MSFrontier

TG1101-RMS303

An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis
Running, not recruitingPhase 3Relapsing MSNCT041309972024-516680-91-002019-003625-16

What it found

Still running

No result yet.

What was tested

Treatment tested

What it measured

Main measures

  • Annualized Relapse Rate (ARR)

    Up to Week 336

    Relapses

  • Efficacy Endpoints:

  • Relapses: • Annualized Relapse Rate (ARR) is defined as the number of relapses per- subject year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years).

    Relapses

  • MRI parameters: • T1 gadolinium enhancing (Gd-enhancing) • T1 hypointense lesions • T2 lesions • Brain atrophy

    MRI lesionsBrain volume loss

  • Disability: • 24-Week Confirmed Disability Progression (CDP) • 24-Week Confirmed Disability Improvement (CDI) • Mean change from baseline in EDSS score

    Disability progression

  • No Evidence of Disease Activity (NEDA): • NEDA is defined as subjects without relapses, MRI activities (no T1 Gd-enhancing lesions and no new/enlarging T2 lesions), and no 24-week confirmed disability progression. • The percent of subjects with no evidence of disease activity

    Disability progressionRelapsesMRI lesions

  • Cognition and Function: • Cognition will be measured by Symbol Digit Modalities Test (SDMT) • Function will be measured by Multiple Sclerosis Functional Composite (MSFC)

    Disability progressionThinking and memory

  • Safety Endpoints: All AEs will be reported and evaluated during the treatment period using NCI CTCAE v.5.0 grading system; the number and severity of infusion-associated events; the number and severity of infectious AEs; any clinically significant changes in laboratory or vital sign measurements; the incidence of anti-drug antibodies

    Immune responseSafety

Other measures (1)

  • Not applicable

Who could take part

Relapsing MS · 18 to 64

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

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Linked trials

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Nov 2019

    2. Main results due

      May 2032

    3. Finished

      May 2032

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