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

Not Applicable

Recruiting

• Conditions: Relapsing Multiple Sclerosis
• Interventions: Biological: Ublituximab

• Registration Number: NCT07211633
• Lead Sponsor: TG Therapeutics, Inc.

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2025-07-09
• Status Verified: 2025-10
• Study First Submitted: 2025-10-01
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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 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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ublituximab IV	Ublituximab	Approved dosage.
Ublituximab SC Regimen 1	Ublituximab	New regimen.
Ublituximab SC Regimen 2	Ublituximab	New regimen.

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) from 0 to Week 24 of Ublituximab	Up to Week 24

Secondary Outcome Measures

Name	Time	Method
Participants B Cell Counts	Up to Week 120
Incidence of Treatment Emergent Adverse Events (TEAE)	Up to Week 120
Total Number of Gadolinium (Gd) enhancing T1 Lesions Per Magnetic Resonance Imaging (MRI) Scan	Up to Week 96
Total Number of New or Enlarging T2 lesions Per MRI Scan	Up to Week 96

Trial Locations

Locations (1)

TG Therapeutics Investigational Trial Site; 🇺🇦 Vinnytsia, Ukraine