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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003625-16 | EudraCT Number |
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The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).
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-blind treatment period of TG1101-RMS301 (RMS301 [NCT03277261]) or TG1101-RMS302 (RMS302 [NCT03277248]) are eligible for participation in this Open Label Extension (OLE) study. Participants may also be eligible for TG1101-RMS303 if they have completed Week 208 of TG1101-RMS201E (RMS201E [NCT03381170]) (United States of America [USA] participants only).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ublituximab Infusions | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ublituximab | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate (ARR) | ARR is defined as the number of relapses per-participant year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years). | Up to Week 336 |
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Inclusion Criteria:
Participants must meet the following criteria:
Exclusion Criteria:
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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TG Therapeutics Investigational Trial Site | Pasadena | California | 91105 | United States | ||
| TG Therapeutics Investigational Trial Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41697690 | Derived | Cree BAC, Fox E, Hartung HP, Alvarez E, Qian P, Wray S, Robertson D, Selmaj K, Wynn D, Mok K, Rowland C, Bodhinathan K, Sportelli P, Miskin HP, Steinman L. Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension Study. JAMA Neurol. 2026 Apr 1;83(4):348-358. doi: 10.1001/jamaneurol.2026.0007. |
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open-label, single-arm, extension study
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|
| Denver |
| Colorado |
| 80045 |
| United States |
| TG Therapeutics Investigational Trial Site | Miami | Florida | 33136 | United States |
| TG Therapeutics Investigational Trial Site | Tampa | Florida | 33612 | United States |
| TG Therapeutics Investigational Trial Site | Northbrook | Illinois | 60062 | United States |
| TG Therapeutics Investigational Trial Site | Kansas City | Kansas | 66160 | United States |
| TG Therapeutics Investigational Trial Site | Detroit | Michigan | 48201 | United States |
| TG Therapeutics Investigational Trial Site | Las Vegas | Nevada | 89106 | United States |
| TG Therapeutics Investigational Trial Site | Teaneck | New Jersey | 07666 | United States |
| TG Therapeutics Investigational Trial Site | Albuquerque | New Mexico | 87131 | United States |
| TG Therapeutics Investigational Trial Site | Amherst | New York | 14266 | United States |
| TG Therapeutics Investigational Trial Site | Columbus | Ohio | 43214 | United States |
| TG Therapeutics Investigational Trial Site | Westerville | Ohio | 43081 | United States |
| TG Therapeutics Investigational Trial Site | Knoxville | Tennessee | 37922 | United States |
| TG Therapeutics Investigational Trial Site | Dallas | Texas | 75246 | United States |
| TG Therapeutics Investigational Trial Site | Frisco | Texas | 75034 | United States |
| TG Therapeutics Investigational Trial Site | Round Rock | Texas | 78681 | United States |
| TG Therapeutics Investigational Trial Site | San Antonio | Texas | 78258 | United States |
| TG Therapeutics Investigational Trial Site | Seattle | Washington | 98109 | United States |
| TG Therapeutics Investigational Trial Site | Grodno | 230017 | Belarus |
| TG Therapeutics Investigational Trial Site | Grodno | 320017 | Belarus |
| TG Therapeutics Investigational Trial Site | Minsk | 220114 | Belarus |
| TG Therapeutics Investigational Trial Site | Minsk | 220116 | Belarus |
| TG Therapeutics Investigational Trial Site | Minsk | 220226 | Belarus |
| TG Therapeutics Investigational Trial Site | Osijek | 31000 | Croatia |
| TG Therapeutics Investigational Trial Site | Varaždin | 42000 | Croatia |
| TG Investigational Trial Site | Zagreb | 10000 | Croatia |
| TG Therapeutics Investigational Trial Site | Tbilisi | 00112 | Georgia |
| TG Therapeutics Investigational Trial Site | Tbilisi | 00114 | Georgia |
| TG Therapeutics Investigational Trial Site | Tbilisi | 00159 | Georgia |
