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An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04130997
Collaborator
(none)
900
Enrollment
85
Locations
1
Arm
46.4
Anticipated Duration (Months)
10.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
open-label, single-arm, extension studyopen-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 :
Nov 18, 2019
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

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 Names:
  • TG-1101

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Annualized Relapse Rate (ARR) [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    2. Absolute neutrophil count < 1.5 x 10e3/µL

    3. Hematocrit < 24%

    4. Platelet count < 150,000 cell/mm^3

    5. Hypogammaglobulinemia immunoglobulin G (IgG) < 4.0g/L

    6. Active infection

    7. Ongoing pregnancy (female participants)

    8. 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

    9. 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

    10. 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

    11. Participants with unstable disease activity

    12. Presence of malignancy, except for surgically excised basal or squamous cell skin lesions

    13. Vaccination with live virus within 2 months of randomization

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 TG Therapeutics Investigational Trial Site Pasadena California United States 91105
    2 TG Therapeutics Investigational Trial Site Denver Colorado United States 80045
    3 TG Therapeutics Investigational Trial Site Miami Florida United States 33136
    4 TG Therapeutics Investigational Trial Site Tampa Florida United States 33612
    5 TG Therapeutics Investigational Trial Site Northbrook Illinois United States 60062
    6 TG Therapeutics Investigational Trial Site Kansas City Kansas United States 66160
    7 TG Therapeutics Investigational Trial Site Detroit Michigan United States 48201
    8 TG Therapeutics Investigational Trial Site Las Vegas Nevada United States 89106
    9 TG Therapeutics Investigational Trial Site Teaneck New Jersey United States 07666
    10 TG Therapeutics Investigational Trial Site Albuquerque New Mexico United States 87131
    11 TG Therapeutics Investigational Trial Site Amherst New York United States 14266
    12 TG Therapeutics Investigational Trial Site Columbus Ohio United States 43214
    13 TG Therapeutics Investigational Trial Site Westerville Ohio United States 43081
    14 TG Therapeutics Investigational Trial Site Knoxville Tennessee United States 37922
    15 TG Therapeutics Investigational Trial Site Dallas Texas United States 75246
    16 TG Therapeutics Investigational Trial Site Frisco Texas United States 75034
    17 TG Therapeutics Investigational Trial Site Round Rock Texas United States 78681
    18 TG Therapeutics Investigational Trial Site Seattle Washington United States 98109
    19 TG Therapeutics Investigational Trial Site Grodno Belarus 230017
    20 TG Therapeutics Investigational Trial Site Grodno Belarus 320017
    21 TG Therapeutics Investigational Trial Site Minsk Belarus 220114
    22 TG Therapeutics Investigational Trial Site Minsk Belarus 220116
    23 TG Therapeutics Investigational Trial Site Minsk Belarus 220226
    24 TG Therapeutics Investigational Trial Site Osijek Croatia 31000
    25 TG Therapeutics Investigational Trial Site Varazdin Croatia 42000
    26 TG Investigational Trial Site Zagreb Croatia 10000
    27 TG Therapeutics Investigational Trial Site Tbilisi Georgia 00112
    28 TG Therapeutics Investigational Trial Site Tbilisi Georgia 00114
    29 TG Therapeutics Investigational Trial Site Tbilisi Georgia 00159
    30 TG Therapeutics Investigational Trial Site Tbilisi Georgia 00160
    31 TG Therapeutics Investigational Trial Site Tbilisi Georgia 00172
    32 TG Therapeutics Investigational Trial Site Tbilisi Georgia 00179
    33 TG Therapeutics Investigational Trial Site Katowice Poland 40-555
    34 TG Therapeutics Investigational Trial Site Katowice Poland 40-568
    35 TG Therapeutics Investigational Trial Site Katowice Poland 40-684
    36 TG Therapeutics Investigational Trial Site Kraków Poland 31-505
