MSFrontier

TG1101-RMS-SC301

A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis
Running, not recruitingPhase 3Relapsing MSNCT072116332025-521127-73-00

What it found

Still running

No result yet.

What was tested

Treatment tested

Compared with

What it measured

Main measures

  • Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab

    Up to Week 24

  • Commercially confidential information

Other measures (13)

  • Minimum Plasma Concentration (Cmin) of Ublituximab

    Up to Week 24

    How the body handles the medicine

  • Average Concentration at Steady State (Cavg,ss) of Ublituximab

    Up to Week 120

    How the body handles the medicine

  • Maximum Plasma Concentration (Cmax) of Ublituximab

    Up to Week 120

    How the body handles the medicine

  • Time to Maximum Plasma Concentration (Tmax) of Ublituximab

    Up to Week 120

    How the body handles the medicine

  • Last Observed Concentration (Clast) of Ublituximab

    Up to Week 120

  • Area Under the Curve From Week 0 to Week 120 (AUC0-120) of Ublituximab

    Up to Week 120

  • Concentration From Time 0 to Time of Last Concentration (AUClast) of Ublituximab

    Up to Week 120

  • Time of Last Concentration (Tlast) of Ublituximab

    Up to Week 120

  • Participants B Cell Counts

    Up to Week 120

    Immune response

  • Incidence of Treatment Emergent Adverse Events (TEAEs)

    Up to Week 120

    Safety

Who could take part

Relapsing MS · 18 to 65

Inclusion Criteria: 1. Diagnosis of RMS (2017 Revised McDonald criteria). 2. Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening. 3. Neurologically stable for > 30 days prior to Screening and Day 1. 4. Female participants of childbearing potential must consent to use a highly effective method of contraception from consent and for 6 months after the last dose of ublituximab. Exclusion Criteria: 1. Primary-progressive Multiple Sclerosis (PPMS) or inactive Secondary Progressive Multiple Sclerosis (SPMS). 2. Active chronic disease of the immune system other than MS or immunodeficiency syndrome. 3. Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia. 4. Participants who previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening. Note: Other Inclusion/Exclusion criteria may apply.

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 assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.

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Related trials

History

    1. Started

      Jul 2025

    2. Main results due

      Oct 2026

    3. Finished

      Dec 2028

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