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).

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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).

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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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1100

Study ID:

NCT04130997

Recruitment Status:

Active, not recruiting

Sponsor:

TG Therapeutics, Inc.

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There are 85 Locations for this study

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TG Therapeutics Investigational Trial Site
Pasadena California, 91105, United States
TG Therapeutics Investigational Trial Site
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
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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 , 23001, Belarus
TG Therapeutics Investigational Trial Site
Grodno , 32001, Belarus
TG Therapeutics Investigational Trial Site
Minsk , 22011, Belarus
TG Therapeutics Investigational Trial Site
Minsk , 22011, Belarus
TG Therapeutics Investigational Trial Site
Minsk , 22022, Belarus
TG Therapeutics Investigational Trial Site
Osijek , 31000, Croatia
TG Therapeutics Investigational Trial Site
Varazdin , 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 , 40-55, Poland
TG Therapeutics Investigational Trial Site
Katowice , 40-56, Poland
TG Therapeutics Investigational Trial Site
Katowice , 40-68, Poland
TG Therapeutics Investigational Trial Site
Kraków , 31-50, Poland
TG Therapeutics Investigational Trial Site
Olsztyn , 10-56, Poland
TG Therapeutics Investigational Trial Site
Poznań , 61-58, Poland
TG Therapeutics Investigational Trial Site
Warszawa , 04-14, Poland
TG Therapeutics Investigational Trial Site
Zabrze , 04-74, Poland
TG Therapeutics Investigational Trial Site
Łódź , 41-80, Poland
TG Therapeutics Investigational Trial Site
Arkhangel'sk , 16304, Russian Federation
TG Therapeutics Investigational Trial Site
Barnaul , 65604, Russian Federation
TG Therapeutics Investigational Trial Site
Bryansk , 24103, Russian Federation
TG Therapeutics Investigational Trial Site
Chelyabinsk , 45402, Russian Federation
TG Therapeutics Investigational Trial Site
Ekaterinburg , 62010, Russian Federation
TG Therapeutics Investigational Trial Site
Kemerovo , 65006, Russian Federation
TG Therapeutics Investigational Trial Site
Krasnoyarsk , 66003, Russian Federation
TG Therapeutics Investigational Trial Site
Kursk , 30500, Russian Federation
TG Therapeutics Investigational Trial Site
Moscow , 12536, Russian Federation
TG Therapeutics Investigational Trial Site
Moscow , 12701, Russian Federation
TG Therapeutics Investigational Trial Site
Nizhny Novgorod , 60315, Russian Federation
TG Therapeutics Investigational Trial Site
Novosibirsk , 63000, Russian Federation
TG Therapeutics Investigational Trial Site
Novosibirsk , 63008, Russian Federation
TG Therapeutics Investigational Trial Site
Pyatigorsk , 35753, Russian Federation
TG Therapeutics Investigational Trial Site
Saint Petersburg , 19700, Russian Federation
TG Therapeutics Investigational Trial Site
Saint Petersburg , 19711, Russian Federation
TG Therapeutics Investigational Trial Site
Saint Petersburg , 19737, Russian Federation
TG Therapeutics Investigational Trial Site
Saransk , 43003, Russian Federation
TG Therapeutics Investigational Trial Site
Smolensk , 21401, Russian Federation
TG Therapeutics Investigational Trial Site
Tomsk , 63405, Russian Federation
TG Therapeutics Investigational Trial Site
Tyumen , 62500, Russian Federation
TG Therapeutics Investigational Trial Site
Ufa , 45000, Russian Federation
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-Frankivs'k , 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
Vinnytsya , 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
TG Therapeutics Investigational Trial Site
Úzhgorod , 88018, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1100

Study ID:

NCT04130997

Recruitment Status:

Active, not recruiting

Sponsor:


TG Therapeutics, Inc.

How clear is this clinincal trial information?

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