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)

March 26, 2026 updated by: TG Therapeutics, Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Ublituximab SC
Participants will receive ublituximab SC, using a syringe at one of three different sites of administration.
Drug: Ublituximab
Administered as an SC injection by a syringe.
Other Names:
  • TG-1101
Drug: Ublituximab
Administered as an SC injection by AI device.
Other Names:
  • TG-1101
Experimental: Part 2: Ublituximab SC
Participants will be randomized to receive ublituximab SC using either the AI device or a syringe.
Drug: Ublituximab
Administered as an SC injection by a syringe.
Other Names:
  • TG-1101
Drug: Ublituximab
Administered as an SC injection by AI device.
Other Names:
  • TG-1101
Device: AI Device
Ublituximab will be administered as an SC injection by AI device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part 2: Area under the curve (AUC) From Week 0 to Week 12 [AUC(0-W12)] of Ublituximab
Time Frame: Up to Week 12
Up to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Part 1: Plasma Concentrations of Ublituximab
Time Frame: Up to Week 24
Up to Week 24
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to Week 120
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)
Time Frame: Up to Week 96
Up to Week 96
Part 2 : Minimum Plasma Concentration (Cmin) of Ublituximab
Time Frame: Up to Week 12
Up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TG Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 21, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

May 30, 2029

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG1101-RMS-SC201
  • 2025-523757-33-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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