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.
- Diseases
- Multiple sclerosis
- 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
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Rustavi | Georgia | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Shtip | North Macedonia | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Skopje | North Macedonia | Recruiting |
| Neurocentrum Bydgoszcz sp. z o.o Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Care Clinic Sp. Z O.O. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| NEURO-MEDIC Sp. z o. o. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Resmedica Sp. z o.o. Coordinator of this site? Confirm its status | Kielce | Poland | Recruiting |
| Centrum Neurologii Krzysztof Selmaj Coordinator of this site? Confirm its status | Łódź | Poland | Recruiting |
| Wojewódzki Szpital Specjalistyczny w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Recruiting |
| Ilkowski I Partnerzy sp.p. Lekarzy Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Zabrze | Poland | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Kragujevac | Serbia | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Chernihiv | Ukraine | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Lviv | Ukraine | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Odesa | Ukraine | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Poltava | Ukraine | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Ternopil | Ukraine | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Uzhhorod | Ukraine | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Bihać | Bosnia and Herzegovina | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Mostar | Bosnia and Herzegovina | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Sarajevo | Bosnia and Herzegovina | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Tuzla | Bosnia and Herzegovina | Recruiting |
| TG Therapeutics Investigational Trial Site Coordinator of this site? Confirm its status | Zenica | Bosnia and Herzegovina | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.