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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.
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

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical Center Academica 2008 EOOD
Coordinator of this site? Confirm its status
PlevenBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Coordinator of this site? Confirm its status
PlovdivBulgariaActive, not recruiting
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Coordinator of this site? Confirm its status
SofiaBulgariaActive, not recruiting
Medical Center Medica 2005 EOOD
Coordinator of this site? Confirm its status
SofiaBulgariaActive, not recruiting
Diagnostic Consultation Center XX-Sofia EOOD
Coordinator of this site? Confirm its status
SofiaBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Coordinator of this site? Confirm its status
SofiaBulgariaActive, not recruiting
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Coordinator of this site? Confirm its status
SofiaBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Coordinator of this site? Confirm its status
SofiyaBulgariaActive, not recruiting
Multiprofile Regional Hospital For Active Treatment Dr. Stefan Cherkezov AD
Coordinator of this site? Confirm its status
Veliko TirnovoBulgariaActive, not recruiting
Fakultni Nemocnice U Sv Anny V Brne
Coordinator of this site? Confirm its status
Brno-StredCzechiaActive, not recruiting
Fakultni nemocnice Hradec Kralove
Coordinator of this site? Confirm its status
Hradec KrálovéCzechiaActive, not recruiting
Nemocnice Jihlava prispevkova organizace
Coordinator of this site? Confirm its status
Jihlava 1CzechiaActive, not recruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaActive, not recruiting
Nemocnice Pardubickeho kraje a.s.
Coordinator of this site? Confirm its status
PardubiceCzechiaActive, not recruiting
Krajska Nemocnice T Bati a.s.
Coordinator of this site? Confirm its status
ZlinCzechiaActive, not recruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
Poliklinika Solmed d.o.o.
Coordinator of this site? Confirm its status
Grad ZagrebCroatiaActive, not recruiting
Opca Bolnica Varazdin
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VarazdinCroatiaActive, not recruiting
University Hospital Centre Zagreb
Coordinator of this site? Confirm its status
ZagrebCroatiaActive, not recruiting
Clinexpert Kft.
Coordinator of this site? Confirm its status
Budapest IIIHungaryActive, not recruiting
S-Medicon Kft.
Coordinator of this site? Confirm its status
Budapest IVHungaryActive, not recruiting
Budapesti Uzsoki Utcai Korhaz
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Budapest XIVHungaryActive, not recruiting
Somogy Vármegyei Kaposi Mór Oktató Kórház
Coordinator of this site? Confirm its status
KaposvárHungaryActive, not recruiting
Kistarcsai Flor Ferenc Korhaz
Coordinator of this site? Confirm its status
KistarcsaHungaryActive, not recruiting
University of Pecs
Coordinator of this site? Confirm its status
PécsHungaryActive, not recruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
ShtipNorth MacedoniaUnknown status
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
SkopjeNorth MacedoniaUnknown status
TG Therapeutics Investigational Trial Site
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KragujevacSerbiaUnknown status
TG Therapeutics Investigational Trial Site
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NišSerbiaUnknown status
TG Therapeutics Investigational Trial Site
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CherkasyUkraineUnknown status
TG Therapeutics Investigational Trial Site
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Ivano-FrankivskUkraineUnknown status
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
KyivUkraineUnknown status
TG Therapeutics Investigational Trial Site
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LvivUkraineUnknown status
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
TernopilUkraineUnknown status
TG Therapeutics Investigational Trial Site
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VinnytsiaUkraineUnknown status
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
Banja LukaBosnia and HerzegovinaUnknown status
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
BihaćBosnia and HerzegovinaUnknown status
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
MostarBosnia and HerzegovinaUnknown status
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
SaravejoBosnia and HerzegovinaUnknown status
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
TulzaBosnia and HerzegovinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.