Clinical trial NCT04130997: An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Official title: An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis (RMS)
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-18
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label, single-arm, extension study
Primary purpose: TREATMENT

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-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:

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:

Participants who meet any of the following exclusion criteria are not to be enrolled to this study:

1. Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as:

   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

Primary outcomes:
measure: Annualized Relapse Rate (ARR)
timeFrame: Up to Week 336
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Denver
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Miami
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Tampa
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Northbrook
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Kansas City
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kansas
city: Detroit
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Michigan
city: Las Vegas
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Nevada
city: Teaneck
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: Albuquerque
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Mexico
city: Amherst
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: Columbus
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Westerville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Knoxville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Dallas
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Frisco
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Round Rock
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: San Antonio
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Seattle
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Grodno
country: Belarus
facility: TG Therapeutics Investigational Trial Site
city: Grodno
country: Belarus
facility: TG Therapeutics Investigational Trial Site
city: Minsk
country: Belarus
facility: TG Therapeutics Investigational Trial Site
city: Minsk
country: Belarus
facility: TG Therapeutics Investigational Trial Site
city: Minsk
country: Belarus
facility: TG Therapeutics Investigational Trial Site
city: Osijek
country: Croatia
facility: TG Therapeutics Investigational Trial Site
city: Varazdin
country: Croatia
facility: TG Therapeutics Investigational Trial Site
city: Zagreb
country: Croatia
facility: TG Investigational Trial Site
city: Tbilisi
country: Georgia
facility: TG Therapeutics Investigational Trial Site
city: Tbilisi
country: Georgia
facility: TG Therapeutics Investigational Trial Site
city: Tbilisi
country: Georgia
facility: TG Therapeutics Investigational Trial Site
city: Tbilisi
country: Georgia
facility: TG Therapeutics Investigational Trial Site
city: Tbilisi
country: Georgia
facility: TG Therapeutics Investigational Trial Site
city: Tbilisi
country: Georgia
facility: TG Therapeutics Investigational Trial Site
city: Katowice
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Katowice
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Katowice
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Kraków
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Olsztyn
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Poznań
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Warszawa
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Zabrze
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Łódź
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Arkhangel'sk
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Barnaul
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Bryansk
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Chelyabinsk
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Ekaterinburg
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Kemerovo
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Krasnoyarsk
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Kursk
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Moscow
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Moscow
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Nizhny Novgorod
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Novosibirsk
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Novosibirsk
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Pyatigorsk
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Saint Petersburg
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Saint Petersburg
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Saint Petersburg
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Saransk
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Smolensk
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Tomsk
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Tyumen
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Ufa
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Belgrade
country: Serbia
facility: TG Therapeutics Investigational Trial Site
city: Kragujevac
country: Serbia
facility: TG Therapeutics Investigational Trial Site
city: Cherkasy
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Chernihiv
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Chernihiv
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Chernivtsi
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Ivano-Frankivs'k
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Kharkiv
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Kharkiv
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Kharkiv
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Kyiv
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Kyiv
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Lviv
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Lviv
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Odesa
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Poltava
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Ternopil
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Vinnytsya
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Zaporizhia
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Zaporizhia
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Zhytomyr
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
city: Úzhgorod
country: Ukraine
facility: TG Therapeutics Investigational Trial Site
Study officials:
References: