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)
August 20, 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 administered with a prefilled pen versus syringe.
Study Overview
Status
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
- Name: TG Therapeutics Clinical Support Team
- Phone Number: 1-877-575-8489
- Email: clinicalsupport@tgtxinc.com
Study Locations
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Bihać, Bosnia and Herzegovina, 77000
- Recruiting
- TG Therapeutics Investigational Trial Site
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Sarajevo, Bosnia and Herzegovina, 71000
- Recruiting
- TG Therapeutics Investigational Trial Site
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Tuzla, Bosnia and Herzegovina, 75000
- Recruiting
- TG Therapeutics Investigational Trial Site
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Zenica, Bosnia and Herzegovina, 72000
- Recruiting
- TG Therapeutics Investigational Trial Site
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Tbilisi, Georgia, 101
- Recruiting
- TG Therapeutics Investigational Trial Site
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Tbilisi, Georgia, 114
- Recruiting
- TG Therapeutics Investigational Trial Site
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Tbilisi, Georgia, 159
- Recruiting
- TG Therapeutics Investigational Trial Site
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Tbilisi, Georgia, 179
- Recruiting
- TG Therapeutics Investigational Trial Site
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Shtip, North Macedonia, 2000
- Recruiting
- TG Therapeutics Investigational Trial Site
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Skopje, North Macedonia, 1000
- Recruiting
- TG Therapeutics Investigational Trial Site
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Bydgoszcz, Poland, 85-796
- Recruiting
- TG Therapeutics Investigational Trial Site
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Katowice, Poland, 40-686
- Recruiting
- TG Therapeutics Investigational Trial Site
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Katowice, Poland, 40-568
- Recruiting
- TG Therapeutics Investigational Trial Site
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Kielce, Poland, 25-726
- Recruiting
- TG Therapeutics Investigational Trial Site
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Lodz, Poland, 90-324
- Recruiting
- TG Therapeutics Investigational Trial Site
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Poznan, Poland, 61-853
- Recruiting
- TG Therapeutics Investigational Trial Site
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Warsaw, Poland, 04-141
- Recruiting
- TG Therapeutics Investigational Trial Site
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Belgrade, Serbia, 11000
- Recruiting
- TG Therapeutics Investigational Trial Site
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Kragujevac, Serbia, 34 000
- Recruiting
- TG Therapeutics Investigational Trial Site
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Chernihiv, Ukraine, 14001
- Recruiting
- TG Therapeutics Investigational Trial Site
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Chernihiv, Ukraine, 14029
- Recruiting
- TG Therapeutics Investigational Trial Site
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Ivano-Frankivsk, Ukraine, 76018
- Recruiting
- TG Therapeutics Investigational Trial Site
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Ivano-Frankivsk, Ukraine, 76493
- Recruiting
- TG Therapeutics Investigational Trial Site
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Ivano-Frankivsk, Ukraine, 76008
- Recruiting
- TG Therapeutics Investigational Trial Site
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Kyiv, Ukraine, 2000
- Recruiting
- TG Therapeutics Investigational Trial Site
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Kyiv, Ukraine, 2091
- Recruiting
- TG Therapeutics Investigational Trial Site
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Kyiv, Ukraine, 3037
- Recruiting
- TG Therapeutics Investigational Trial Site
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Kyiv, Ukraine, 3110
- Recruiting
- TG Therapeutics Investigational Trial Site
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Kyiv, Ukraine, 4050
- Recruiting
- TG Therapeutics Investigational Trial Site
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Kyiv, Ukraine, 4211
- Recruiting
- TG Therapeutics Investigational Trial Site
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Lviv, Ukraine, 79010
- Recruiting
- TG Therapeutics Investigational Trial Site
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Lviv, Ukraine, 79029
- Recruiting
- TG Therapeutics Investigational Trial Site
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Odesa, Ukraine, 65009
- Recruiting
- TG Therapeutics Investigational Trial Site
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Poltava, Ukraine, 36011
- Recruiting
- TG Therapeutics Investigational Trial Site
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Tbilisi, Ukraine, 159
- Recruiting
- TG Therapeutics Investigational Trial Site
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Ternopil, Ukraine, 46014
- Recruiting
- TG Therapeutics Investigational Trial Site
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Uzhhorod, Ukraine, 88018
- Recruiting
- TG Therapeutics Investigational Trial Site
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Vinnytsia, Ukraine, 21001
- Recruiting
- TG Therapeutics Investigational Trial Site
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Vinnytsia, Ukraine, 21009
- Recruiting
- TG Therapeutics Investigational Trial Site
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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:
- 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.
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 |
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Experimental: Part 1: Ublituximab SC
Participants will receive ublituximab SC, using a syringe at one of three different sites of administration.
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Administered as an SC injection by a syringe.
Other Names:
Administered as an SC injection by prefilled pen.
Other Names:
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Experimental: Part 2: Ublituximab SC
Participants will be randomized to receive ublituximab SC using either the prefilled pen or a syringe.
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Administered as an SC injection by a syringe.
Other Names:
Administered as an SC injection by prefilled pen.
Other Names:
Ublituximab will be administered as an SC injection by prefilled pen.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab
Time Frame: Up to Week 12
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Up to Week 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Part 1: Plasma Concentrations of Ublituximab
Time Frame: Up to Week 24
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Up to Week 24
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to Week 120
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Up to Week 120
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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
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Up to Week 96
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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
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pre-dose and at multiple timepoints post-dose up to Week 120
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Maximum Plasma Concentration at steady state (Cmaxss) of Ublituximab
Time Frame: pre-dose and at multiple timepoints post-dose up to Week 120
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pre-dose and at multiple timepoints post-dose up to Week 120
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
April 1, 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)
August 21, 2026
Last Update Submitted That Met QC Criteria
August 20, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TG1101-RMS-SC201
- 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 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.