An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

April 15, 2024 updated by: TG Therapeutics, Inc.

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

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

Study Overview

Status

Active, not recruiting

Conditions

Relapsing Multiple Sclerosis (RMS)

Intervention / Treatment

Biological: Ublituximab

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).

Study Type

Interventional

Enrollment (Actual)

1100

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belarus
- - Grodno, Belarus, 230017
    - TG Therapeutics Investigational Trial Site
  - Grodno, Belarus, 320017
    - TG Therapeutics Investigational Trial Site
  - Minsk, Belarus, 220114
    - TG Therapeutics Investigational Trial Site
  - Minsk, Belarus, 220116
    - TG Therapeutics Investigational Trial Site
  - Minsk, Belarus, 220226
    - TG Therapeutics Investigational Trial Site
Croatia
- - Osijek, Croatia, 31000
    - TG Therapeutics Investigational Trial Site
  - Varazdin, Croatia, 42000
    - TG Therapeutics Investigational Trial Site
  - Zagreb, Croatia, 10000
    - TG Investigational Trial Site
Georgia
- - Tbilisi, Georgia, 00112
    - TG Therapeutics Investigational Trial Site
  - Tbilisi, Georgia, 00114
    - TG Therapeutics Investigational Trial Site
  - Tbilisi, Georgia, 00159
    - TG Therapeutics Investigational Trial Site
  - Tbilisi, Georgia, 00160
    - TG Therapeutics Investigational Trial Site
  - Tbilisi, Georgia, 00172
    - TG Therapeutics Investigational Trial Site
  - Tbilisi, Georgia, 00179
    - TG Therapeutics Investigational Trial Site
Poland
- - Katowice, Poland, 40-555
    - TG Therapeutics Investigational Trial Site
  - Katowice, Poland, 40-568
    - TG Therapeutics Investigational Trial Site
  - Katowice, Poland, 40-684
    - TG Therapeutics Investigational Trial Site
  - Kraków, Poland, 31-505
    - TG Therapeutics Investigational Trial Site
  - Olsztyn, Poland, 10-561
    - TG Therapeutics Investigational Trial Site
  - Poznań, Poland, 61-583
    - TG Therapeutics Investigational Trial Site
  - Warszawa, Poland, 04-141
    - TG Therapeutics Investigational Trial Site
  - Zabrze, Poland, 04-749
    - TG Therapeutics Investigational Trial Site
  - Łódź, Poland, 41-800
    - TG Therapeutics Investigational Trial Site
Russian Federation
- - Arkhangel'sk, Russian Federation, 163045
    - TG Therapeutics Investigational Trial Site
  - Barnaul, Russian Federation, 656045
    - TG Therapeutics Investigational Trial Site
  - Bryansk, Russian Federation, 241033
    - TG Therapeutics Investigational Trial Site
  - Chelyabinsk, Russian Federation, 454021
    - TG Therapeutics Investigational Trial Site
  - Ekaterinburg, Russian Federation, 620102
    - TG Therapeutics Investigational Trial Site
  - Kemerovo, Russian Federation, 650066
    - TG Therapeutics Investigational Trial Site
  - Krasnoyarsk, Russian Federation, 660037
    - TG Therapeutics Investigational Trial Site
  - Kursk, Russian Federation, 305007
    - TG Therapeutics Investigational Trial Site
  - Moscow, Russian Federation, 125367
    - TG Therapeutics Investigational Trial Site
  - Moscow, Russian Federation, 127015
    - TG Therapeutics Investigational Trial Site
  - Nizhny Novgorod, Russian Federation, 603155
    - TG Therapeutics Investigational Trial Site
  - Novosibirsk, Russian Federation, 630007
    - TG Therapeutics Investigational Trial Site
  - Novosibirsk, Russian Federation, 630087
    - TG Therapeutics Investigational Trial Site
  - Pyatigorsk, Russian Federation, 357538
    - TG Therapeutics Investigational Trial Site
  - Saint Petersburg, Russian Federation, 197002
    - TG Therapeutics Investigational Trial Site
  - Saint Petersburg, Russian Federation, 197110
    - TG Therapeutics Investigational Trial Site
  - Saint Petersburg, Russian Federation, 197376
    - TG Therapeutics Investigational Trial Site
  - Saransk, Russian Federation, 430032
    - TG Therapeutics Investigational Trial Site
  - Smolensk, Russian Federation, 214018
    - TG Therapeutics Investigational Trial Site
  - Tomsk, Russian Federation, 634050
    - TG Therapeutics Investigational Trial Site
  - Tyumen, Russian Federation, 625000
    - TG Therapeutics Investigational Trial Site
