An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
NCT ID: NCT04130997
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1100 participants
INTERVENTIONAL
2019-11-18
2030-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ublituximab Infusions
RMS301/RMS302: All participants transferring from RMS301/RMS302 who sign consent for this study will receive an initial 4-hour infusion of 150 mg ublituximab on Week 1 (Day 1) followed by a 1-hour infusion of 450 mg ublituximab 14 days later Week 3 (Day 15). Subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312.
RMS201E: All participants transferring from RMS201E who sign consent for this study will receive a 1-hour infusion of 450 mg ublituximab on Week 1 (Day 1) and subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312.
For all participants (RMS301/RMS302/RMS201E), infusion treatment will continue for 312 weeks, or until physician or participant decision to withdraw from the study.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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
18 Years
ALL
No
Sponsors
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TG Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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TG Therapeutics Investigational Trial Site
Pasadena, California, United States
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
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
TG Therapeutics Investigational Trial Site
Warsaw, , Poland
TG Therapeutics Investigational Trial Site
Zabrze, , Poland
TG Therapeutics Investigational Trial Site
Arkhangelsk, , Russia
TG Therapeutics Investigational Trial Site
Barnaul, , Russia
TG Therapeutics Investigational Trial Site
Bryansk, , Russia
TG Therapeutics Investigational Trial Site
Chelyabinsk, , Russia
TG Therapeutics Investigational Trial Site
Kemerovo, , Russia
TG Therapeutics Investigational Trial Site
Krasnoyarsk, , Russia
TG Therapeutics Investigational Trial Site
Kursk, , Russia
TG Therapeutics Investigational Trial Site
Moscow, , Russia
TG Therapeutics Investigational Trial Site
Moscow, , Russia
TG Therapeutics Investigational Trial Site
Nizhny Novgorod, , Russia
TG Therapeutics Investigational Trial Site
Novosibirsk, , Russia
TG Therapeutics Investigational Trial Site
Novosibirsk, , Russia
TG Therapeutics Investigational Trial Site
Pyatigorsk, , Russia
TG Therapeutics Investigational Trial Site
Saint Petersburg, , Russia
TG Therapeutics Investigational Trial Site
Saint Petersburg, , Russia
TG Therapeutics Investigational Trial Site
Saint Petersburg, , Russia
TG Therapeutics Investigational Trial Site
Saransk, , Russia
TG Therapeutics Investigational Trial Site
Smolensk, , Russia
TG Therapeutics Investigational Trial Site
Tomsk, , Russia
TG Therapeutics Investigational Trial Site
Tyumen, , Russia
TG Therapeutics Investigational Trial Site
Ufa, , Russia
TG Therapeutics Investigational Trial Site
Yekaterinburg, , Russia
TG Therapeutics Investigational Trial Site
Belgrade, , Serbia
TG Therapeutics Investigational Trial Site
Kragujevac, , Serbia
TG Therapeutics Investigational Trial Site
Cherkasy, , Ukraine
TG Therapeutics Investigational Trial Site
Chernihiv, , Ukraine
TG Therapeutics Investigational Trial Site
Chernihiv, , Ukraine
TG Therapeutics Investigational Trial Site
Chernivtsi, , Ukraine
TG Therapeutics Investigational Trial Site
Ivano-Frankivsk, , Ukraine
TG Therapeutics Investigational Trial Site
Kharkiv, , Ukraine
TG Therapeutics Investigational Trial Site
Kharkiv, , Ukraine
TG Therapeutics Investigational Trial Site
Kharkiv, , Ukraine
TG Therapeutics Investigational Trial Site
Kyiv, , Ukraine
TG Therapeutics Investigational Trial Site
Kyiv, , Ukraine
TG Therapeutics Investigational Trial Site
Lviv, , Ukraine
TG Therapeutics Investigational Trial Site
Lviv, , Ukraine
TG Therapeutics Investigational Trial Site
Odesa, , Ukraine
TG Therapeutics Investigational Trial Site
Poltava, , Ukraine
TG Therapeutics Investigational Trial Site
Ternopil, , Ukraine
TG Therapeutics Investigational Trial Site
Uzhhorod, , Ukraine
TG Therapeutics Investigational Trial Site
Vinnytsia, , Ukraine
TG Therapeutics Investigational Trial Site
Zaporizhia, , Ukraine
TG Therapeutics Investigational Trial Site
Zaporizhia, , Ukraine
TG Therapeutics Investigational Trial Site
Zhytomyr, , Ukraine
Countries
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Other Identifiers
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2019-003625-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TG1101-RMS303
Identifier Type: -
Identifier Source: org_study_id