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.
Key facts
- Who runs it
- TG Therapeutics, Inc.
- Where
- Shtip and Skopje, North MacedoniaSee the 2 sitesAlso in 5 other countries, 28 sites
- Trial code
- 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)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 350 people, planned
- Started
- 1 Apr 2026
- Expected to end
- 30 May 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- Ublituximab
- Prefilled pen
- Record updated
- 29 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with relapsing multiple sclerosis who are neurologically stable. It studies ublituximab given under the skin.
- Age
- 18 to 65 years
- Sex
- Women and men can join.
- Disease stage
- Relapsing multiple sclerosis (RMS). EDSS score of 5.5 or lower at screening. No neurological change for more than 30 days before screening and Day 1.
- Earlier treatment
- Cannot have had any approved MS therapy or any investigational agent within 5 half-lives of the medication before screening.
Main reasons for not taking part
- Primary-progressive MS or inactive secondary progressive MS
- Active chronic immune system disease other than MS, or immunodeficiency syndrome
- Significantly impaired bone marrow function, or significant leukopenia or thrombocytopenia
- Pregnant or nursing women
- Women who can have children must agree to effective contraception until 6 months after the last dose
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in North Macedonia
Also in 5 other countries, 28 sites
- ShtipHospital not named in the registryContact: TG Therapeutics Clinical Support TeamTaking people
- SkopjeHospital not named in the registryContact: TG Therapeutics Clinical Support TeamTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Part 1: Ublituximab SCTreatment being tested
Participants will receive ublituximab SC, using a syringe at one of three different sites of administration.
Treatment: Ublituximab
- Part 2: Ublituximab SCTreatment being tested
Participants will be randomized to receive ublituximab SC using either the prefilled pen or a syringe.
Treatment: Ublituximab and Prefilled pen
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Ublituximab Injections Under the Skin in Multiple Sclerosis, by Injection Site and DeviceGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07503873, who can take part
- Record updated
- 29 October 2026