Ublituximab in MS: how injection site and delivery method affect absorption

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial investigates the pharmacokinetics and safety of subcutaneous ublituximab given at various injection sites and compares a prefilled pen versus syringe delivery in adults with relapsing MS. Participants must have relapsing MS, EDSS ≤5.5, and be neurologically stable for at least 30 days. The study uses two delivery methods and aims to determine relative bioavailability and safety signals across administration routes. Exclusion criteria restrict PPMS, active other immune diseases, significant blood cell abnormalities, and recent MS therapies or investigational drugs. Lead sponsor is TG Therapeutics, with trial sites in Bihać, Mostar, and Sarajevo.

Why it matters

Who can join: the full rules

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.

Where it's running

• TG Therapeutics Investigational Trial Site
  Bihać, Bosnia and Herzegovina Recruiting
• TG Therapeutics Investigational Trial Site
  Mostar, Bosnia and Herzegovina Recruiting
• TG Therapeutics Investigational Trial Site
  Sarajevo, Bosnia and Herzegovina Recruiting
• TG Therapeutics Investigational Trial Site
  Tuzla, Bosnia and Herzegovina Recruiting
• TG Therapeutics Investigational Trial Site
  Zenica, Bosnia and Herzegovina Recruiting
• TG Therapeutics Investigational Trial Site
  Rustavi, Georgia Recruiting

Study contacts

• Study coordinator: TG Therapeutics Clinical Support Team
• Email: clinicalsupport@tgtxinc.com
• Phone: 1-877-575-8489

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• REAL-MS: A Look at Autologous Stem Cell Transplant vs High-Efficacy MS Therapies in Real-World Care

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.