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
Status: Recruiting
Location: See all (37) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
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 administered with a prefilled pen versus syringe.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
RECRUITING
Bihać
TG Therapeutics Investigational Trial Site
RECRUITING
Sarajevo
TG Therapeutics Investigational Trial Site
RECRUITING
Tuzla
TG Therapeutics Investigational Trial Site
RECRUITING
Zenica
Georgia
TG Therapeutics Investigational Trial Site
RECRUITING
Tbilisi
TG Therapeutics Investigational Trial Site
RECRUITING
Tbilisi
TG Therapeutics Investigational Trial Site
RECRUITING
Tbilisi
TG Therapeutics Investigational Trial Site
RECRUITING
Tbilisi
Poland
TG Therapeutics Investigational Trial Site
RECRUITING
Bydgoszcz
TG Therapeutics Investigational Trial Site
RECRUITING
Katowice
TG Therapeutics Investigational Trial Site
RECRUITING
Katowice
TG Therapeutics Investigational Trial Site
RECRUITING
Kielce
TG Therapeutics Investigational Trial Site
RECRUITING
Lodz
TG Therapeutics Investigational Trial Site
RECRUITING
Poznan
TG Therapeutics Investigational Trial Site
RECRUITING
Warsaw
Serbia
TG Therapeutics Investigational Trial Site
RECRUITING
Belgrade
TG Therapeutics Investigational Trial Site
RECRUITING
Kragujevac
Ukraine
TG Therapeutics Investigational Trial Site
RECRUITING
Chernihiv
TG Therapeutics Investigational Trial Site
RECRUITING
Chernihiv
TG Therapeutics Investigational Trial Site
RECRUITING
Ivano-frankivsk
TG Therapeutics Investigational Trial Site
RECRUITING
Ivano-frankivsk
TG Therapeutics Investigational Trial Site
RECRUITING
Ivano-frankivsk
TG Therapeutics Investigational Trial Site
RECRUITING
Kyiv
TG Therapeutics Investigational Trial Site
RECRUITING
Kyiv
TG Therapeutics Investigational Trial Site
RECRUITING
Kyiv
TG Therapeutics Investigational Trial Site
RECRUITING
Kyiv
TG Therapeutics Investigational Trial Site
RECRUITING
Kyiv
TG Therapeutics Investigational Trial Site
RECRUITING
Kyiv
TG Therapeutics Investigational Trial Site
RECRUITING
Lviv
TG Therapeutics Investigational Trial Site
RECRUITING
Lviv
TG Therapeutics Investigational Trial Site
RECRUITING
Odesa
TG Therapeutics Investigational Trial Site
RECRUITING
Poltava
TG Therapeutics Investigational Trial Site
RECRUITING
Tbilisi
TG Therapeutics Investigational Trial Site
RECRUITING
Ternopil
TG Therapeutics Investigational Trial Site
RECRUITING
Uzhhorod
TG Therapeutics Investigational Trial Site
RECRUITING
Vinnytsia
TG Therapeutics Investigational Trial Site
RECRUITING
Vinnytsia
Contact Information
Primary
TG Therapeutics Clinical Support Team
clinicalsupport@tgtxinc.com
1-877-575-8489
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2029-05-30
Participants
Target number of participants: 350
Treatments
Experimental: Part 1: Ublituximab SC
Participants will receive ublituximab SC, using a syringe at one of three different sites of administration.
Experimental: Part 2: Ublituximab SC
Participants will be randomized to receive ublituximab SC using either the prefilled pen or a syringe.
Related Therapeutic Areas
Sponsors
Leads: TG Therapeutics, Inc.