| TG Therapeutics Investigational Trial Site | Tbilisi | 00160 | Georgia |
| TG Therapeutics Investigational Trial Site | Tbilisi | 00172 | Georgia |
| TG Therapeutics Investigational Trial Site | Tbilisi | 00179 | Georgia |
| TG Therapeutics Investigational Trial Site | Katowice | 40-555 | Poland |
| TG Therapeutics Investigational Trial Site | Katowice | 40-568 | Poland |
| TG Therapeutics Investigational Trial Site | Katowice | 40-684 | Poland |
| TG Therapeutics Investigational Trial Site | Krakow | 31-505 | Poland |
| TG Therapeutics Investigational Trial Site | Lodz | 41-800 | Poland |
| TG Therapeutics Investigational Trial Site | Olsztyn | 10-561 | Poland |
| TG Therapeutics Investigational Trial Site | Poznan | 61-583 | Poland |
| TG Therapeutics Investigational Trial Site | Warsaw | 04-141 | Poland |
| TG Therapeutics Investigational Trial Site | Zabrze | 04-749 | Poland |
| TG Therapeutics Investigational Trial Site | Arkhangelsk | 163045 | Russia |
| TG Therapeutics Investigational Trial Site | Barnaul | 656045 | Russia |
| TG Therapeutics Investigational Trial Site | Bryansk | 241033 | Russia |
| TG Therapeutics Investigational Trial Site | Chelyabinsk | 454021 | Russia |
| TG Therapeutics Investigational Trial Site | Kemerovo | 650066 | Russia |
| TG Therapeutics Investigational Trial Site | Krasnoyarsk | 660037 | Russia |
| TG Therapeutics Investigational Trial Site | Kursk | 305007 | Russia |
| TG Therapeutics Investigational Trial Site | Moscow | 125367 | Russia |
| TG Therapeutics Investigational Trial Site | Moscow | 127015 | Russia |
| TG Therapeutics Investigational Trial Site | Nizhny Novgorod | 603155 | Russia |
| TG Therapeutics Investigational Trial Site | Novosibirsk | 630007 | Russia |
| TG Therapeutics Investigational Trial Site | Novosibirsk | 630087 | Russia |
| TG Therapeutics Investigational Trial Site | Pyatigorsk | 357538 | Russia |
| TG Therapeutics Investigational Trial Site | Saint Petersburg | 197002 | Russia |
| TG Therapeutics Investigational Trial Site | Saint Petersburg | 197110 | Russia |
| TG Therapeutics Investigational Trial Site | Saint Petersburg | 197376 | Russia |
| TG Therapeutics Investigational Trial Site | Saransk | 430032 | Russia |
| TG Therapeutics Investigational Trial Site | Smolensk | 214018 | Russia |
| TG Therapeutics Investigational Trial Site | Tomsk | 634050 | Russia |
| TG Therapeutics Investigational Trial Site | Tyumen | 625000 | Russia |
| TG Therapeutics Investigational Trial Site | Ufa | 450005 | Russia |
| TG Therapeutics Investigational Trial Site | Yekaterinburg | 620102 | Russia |
| TG Therapeutics Investigational Trial Site | Belgrade | 11000 | Serbia |
| TG Therapeutics Investigational Trial Site | Kragujevac | 34000 | Serbia |
| TG Therapeutics Investigational Trial Site | Cherkasy | 18009 | Ukraine |
| TG Therapeutics Investigational Trial Site | Chernihiv | 14001 | Ukraine |
| TG Therapeutics Investigational Trial Site | Chernihiv | 14029 | Ukraine |
| TG Therapeutics Investigational Trial Site | Chernivtsi | 58002 | Ukraine |
| TG Therapeutics Investigational Trial Site | Ivano-Frankivsk | 76008 | Ukraine |
| TG Therapeutics Investigational Trial Site | Kharkiv | 61058 | Ukraine |
| TG Therapeutics Investigational Trial Site | Kharkiv | 61103 | Ukraine |
| TG Therapeutics Investigational Trial Site | Kharkiv | 61176 | Ukraine |
| TG Therapeutics Investigational Trial Site | Kyiv | 03037 | Ukraine |
| TG Therapeutics Investigational Trial Site | Kyiv | 03115 | Ukraine |
| TG Therapeutics Investigational Trial Site | Lviv | 79000 | Ukraine |
| TG Therapeutics Investigational Trial Site | Lviv | 79010 | Ukraine |
| TG Therapeutics Investigational Trial Site | Odesa | 65009 | Ukraine |
| TG Therapeutics Investigational Trial Site | Poltava | 36011 | Ukraine |
| TG Therapeutics Investigational Trial Site | Ternopil | 46027 | Ukraine |
| TG Therapeutics Investigational Trial Site | Uzhhorod | 88018 | Ukraine |
| TG Therapeutics Investigational Trial Site | Vinnytsia | 21005 | Ukraine |
| TG Therapeutics Investigational Trial Site | Zaporizhia | 69065 | Ukraine |
| TG Therapeutics Investigational Trial Site | Zaporizhia | 96900 | Ukraine |
| TG Therapeutics Investigational Trial Site | Zhytomyr | 10002 | Ukraine |
| ID | Term |
|---|---|
| C000619007 | ublituximab |
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