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An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04130997
Recruitment Status : Enrolling by invitation
First Posted : October 18, 2019
Last Update Posted : May 12, 2022
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis (RMS) Biological: Ublituximab Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open-label, single-arm, extension study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

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Arms and Interventions
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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 168.

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 168.

For all participants (RMS301/RMS302/RMS201E), infusion treatment will continue for 168 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 Name: TG-1101


Outcome Measures
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Primary Outcome Measures :
  1. Annualized Relapse Rate (ARR) [ Time Frame: Up to Week 172 ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130997


Locations
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Sponsors and Collaborators
TG Therapeutics, Inc.
More Information
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04130997    
Other Study ID Numbers: TG1101-RMS303
2019-003625-16 ( EudraCT Number )
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases