TrialPath
Recruiting

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 · TG Therapeutics, Inc.
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official 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
About this study
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.
Eligibility criteria
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 design
Enrollment target: 350 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-01
Estimated completion: 2029-05-30
Last updated: 2026-07-20
Interventions
Drug: UblituximabDrug: UblituximabDevice: Prefilled pen
Primary outcomes
  • Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab (Up to Week 12)
Sponsor
TG Therapeutics, Inc. · industry
Contacts & investigators
ContactTG Therapeutics Clinical Support Team · contact · clinicalsupport@tgtxinc.com · 1-877-575-8489
All locations (39)
TG Therapeutics Investigational Trial SiteRecruiting
Bihać, Bosnia and Herzegovina
TG Therapeutics Investigational Trial SiteRecruiting
Sarajevo, Bosnia and Herzegovina
TG Therapeutics Investigational Trial SiteRecruiting
Tuzla, Bosnia and Herzegovina
TG Therapeutics Investigational Trial SiteRecruiting
Zenica, Bosnia and Herzegovina
TG Therapeutics Investigational Trial SiteRecruiting
Tbilisi, Georgia
TG Therapeutics Investigational Trial SiteRecruiting
Tbilisi, Georgia
TG Therapeutics Investigational Trial SiteRecruiting
Tbilisi, Georgia
TG Therapeutics Investigational Trial SiteRecruiting
Tbilisi, Georgia
TG Therapeutics Investigational Trial SiteRecruiting
Shtip, North Macedonia
TG Therapeutics Investigational Trial SiteRecruiting
Skopje, North Macedonia
TG Therapeutics Investigational Trial SiteRecruiting
Bydgoszcz, Poland
TG Therapeutics Investigational Trial SiteRecruiting
Katowice, Poland
TG Therapeutics Investigational Trial SiteRecruiting
Katowice, Poland
TG Therapeutics Investigational Trial SiteRecruiting
Kielce, Poland
TG Therapeutics Investigational Trial SiteRecruiting
Lodz, Poland
TG Therapeutics Investigational Trial SiteRecruiting
Poznan, Poland
TG Therapeutics Investigational Trial SiteRecruiting
Warsaw, Poland
TG Therapeutics Investigational Trial SiteRecruiting
Belgrade, Serbia
TG Therapeutics Investigational Trial SiteRecruiting
Kragujevac, Serbia
TG Therapeutics Investigational Trial SiteRecruiting
Chernihiv, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Chernihiv, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Ivano-Frankivsk, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Ivano-Frankivsk, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Ivano-Frankivsk, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Kyiv, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Kyiv, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Kyiv, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Kyiv, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Kyiv, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Kyiv, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Lviv, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Lviv, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Odesa, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Poltava, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Tbilisi, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Ternopil, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Uzhhorod, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Vinnytsia, Ukraine
TG Therapeutics Investigational Trial SiteRecruiting
Vinnytsia, Ukraine
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) · TrialPath