Multiple Sclerosis Clinical Trial
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Summary
The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).
Full 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-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).
Eligibility Criteria
Inclusion Criteria:
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 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:
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
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There are 85 Locations for this study
Pasadena California, 91105, United States
Denver Colorado, 80045, United States
Miami Florida, 33136, United States
Tampa Florida, 33612, United States
Northbrook Illinois, 60062, United States
Kansas City Kansas, 66160, United States
Detroit Michigan, 48201, United States
Las Vegas Nevada, 89106, United States
Teaneck New Jersey, 07666, United States
Albuquerque New Mexico, 87131, United States
Amherst New York, 14266, United States
Columbus Ohio, 43214, United States
Westerville Ohio, 43081, United States
Knoxville Tennessee, 37922, United States
Dallas Texas, 75246, United States
Frisco Texas, 75034, United States
Round Rock Texas, 78681, United States
San Antonio Texas, 78258, United States
Seattle Washington, 98109, United States
Grodno , 23001, Belarus
Grodno , 32001, Belarus
Minsk , 22011, Belarus
Minsk , 22011, Belarus
Minsk , 22022, Belarus
Osijek , 31000, Croatia
Varazdin , 42000, Croatia
Zagreb , 10000, Croatia
Tbilisi , 00112, Georgia
Tbilisi , 00114, Georgia
Tbilisi , 00159, Georgia
Tbilisi , 00160, Georgia
Tbilisi , 00172, Georgia
Tbilisi , 00179, Georgia
Katowice , 40-55, Poland
Katowice , 40-56, Poland
Katowice , 40-68, Poland
Kraków , 31-50, Poland
Olsztyn , 10-56, Poland
Poznań , 61-58, Poland
Warszawa , 04-14, Poland
Zabrze , 04-74, Poland
Åódź , 41-80, Poland
Arkhangel'sk , 16304, Russian Federation
Barnaul , 65604, Russian Federation
Bryansk , 24103, Russian Federation
Chelyabinsk , 45402, Russian Federation
Ekaterinburg , 62010, Russian Federation
Kemerovo , 65006, Russian Federation
Krasnoyarsk , 66003, Russian Federation
Kursk , 30500, Russian Federation
Moscow , 12536, Russian Federation
Moscow , 12701, Russian Federation
Nizhny Novgorod , 60315, Russian Federation
Novosibirsk , 63000, Russian Federation
Novosibirsk , 63008, Russian Federation
Pyatigorsk , 35753, Russian Federation
Saint Petersburg , 19700, Russian Federation
Saint Petersburg , 19711, Russian Federation
Saint Petersburg , 19737, Russian Federation
Saransk , 43003, Russian Federation
Smolensk , 21401, Russian Federation
Tomsk , 63405, Russian Federation
Tyumen , 62500, Russian Federation
Ufa , 45000, Russian Federation
Belgrade , 11000, Serbia
Kragujevac , 34000, Serbia
Cherkasy , 18009, Ukraine
Chernihiv , 14001, Ukraine
Chernihiv , 14029, Ukraine
Chernivtsi , 58002, Ukraine
Ivano-Frankivs'k , 76008, Ukraine
Kharkiv , 61058, Ukraine
Kharkiv , 61103, Ukraine
Kharkiv , 61176, Ukraine
Kyiv , 03037, Ukraine
Kyiv , 03115, Ukraine
Lviv , 79000, Ukraine
Lviv , 79010, Ukraine
Odesa , 65009, Ukraine
Poltava , 36011, Ukraine
Ternopil , 46027, Ukraine
Vinnytsya , 21005, Ukraine
Zaporizhia , 69065, Ukraine
Zaporizhia , 96900, Ukraine
Zhytomyr , 10002, Ukraine
Úzhgorod , 88018, Ukraine
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