Ublituximab Injections Under the Skin in Multiple Sclerosis, by Injection Site and Device
Tests ublituximab injected under the skin, using different sites and devices, in multiple sclerosis.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Shtip and Skopje, North MacedoniaSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07503873, who can take part
Where in North Macedonia
- ShtipShtip, North MacedoniaTaking people
- SkopjeSkopje, North MacedoniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- TG Therapeutics, Inc.
- Trial code
- NCT07503873EU 2025-523757-33-00
- Record updated
- 29 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; Active chronic disease of the immune system other than MS or immunodeficiency syndrome; 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.