigational Trial Site Northbrook Illinois
TG Therapeutics Investigational Trial Site Kansas City Kansas
TG Therapeutics Investigational Trial Site Detroit Michigan
TG Therapeutics Investigational Trial Site Las Vegas Nevada
TG Therapeutics Investigational Trial Site Teaneck New Jersey
TG Therapeutics Investigational Trial Site Albuquerque New Mexico
TG Therapeutics Investigational Trial Site Amherst New York
TG Therapeutics Investigational Trial Site Columbus Ohio
TG Therapeutics Investigational Trial Site Westerville Ohio
TG Therapeutics Investigational Trial Site Knoxville Tennessee
TG Therapeutics Investigational Trial Site Dallas Texas
TG Therapeutics Investigational Trial Site Frisco Texas
TG Therapeutics Investigational Trial Site Round Rock Texas
TG Therapeutics Investigational Trial Site San Antonio Texas
TG Therapeutics Investigational Trial Site Seattle Washington
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 Varaždin Croatia
TG Investigational Trial Site Zagreb Croatia
TG Therapeutics Investigational Trial Site Tbilisi Georgia
TG Therapeutics Investigational Trial Site Tbilisi Georgia
TG Therapeutics Investigational Trial Site Tbilisi Georgia
TG Therapeutics Investigational Trial Site Tbilisi Georgia
TG Therapeutics Investigational Trial Site Tbilisi Georgia
TG Therapeutics Investigational Trial Site Tbilisi Georgia
TG Therapeutics Investigational Trial Site Katowice Poland
TG Therapeutics Investigational Trial Site Katowice Poland
TG Therapeutics Investigational Trial Site Katowice Poland
TG Therapeutics Investigational Trial Site Krakow Poland
TG Therapeutics Investigational Trial Site Lodz Poland
TG Therapeutics Investigational Trial Site Olsztyn Poland
TG Therapeutics Investigational Trial Site Poznan Poland

+ 46 more sites — see the full list on the official registry below.

More TG Therapeutics, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04130997 on ClinicalTrials.gov ↗ ← All trials in the USA