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NCT07503873RecruitingPhase 2

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)

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

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
350 (estimated)
First submitted
9 Mar 2026
Start date
1 Apr 2026
Primary completion date
31 Jul 2027
Lead sponsor
TG Therapeutics, Inc.
NCT number
NCT07503873
EU CT number
2025-523757-33-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 350
  • From 1 Apr 2026 to the primary completion date, 31 Jul 2027
  • 30 sites in 6 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 received any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
  • Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening.

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.
  • Females who are pregnant or nursing.
    • Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

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

SiteCityCountrySite status
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
RustaviGeorgiaRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
TbilisiGeorgiaRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
ShtipNorth MacedoniaRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
SkopjeNorth MacedoniaRecruiting
Neurocentrum Bydgoszcz sp. z o.o
Coordinator of this site? Confirm its status
BydgoszczPolandRecruiting
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Coordinator of this site? Confirm its status
CracowPolandRecruiting
Care Clinic Sp. Z O.O.
Coordinator of this site? Confirm its status
KatowicePolandRecruiting
NEURO-MEDIC Sp. z o. o.
Coordinator of this site? Confirm its status
KatowicePolandRecruiting
Resmedica Sp. z o.o.
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KielcePolandRecruiting
Centrum Neurologii Krzysztof Selmaj
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ŁódźPolandRecruiting
Wojewódzki Szpital Specjalistyczny w Olsztynie
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OlsztynPolandRecruiting
Ilkowski I Partnerzy sp.p. Lekarzy
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PoznanPolandRecruiting
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
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ZabrzePolandRecruiting
TG Therapeutics Investigational Trial Site
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BelgradeSerbiaRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
KragujevacSerbiaRecruiting
TG Therapeutics Investigational Trial Site
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ChernihivUkraineRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
Ivano-FrankivskUkraineRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
KyivUkraineRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
LvivUkraineRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
OdesaUkraineRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
PoltavaUkraineRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
TernopilUkraineRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
UzhhorodUkraineRecruiting
TG Therapeutics Investigational Trial Site
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VinnytsiaUkraineRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
BihaćBosnia and HerzegovinaRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
MostarBosnia and HerzegovinaRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
SarajevoBosnia and HerzegovinaRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
TuzlaBosnia and HerzegovinaRecruiting
TG Therapeutics Investigational Trial Site
Coordinator of this site? Confirm its status
ZenicaBosnia and HerzegovinaRecruiting

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