NCT07503873|RecruitingPhase 2FDA DrugFDA Device

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)

A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector Device Versus Syringe in Patients With Multiple Sclerosis

TG Therapeutics, Inc.ClinicalTrials.gov

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2 other identifiers

TG1101-RMS-SC2012025-523757-33-00

Study Type

interventional

Target

350

Locations

6 countries

Sites

Timeline

RegisteredMar 2026

StartedApr 2026

CompletionMay 2029

Brief Summary

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 administered with a prefilled pen versus syringe.

Trial Health

On Track

Trial Health Score

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

Enrollment

350

participants targeted

Target at P75+ for phase_2 multiple-sclerosis

Timeline

35mo left

Started Apr 2026

Typical duration for phase_2 multiple-sclerosis

Geographic Reach

6 countries

39 active sites

Status

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

3.2 years study duration

Study Progress11%

Apr 2026May 2029

First Submitted

Initial submission to the registry

March 9, 2026

Completed

22 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed

1 day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2029

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

March 9, 2026

Last Update Submit

July 16, 2026

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab
Up to Week 12

Secondary Outcomes (5)

Part 1: Plasma Concentrations of Ublituximab
Up to Week 24
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Up to Week 120
Part 2: Percentage of Participants Reporting Their Level of Satisfaction With the SC Method of Administration of Ublituximab, Assessed by Therapy Administration Satisfaction Questionnaire-Subcutaneous (TASQ-SC)
Up to Week 96
Part 2: Minimum Plasma Concentration at steady state (Cminss) of Ublituximab
pre-dose and at multiple timepoints post-dose up to Week 120
Maximum Plasma Concentration at steady state (Cmaxss) of Ublituximab
pre-dose and at multiple timepoints post-dose up to Week 120

Study Arms (2)

Part 1: Ublituximab SC

EXPERIMENTAL

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

Drug: Ublituximab

Part 2: Ublituximab SC

EXPERIMENTAL

Participants will be randomized to receive ublituximab SC using either the prefilled pen or a syringe.

Drug: UblituximabDevice: Prefilled pen

Interventions

Prefilled penDEVICE

Ublituximab will be administered as an SC injection by prefilled pen.

Part 2: Ublituximab SC

UblituximabDRUG

Administered as an SC injection by a syringe.

Also known as: TG-1101

Part 1: Ublituximab SCPart 2: Ublituximab SC

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Diagnosis of relapsing multiple sclerosis (RMS) (2017 Revised McDonald criteria).
Expanded Disability Status Scale (EDSS) score less than or equal to (≤) 5.5 at screening.
Neurologically stable for more than (\>) 30 days prior to screening and Day 1.
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.

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 received any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening.
Females who are pregnant or nursing.

Contact the study team to confirm eligibility.