A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)

TG Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Relapsing Multiple Sclerosis

Treatments: Biological: Ublituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07211633

TG1101-RMS-SC301

2025-521127-73-00 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This is a Phase 3, open label, parallel-group, multicenter study in participants with RMS.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 3 patient groups

Ublituximab IV

Active Comparator group

Description:

Approved dosage.

Treatment:

Biological: Ublituximab

Biological: Ublituximab

Ublituximab SC Regimen 1

Experimental group

Description:

New regimen.

Treatment:

Biological: Ublituximab

Biological: Ublituximab

Ublituximab SC Regimen 2

Experimental group

Description:

New regimen.

Treatment:

Biological: Ublituximab

Biological: Ublituximab