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)

NCT07503873 | Not Yet Recruiting Phase 2 FDA Drug FDA Device

• 2 other identifiers: TG1101-RMS-SC2012025-523757-33-00
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

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 with an AI device versus syringe.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Part 2: Area under the curve (AUC) From Week 0 to Week 12 [AUC(0-W12)] of Ublituximab

  Up to Week 12

Secondary Outcomes (4)

• 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 (Cmin) of Ublituximab

  Up to Week 12

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 AI device or a syringe.

Drug: Ublituximab; Device: AI Device

Interventions

Ublituximab DRUG

Administered as an SC injection by a syringe.

Also known as: TG-1101

Part 1: Ublituximab SC; Part 2: Ublituximab SC

AI Device DEVICE

Ublituximab will be administered as an SC injection by AI device.

Part 2: Ublituximab SC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• TG Therapeutics, Inc.: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ublituximab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

TG Therapeutics Clinical Support Team

CONTACT

1-877-575-8489; clinicalsupport@tgtxinc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 31, 2026
• Study Start: March 21, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): May 30, 2029
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share