    37 TG Therapeutics Investigational Trial Site Olsztyn Poland 10-561
    38 TG Therapeutics Investigational Trial Site Poznań Poland 61-583
    39 TG Therapeutics Investigational Trial Site Warszawa Poland 04-141
    40 TG Therapeutics Investigational Trial Site Zabrze Poland 04-749
    41 TG Therapeutics Investigational Trial Site Łódź Poland 41-800
    42 TG Therapeutics Investigational Trial Site Arkhangel'sk Russian Federation 163045
    43 TG Therapeutics Investigational Trial Site Barnaul Russian Federation 656045
    44 TG Therapeutics Investigational Trial Site Bryansk Russian Federation 241033
    45 TG Therapeutics Investigational Trial Site Chelyabinsk Russian Federation 454021
    46 TG Therapeutics Investigational Trial Site Ekaterinburg Russian Federation 620102
    47 TG Therapeutics Investigational Trial Site Kemerovo Russian Federation 650066
    48 TG Therapeutics Investigational Trial Site Krasnoyarsk Russian Federation 660037
    49 TG Therapeutics Investigational Trial Site Kursk Russian Federation 305007
    50 TG Therapeutics Investigational Trial Site Moscow Russian Federation 125367
    51 TG Therapeutics Investigational Trial Site Moscow Russian Federation 127015
    52 TG Therapeutics Investigational Trial Site Nizhny Novgorod Russian Federation 603155
    53 TG Therapeutics Investigational Trial Site Novosibirsk Russian Federation 630007
    54 TG Therapeutics Investigational Trial Site Novosibirsk Russian Federation 630087
    55 TG Therapeutics Investigational Trial Site Pyatigorsk Russian Federation 357538
    56 TG Therapeutics Investigational Trial Site Saint Petersburg Russian Federation 197002
    57 TG Therapeutics Investigational Trial Site Saint Petersburg Russian Federation 197110
    58 TG Therapeutics Investigational Trial Site Saint Petersburg Russian Federation 197376
    59 TG Therapeutics Investigational Trial Site Saransk Russian Federation 430032
    60 TG Therapeutics Investigational Trial Site Smolensk Russian Federation 214018
    61 TG Therapeutics Investigational Trial Site Tomsk Russian Federation 634050
    62 TG Therapeutics Investigational Trial Site Tyumen Russian Federation 625000
    63 TG Therapeutics Investigational Trial Site Ufa Russian Federation 450005
    64 TG Therapeutics Investigational Trial Site Belgrade Serbia 11000
    65 TG Therapeutics Investigational Trial Site Kragujevac Serbia 34000
    66 TG Therapeutics Investigational Trial Site Cherkasy Ukraine 18009
    67 TG Therapeutics Investigational Trial Site Chernihiv Ukraine 14001
    68 TG Therapeutics Investigational Trial Site Chernihiv Ukraine 14029
    69 TG Therapeutics Investigational Trial Site Chernivtsi Ukraine 58002
    70 TG Therapeutics Investigational Trial Site Ivano-Frankivs'k Ukraine 76008
    71 TG Therapeutics Investigational Trial Site Kharkiv Ukraine 61058
    72 TG Therapeutics Investigational Trial Site Kharkiv Ukraine 61103
    73 TG Therapeutics Investigational Trial Site Kharkiv Ukraine 61176
    74 TG Therapeutics Investigational Trial Site Kyiv Ukraine 03037
    75 TG Therapeutics Investigational Trial Site Kyiv Ukraine 03115
    76 TG Therapeutics Investigational Trial Site Lviv Ukraine 79000
    77 TG Therapeutics Investigational Trial Site Lviv Ukraine 79010
    78 TG Therapeutics Investigational Trial Site Odesa Ukraine 65009
    79 TG Therapeutics Investigational Trial Site Poltava Ukraine 36011
    80 TG Therapeutics Investigational Trial Site Ternopil Ukraine 46027
    81 TG Therapeutics Investigational Trial Site Vinnytsya Ukraine 21005
    82 TG Therapeutics Investigational Trial Site Zaporizhia Ukraine 69065
    83 TG Therapeutics Investigational Trial Site Zaporizhia Ukraine 96900
    84 TG Therapeutics Investigational Trial Site Zhytomyr Ukraine 10002
    85 TG Therapeutics Investigational Trial Site Úzhgorod Ukraine 88018

    Sponsors and Collaborators

    • TG Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TG Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04130997
    Other Study ID Numbers:
    • TG1101-RMS303
    • 2019-003625-16
    First Posted:
    Oct 18, 2019
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Aug 22, 2022