A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)

TG Therapeutics

Status and phase: Not yet enrolling; Phase 2

Conditions: Multiple Sclerosis

Treatments: Device: AI Device; Drug: Ublituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07503873

2025-523757-33-00 (Other Identifier)

TG1101-RMS-SC201

Details and patient eligibility

About

The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC with an AI device versus syringe.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of relapsing multiple sclerosis (RMS) (2017 Revised McDonald criteria).
2. Expanded Disability Status Scale (EDSS) score less than or equal to (≤) 5.5 at screening.
3. Neurologically stable for more than (>) 30 days prior to screening and Day 1.
4. Female participants of childbearing potential must consent to use an 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 received any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
5. Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening.
6. Females who are pregnant or nursing.

Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Part 1: Ublituximab SC

Experimental group

Description:

Participants will receive ublituximab SC, using a syringe at one of three different sites of administration.

Treatment:

Drug: Ublituximab

Drug: Ublituximab

Part 2: Ublituximab SC

Experimental group

Description:

Participants will be randomized to receive ublituximab SC using either the AI device or a syringe.

Treatment:

Drug: Ublituximab

Device: AI Device

Drug: Ublituximab