Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07211633

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Relapsing Multiple Sclerosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

TG Therapeutics Investigational Trial Site, Banja Luka, Bosnia and Herzegovina

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of RMS (2017 Revised McDonald criteria).
  • Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
  • Neurologically stable for > 30 days prior to Screening and Day 1.
  • 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

  • Primary-progressive Multiple Sclerosis (PPMS) or inactive Secondary Progressive Multiple Sclerosis (SPMS).
  • Active chronic disease of the immune system other than MS or immunodeficiency syndrome.
  • Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.
  • 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.

Treatment and study plan

Ublituximab

Biological

Administered as an IV infusion.

Other names: TG-1101

Primary outcomes

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

    Time frame: Up to Week 24

Secondary outcomes

  1. Minimum Plasma Concentration (Cmin) of Ublituximab

    Time frame: Up to Week 24

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

    Time frame: Up to Week 120

  3. Maximum Plasma Concentration (Cmax) of Ublituximab

    Time frame: Up to Week 120

  4. Time to Maximum Plasma Concentration (Tmax) of Ublituximab

    Time frame: Up to Week 120

  5. Last Observed Concentration (Clast) of Ublituximab

    Time frame: Up to Week 120

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

    Time frame: Up to Week 120

  7. Concentration From Time 0 to Time of Last Concentration (AUClast) of Ublituximab

    Time frame: Up to Week 120

  8. Time of Last Concentration (Tlast) of Ublituximab

    Time frame: Up to Week 120

  9. Participants B Cell Counts

    Time frame: Up to Week 120

  10. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to Week 120

  11. Total Number of Gadolinium (Gd) enhancing T1 Lesions Per Magnetic Resonance Imaging (MRI) Scan

    Time frame: Up to Week 96

  12. Total Number of New or Enlarging T2 lesions Per MRI Scan

    Time frame: Up to Week 96

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Oct 8, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.