Multiple SclerosisPhase 2NCT07503873
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 study testing Ublituximab and Prefilled pen in people with Multiple Sclerosis, run by TG Therapeutics, Inc. at 39 sites in 6 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ublituximab and Prefilled pen
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 39 sitesin 6 countries
- Study dates
- 1 Apr 2026to 30 May 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Primary-progressive multiple sclerosis (PPMS) or inactive secondary progressive multiple sclerosis (SPMS).
- Active chronic disease of the immune system other than MS or immunodeficiency syndrome.
- Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.
- 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.
- Females who are pregnant or nursing.
- Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
Trial locations and contacts
39 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
39 sites in 6 countries
Ukraine20 sites, 20 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Chernihiv, 14001
- Recruiting
TG Therapeutics Investigational Trial Site
Chernihiv, 14029
- Recruiting
TG Therapeutics Investigational Trial Site
Ivano-Frankivsk, 76008
- Recruiting
TG Therapeutics Investigational Trial Site
Ivano-Frankivsk, 76018
- Recruiting
TG Therapeutics Investigational Trial Site
Ivano-Frankivsk, 76493
- Recruiting
TG Therapeutics Investigational Trial Site
Kyiv, 2000
- Recruiting
TG Therapeutics Investigational Trial Site
Kyiv, 2091
- Recruiting
TG Therapeutics Investigational Trial Site
Kyiv, 3037
- Recruiting
TG Therapeutics Investigational Trial Site
Kyiv, 3110
- Recruiting
TG Therapeutics Investigational Trial Site
Kyiv, 4050
- Recruiting
TG Therapeutics Investigational Trial Site
Kyiv, 4211
- Recruiting
TG Therapeutics Investigational Trial Site
Lviv, 79010
- Recruiting
TG Therapeutics Investigational Trial Site
Lviv, 79029
- Recruiting
TG Therapeutics Investigational Trial Site
Odesa, 65009
- Recruiting
TG Therapeutics Investigational Trial Site
Poltava, 36011
- Recruiting
TG Therapeutics Investigational Trial Site
Tbilisi, 159
- Recruiting
TG Therapeutics Investigational Trial Site
Ternopil, 46014
- Recruiting
TG Therapeutics Investigational Trial Site
Uzhhorod, 88018
- Recruiting
TG Therapeutics Investigational Trial Site
Vinnytsia, 21001
- Recruiting
TG Therapeutics Investigational Trial Site
Vinnytsia, 21009
Poland7 sites, 7 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Bydgoszcz, 85-796
- Recruiting
TG Therapeutics Investigational Trial Site
Katowice, 40-568
- Recruiting
TG Therapeutics Investigational Trial Site
Katowice, 40-686
- Recruiting
TG Therapeutics Investigational Trial Site
Kielce, 25-726
- Recruiting
TG Therapeutics Investigational Trial Site
Lodz, 90-324
- Recruiting
TG Therapeutics Investigational Trial Site
Poznan, 61-853
- Recruiting
TG Therapeutics Investigational Trial Site
Warsaw, 04-141
Bosnia and Herzegovina4 sites, 4 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Bihać, 77000
- Recruiting
TG Therapeutics Investigational Trial Site
Sarajevo, 71000
- Recruiting
TG Therapeutics Investigational Trial Site
Tuzla, 75000
- Recruiting
TG Therapeutics Investigational Trial Site
Zenica, 72000
Georgia4 sites, 4 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Tbilisi, 101
- Recruiting
TG Therapeutics Investigational Trial Site
Tbilisi, 114
- Recruiting
TG Therapeutics Investigational Trial Site
Tbilisi, 159
- Recruiting
TG Therapeutics Investigational Trial Site
Tbilisi, 179
North Macedonia2 sites, 2 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Shtip, 2000
- Recruiting
TG Therapeutics Investigational Trial Site
Skopje, 1000
Serbia2 sites, 2 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Belgrade, 11000
- Recruiting
TG Therapeutics Investigational Trial Site
Kragujevac, 34 000
About this study
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
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Ublituximab, Prefilled pen
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UblituximabDrug
Also called TG-1101
Administered as an SC injection by a syringe.
UblituximabDrug
Also called TG-1101
Administered as an SC injection by prefilled pen.
Prefilled penDevice
Ublituximab will be administered as an SC injection by prefilled pen.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Ublituximab SC | Experimental | Participants will receive ublituximab SC, using a syringe at one of three different sites of administration. Receives: Drug: Ublituximab |
| Part 2: Ublituximab SC | Experimental | Participants will be randomized to receive ublituximab SC using either the prefilled pen or a syringe. Receives: Drug: Ublituximab; Device: Prefilled pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab
Measured: Up to Week 12
Secondary outcomes (5)
Part 1: Plasma Concentrations of Ublituximab
Measured: Up to Week 24
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to Week 120
Part 2: Percentage of Participants Reporting Their Level of Satisfaction With the SC Method of Administration of Ublituximab, Assessed by Therapy Administration Satisfaction Questionnaire-Subcutaneous (TASQ-SC)
Measured: Up to Week 96
Part 2: Minimum Plasma Concentration at steady state (Cminss) of Ublituximab
Measured: pre-dose and at multiple timepoints post-dose up to Week 120
Maximum Plasma Concentration at steady state (Cmaxss) of Ublituximab
Measured: pre-dose and at multiple timepoints post-dose up to Week 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Apr 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503873
- Sponsor's protocol ID
- TG1101-RMS-SC201
- Other IDs
- 2025-523757-33-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 9 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No