Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07503873

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)

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

TG Therapeutics Investigational Trial Site, Bihać, Bosnia and Herzegovina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

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 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.

Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

Treatment and study plan

Ublituximab

Drug

Administered as an SC injection by a syringe.

Other names: TG-1101

Prefilled pen

Device

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

Primary outcomes

  1. Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab

    Time frame: Up to Week 12

Secondary outcomes

  1. Part 1: Plasma Concentrations of Ublituximab

    Time frame: Up to Week 24

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to Week 120

  3. 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

  4. Part 2: Minimum Plasma Concentration at steady state (Cminss) of Ublituximab

    Time frame: pre-dose and at multiple timepoints post-dose up to Week 120

  5. Maximum Plasma Concentration at steady state (Cmaxss) of Ublituximab

    Time frame: pre-dose and at multiple timepoints post-dose up to Week 120

Study contacts

Contact information is provided by the study sponsor or research team.

TG Therapeutics Clinical Support Team

CONTACT

[email protected]

1-877-575-8489

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Mar 31, 2026
Registry last updated
Jul 20, 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.

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