NCT07211633Active, not recruitingPhase 3
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 1 Oct 2025
- Start date
- 9 Jul 2025
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- TG Therapeutics, Inc.
- Diseases
- Multiple sclerosis
- NCT number
- NCT07211633
- EU CT number
- 2025-521127-73-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 360
- From 9 Jul 2025 to the primary completion date, 31 Oct 2026
- 40 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
- Note: Other Inclusion/Exclusion criteria may apply.
Other illness
- Active chronic disease of the immune system other than MS or immunodeficiency syndrome.
Other
- Primary-progressive Multiple Sclerosis (PPMS) or inactive Secondary Progressive Multiple Sclerosis (SPMS).
- Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.
Who the study is looking for
- Diagnosis of RMS (2017 Revised McDonald criteria).
- Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
- Neurologically stable for \> 30 days prior to Screening and Day 1.
- Female participants of childbearing potential must consent to use a highly effective method of contraception from consent and for 6 months after the last dose of ublituximab.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center Academica 2008 EOOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Active, not recruiting |
| University Multiprofile Hospital For Active Treatment Saint Georgi EAD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Active, not recruiting |
| Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Medical Center Medica 2005 EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Diagnostic Consultation Center XX-Sofia EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Multiprofile Regional Hospital For Active Treatment Dr. Stefan Cherkezov AD Coordinator of this site? Confirm its status | Veliko Tirnovo | Bulgaria | Active, not recruiting |
| Fakultni Nemocnice U Sv Anny V Brne Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Active, not recruiting |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Active, not recruiting |
| Nemocnice Jihlava prispevkova organizace Coordinator of this site? Confirm its status | Jihlava 1 | Czechia | Active, not recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Active, not recruiting |
| Nemocnice Pardubickeho kraje a.s. Coordinator of this site? Confirm its status | Pardubice | Czechia | Active, not recruiting |
| Krajska Nemocnice T Bati a.s. Coordinator of this site? Confirm its status | Zlin | Czechia | Active, not recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Poliklinika Solmed d.o.o. Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Active, not recruiting |
| Opca Bolnica Varazdin Coordinator of this site? Confirm its status | Varazdin | Croatia | Active, not recruiting |
| University Hospital Centre Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Active, not recruiting |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Active, not recruiting |
| S-Medicon Kft. Coordinator of this site? Confirm its status | Budapest IV | Hungary | Active, not recruiting |
| Budapesti Uzsoki Utcai Korhaz Coordinator of this site? Confirm its status | Budapest XIV | Hungary | Active, not recruiting |
| Somogy Vármegyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Active, not recruiting |
| Kistarcsai Flor Ferenc Korhaz Coordinator of this site? Confirm its status | Kistarcsa | Hungary | Active, not recruiting |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Active, not recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Shtip | North Macedonia | Unknown status |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Skopje | North Macedonia | Unknown status |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Kragujevac | Serbia | Unknown status |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Niš | Serbia | Unknown status |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Cherkasy | Ukraine | Unknown status |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Unknown status |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Ternopil | Ukraine | Unknown status |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Unknown status |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Banja Luka | Bosnia and Herzegovina | Unknown status |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Bihać | Bosnia and Herzegovina | Unknown status |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Mostar | Bosnia and Herzegovina | Unknown status |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Saravejo | Bosnia and Herzegovina | Unknown status |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Tulza | Bosnia and Herzegovina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.