  - Ufa, Russian Federation, 450005
    - TG Therapeutics Investigational Trial Site
Serbia
- - Belgrade, Serbia, 11000
    - TG Therapeutics Investigational Trial Site
  - Kragujevac, Serbia, 34000
    - TG Therapeutics Investigational Trial Site
Ukraine
- - Cherkasy, Ukraine, 18009
    - TG Therapeutics Investigational Trial Site
  - Chernihiv, Ukraine, 14001
    - TG Therapeutics Investigational Trial Site
  - Chernihiv, Ukraine, 14029
    - TG Therapeutics Investigational Trial Site
  - Chernivtsi, Ukraine, 58002
    - TG Therapeutics Investigational Trial Site
  - Ivano-Frankivs'k, Ukraine, 76008
    - TG Therapeutics Investigational Trial Site
  - Kharkiv, Ukraine, 61058
    - TG Therapeutics Investigational Trial Site
  - Kharkiv, Ukraine, 61103
    - TG Therapeutics Investigational Trial Site
  - Kharkiv, Ukraine, 61176
    - TG Therapeutics Investigational Trial Site
  - Kyiv, Ukraine, 03037
    - TG Therapeutics Investigational Trial Site
  - Kyiv, Ukraine, 03115
    - TG Therapeutics Investigational Trial Site
  - Lviv, Ukraine, 79000
    - TG Therapeutics Investigational Trial Site
  - Lviv, Ukraine, 79010
    - TG Therapeutics Investigational Trial Site
  - Odesa, Ukraine, 65009
    - TG Therapeutics Investigational Trial Site
  - Poltava, Ukraine, 36011
    - TG Therapeutics Investigational Trial Site
  - Ternopil, Ukraine, 46027
    - TG Therapeutics Investigational Trial Site
  - Vinnytsya, Ukraine, 21005
    - TG Therapeutics Investigational Trial Site
  - Zaporizhia, Ukraine, 69065
    - TG Therapeutics Investigational Trial Site
  - Zaporizhia, Ukraine, 96900
    - TG Therapeutics Investigational Trial Site
  - Zhytomyr, Ukraine, 10002
    - TG Therapeutics Investigational Trial Site
  - Úzhgorod, Ukraine, 88018
    - TG Therapeutics Investigational Trial Site
United States
- California
  - Pasadena, California, United States, 91105
    - TG Therapeutics Investigational Trial Site
- Colorado
  - Denver, Colorado, United States, 80045
    - TG Therapeutics Investigational Trial Site
- Florida
  - Miami, Florida, United States, 33136
    - TG Therapeutics Investigational Trial Site
  - Tampa, Florida, United States, 33612
    - TG Therapeutics Investigational Trial Site
- Illinois
  - Northbrook, Illinois, United States, 60062
    - TG Therapeutics Investigational Trial Site
- Kansas
  - Kansas City, Kansas, United States, 66160
    - TG Therapeutics Investigational Trial Site
- Michigan
  - Detroit, Michigan, United States, 48201
    - TG Therapeutics Investigational Trial Site
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - TG Therapeutics Investigational Trial Site
- New Jersey
  - Teaneck, New Jersey, United States, 07666
    - TG Therapeutics Investigational Trial Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - TG Therapeutics Investigational Trial Site
- New York
  - Amherst, New York, United States, 14266
    - TG Therapeutics Investigational Trial Site
- Ohio
  - Columbus, Ohio, United States, 43214
    - TG Therapeutics Investigational Trial Site
  - Westerville, Ohio, United States, 43081
    - TG Therapeutics Investigational Trial Site
- Tennessee
  - Knoxville, Tennessee, United States, 37922
    - TG Therapeutics Investigational Trial Site
- Texas
  - Dallas, Texas, United States, 75246
    - TG Therapeutics Investigational Trial Site
  - Frisco, Texas, United States, 75034
    - TG Therapeutics Investigational Trial Site
  - Round Rock, Texas, United States, 78681
    - TG Therapeutics Investigational Trial Site
  - San Antonio, Texas, United States, 78258
    - TG Therapeutics Investigational Trial Site
- Washington
  - Seattle, Washington, United States, 98109
    - TG Therapeutics Investigational Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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:
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
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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ublituximab Infusions 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.	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. Other Names: TG-1101

Participant Group / Arm

Intervention / Treatment

Experimental: Ublituximab Infusions

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.

