An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis (RMS) Clinical Trial

Official title:

An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04130997
• Other study ID #: TG1101-RMS303
• Secondary ID: 2019-003625-16
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 18, 2019
• Est. completion date: April 1, 2027

Study information

• Verified date: June 2024
• Source: TG Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1100
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis (RMS)
• Sclerosis

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Belarus	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
Croatia	TG Therapeutics Investigational Trial Site	Osijek
Croatia	TG Therapeutics Investigational Trial Site	Varazdin
Croatia	TG Investigational Trial Site	Zagreb
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	Tbilisi
Poland	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	Kraków
Poland	TG Therapeutics Investigational Trial Site	Lódz
Poland	TG Therapeutics Investigational Trial Site	Olsztyn
Poland	TG Therapeutics Investigational Trial Site	Poznan
Poland	TG Therapeutics Investigational Trial Site	Warszawa
Poland	TG Therapeutics Investigational Trial Site	Zabrze
Russian Federation	TG Therapeutics Investigational Trial Site	Arkhangel'sk
Russian Federation	TG Therapeutics Investigational Trial Site	Barnaul
Russian Federation	TG Therapeutics Investigational Trial Site	Bryansk
Russian Federation	TG Therapeutics Investigational Trial Site	Chelyabinsk
Russian Federation	TG Therapeutics Investigational Trial Site	Ekaterinburg
Russian Federation	TG Therapeutics Investigational Trial Site	Kemerovo
Russian Federation	TG Therapeutics Investigational Trial Site	Krasnoyarsk
Russian Federation	TG Therapeutics Investigational Trial Site	Kursk
Russian Federation	TG Therapeutics Investigational Trial Site	Moscow
Russian Federation	TG Therapeutics Investigational Trial Site	Moscow
Russian Federation	TG Therapeutics Investigational Trial Site	Nizhny Novgorod
Russian Federation	TG Therapeutics Investigational Trial Site	Novosibirsk
Russian Federation	TG Therapeutics Investigational Trial Site	Novosibirsk
Russian Federation	TG Therapeutics Investigational Trial Site	Pyatigorsk
Russian Federation	TG Therapeutics Investigational Trial Site	Saint Petersburg
Russian Federation	TG Therapeutics Investigational Trial Site	Saint Petersburg
Russian Federation	TG Therapeutics Investigational Trial Site	Saint Petersburg
Russian Federation	TG Therapeutics Investigational Trial Site	Saransk
Russian Federation	TG Therapeutics Investigational Trial Site	Smolensk
Russian Federation	TG Therapeutics Investigational Trial Site	Tomsk
Russian Federation	TG Therapeutics Investigational Trial Site	Tyumen
Russian Federation	TG Therapeutics Investigational Trial Site	Ufa
Serbia	TG Therapeutics Investigational Trial Site	Belgrade
Serbia	TG Therapeutics Investigational Trial Site	Kragujevac
Ukraine	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-Frankivs'k
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	Úzhgorod
Ukraine	TG Therapeutics Investigational Trial Site	Vinnytsya
Ukraine	TG Therapeutics Investigational Trial Site	Zaporizhia
Ukraine	TG Therapeutics Investigational Trial Site	Zaporizhia
Ukraine	TG Therapeutics Investigational Trial Site	Zhytomyr
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	Dallas	Texas
United States	TG Therapeutics Investigational Trial Site	Denver	Colorado
United States	TG Therapeutics Investigational Trial Site	Detroit	Michigan
United States	TG Therapeutics Investigational Trial Site	Frisco	Texas
United States	TG Therapeutics Investigational Trial Site	Kansas City	Kansas
United States	TG Therapeutics Investigational Trial Site	Knoxville	Tennessee
United States	TG Therapeutics Investigational Trial Site	Las Vegas	Nevada
United States	TG Therapeutics Investigational Trial Site	Miami	Florida
United States	TG Therapeutics Investigational Trial Site	Northbrook	Illinois
United States	TG Therapeutics Investigational Trial Site	Pasadena	California
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	Tampa	Florida
United States	TG Therapeutics Investigational Trial Site	Teaneck	New Jersey
United States	TG Therapeutics Investigational Trial Site	Westerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TG Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Belarus,  Croatia,  Georgia,  Poland,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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