NCT07211633|Active Not RecruitingPhase 3FDA Drug

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

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

TG Therapeutics, Inc.ClinicalTrials.gov

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2 other identifiers

TG1101-RMS-SC3012025-521127-73-00

Study Type

interventional

Target

360

Locations

9 countries

Sites

Timeline

RegisteredOct 2025

StartedJul 2025

CompletionDec 2028

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

360

participants targeted

Target at P50-P75 for phase_3

Timeline

29mo left

Started Jul 2025

Typical duration for phase_3

Geographic Reach

9 countries

48 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.5 years study duration

Study Progress31%

Jul 2025Dec 2028

Study Start

First participant enrolled

July 9, 2025

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2025

Completed

7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected

2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

October 1, 2025

Last Update Submit

July 16, 2026

Conditions

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (12)

Minimum Plasma Concentration (Cmin) of Ublituximab
Up to Week 24
Average Concentration at Steady State (Cavg,ss) of Ublituximab
Up to Week 120
Maximum Plasma Concentration (Cmax) of Ublituximab
Up to Week 120
Time to Maximum Plasma Concentration (Tmax) of Ublituximab
Up to Week 120
Last Observed Concentration (Clast) of Ublituximab
Up to Week 120
+7 more secondary outcomes

Study Arms (3)

Ublituximab IV

ACTIVE COMPARATOR

Approved dosage.

Biological: Ublituximab

Ublituximab SC Regimen 1

EXPERIMENTAL

New regimen.

Biological: Ublituximab

Ublituximab SC Regimen 2

EXPERIMENTAL

New regimen.

Biological: Ublituximab

Interventions

UblituximabBIOLOGICAL

Administered as an IV infusion.

Also known as: TG-1101

Ublituximab IV

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.