Status:
ACTIVE_NOT_RECRUITING
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Lead Sponsor:
TG Therapeutics, Inc.
Conditions:
Relapsing Multiple Sclerosis (RMS)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).
Detailed Description
TG1101-RMS303 is an open-label, single-arm extension study designed to evaluate long-term safety and efficacy of ublituximab in participants with RMS. Participants who complete the 96-week, double-bli...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT04130997
Start Date
November 18 2019
End Date
February 1 2030
Last Update
December 30 2025
Active Locations (86)
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1
TG Therapeutics Investigational Trial Site
Pasadena, California, United States, 91105
2
TG Therapeutics Investigational Trial Site
Denver, Colorado, United States, 80045
3
TG Therapeutics Investigational Trial Site
Miami, Florida, United States, 33136
4
TG Therapeutics Investigational Trial Site
Tampa, Florida, United States, 33612