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.

Other Names:

TG-1101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Relapse Rate (ARR) Time Frame: Up to Week 336	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TG Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2019

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

October 16, 2019

First Posted (Actual)

October 18, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

TG1101-RMS303
2019-003625-16 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relapsing Multiple Sclerosis (RMS)

TG Therapeutics, Inc.

Completed

Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 ) (ULTIMATE 1)

Relapsing Multiple Sclerosis (RMS)

United States
Merck KGaA, Darmstadt, Germany

Completed

Effects of Cladribine Tablets on the PK of Microgynon®

Relapsing Multiple Sclerosis (RMS)

Germany, Poland
TG Therapeutics, Inc.

Completed

Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (ULTIMATE II)

Relapsing Multiple Sclerosis (RMS)

United States
Novartis Pharmaceuticals

Active, not recruiting

Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients

Relapsing Multiple Sclerosis (RMS)

China
Merck KGaA, Darmstadt, Germany
Merck Serono Middle East FZ LLC

Completed

Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)

Relapsing Multiple Sclerosis (RMS)

Bulgaria, Poland, Argentina, Hungary, Korea, Republic of, Saudi Arabia, Egypt, Algeria, Bahrain, Iran, Islamic Republic of, Kuwait, Lebanon, Morocco
Biogen

Withdrawn

Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

Relapsing-Remitting Multiple Sclerosis | Relapsing Forms of Multiple Sclerosis
The Cleveland Clinic
University Hospitals Cleveland Medical Center

Completed

Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS

Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple Sclerosis

United States
University of California, Los Angeles

Unknown

Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition

Relapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple Sclerosis

United States
Biogen
AbbVie

Terminated

Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019 (EXTEND)

Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis

United States, Denmark, Italy, United Kingdom, Czechia, Canada, Hungary, Spain, Australia, Israel, Georgia, Serbia, Russian Federation, Ukraine, India, Poland, Brazil, France, Argentina, Germany, Greece, Ireland, Mexico, Moldova, Republic... and more
EMD Serono
Pfizer

Completed

Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis

Relapsing-remitting Multiple Sclerosis

United States, United Kingdom, Argentina, Austria, Brazil, France, Germany, Italy, Netherlands, Russian Federation, Spain, Switzerland

Clinical Trials on Ublituximab

University of Colorado, Denver

Completed

Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma

Follicular Lymphoma | Marginal Zone Lymphoma

United States
Laboratoire français de Fractionnement et de Biotechnologies

Completed

LFB-R603 Dose Finding in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia

France
TG Therapeutics, Inc.

Recruiting

Study to Evaluate Efficacy When Transitioning From a Current Disease Modifying Therapy (DMT) to Ublituximab (ENHANCE)

Relapsing Multiple Sclerosis

United States
TG Therapeutics, Inc.

Completed

Ublituximab + Ibrutinib in Select B-cell Malignancies

Mantle Cell Lymphoma | Chronic Lymphocytic Leukemia

United States
Weill Medical College of Cornell University
TG Therapeutics, Inc.

Terminated

Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy

Chronic Lymphocytic Leukemia | CLL/SLL | CLL Progression

United States
TG Therapeutics, Inc.

Completed

Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL) (GENUINE)

Chronic Lymphocytic Leukemia

United States, Israel
TG Therapeutics, Inc.

Terminated

A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304

Chronic Lymphocytic Leukemia

United States, Poland, Italy, United Kingdom
Johns Hopkins University

Completed

Ublituximab for Acute Neuromyelitis Optica (NMO) Relapses

Neuromyelitis Optica | Neuromyelitis Optica Spectrum Disorder

United States
TG Therapeutics, Inc.

Completed

Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis

United States
TG Therapeutics, Inc.

Terminated

Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma

Follicular Lymphoma | Small Lymphocytic Lymphoma

United States

An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Relapsing Multiple Sclerosis (RMS)

Clinical Trials on Ublituximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations