Relapsing Multiple SclerosisPhase 3NCT07211633
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
A Phase 3 study testing Ublituximab in people with Relapsing Multiple Sclerosis, run by TG Therapeutics, Inc. at 48 sites in 9 countries.
Trial summary
The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Ublituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 48 sitesin 9 countries
- Study dates
- 9 Jul 2025to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 RMS (2017 Revised McDonald criteria).
- Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
- Neurologically stable for > 30 days prior to Screening and Day 1.
- Female participants of childbearing potential must consent to use a highly 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 previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
- Note: Other Inclusion/Exclusion criteria may apply.
Trial locations and contacts
48 sites in 9 countries.
48 sites in 9 countries
Ukraine12 sites
TG Therapeutics Investigational Trial Site
Cherkasy, 14029
TG Therapeutics Investigational Trial Site
Ivano-Frankivsk, 76000
TG Therapeutics Investigational Trial Site
Ivano-Frankivsk, 76018
TG Therapeutics Investigational Trial Site
Ivano-Frankivsk, 76493
TG Therapeutics Investigational Trial Site
Kyiv, 03037
TG Therapeutics Investigational Trial Site
Kyiv, 03115
TG Therapeutics Investigational Trial Site
Lviv, 79000
TG Therapeutics Investigational Trial Site
Lviv, 79010
TG Therapeutics Investigational Trial Site
Lviv, 79029
TG Therapeutics Investigational Trial Site
Ternopil, 46027
TG Therapeutics Investigational Trial Site
Vinnytsia, 21002
TG Therapeutics Investigational Trial Site
Vinnytsia, 21009
Georgia8 sites
TG Therapeutics Investigational Trial Site
Tbilisi, 0112
TG Therapeutics Investigational Trial Site
Tbilisi, 0114
TG Therapeutics Investigational Trial Site
Tbilisi, 0159
TG Therapeutics Investigational Trial Site
Tbilisi, 0172
TG Therapeutics Investigational Trial Site
Tbilisi, 0178
TG Therapeutics Investigational Trial Site
Tbilisi, 0179
TG Therapeutics Investigational Trial Site
Tbilisi, 0180
TG Therapeutics Investigational Trial Site
Tbilisi, 3700
Czechia6 sites
TG Therapeutics Investigational Trial Site
Brno, 65691
TG Therapeutics Investigational Trial Site
Hradec Králové, 50005
TG Therapeutics Investigational Trial Site
Jihlava, 58601
TG Therapeutics Investigational Trial Site
Ostrava, 70300
TG Therapeutics Investigational Trial Site
Pardubice, 53002
TG Therapeutics Investigational Trial Site
Zlín, 76275
Hungary6 sites
TG Therapeutics Investigational Trial Site
Budapest, H-1033
TG Therapeutics Investigational Trial Site
Budapest, H-1044
TG Therapeutics Investigational Trial Site
Budapest, H-1145
TG Therapeutics Investigational Trial Site
Kaposvár, H-7400
TG Therapeutics Investigational Trial Site
Kistarsca, H-2143
TG Therapeutics Investigational Trial Site
Pécs, H-7623
Bosnia and Herzegovina5 sites
TG Therapeutics Investigational Trial Site
Banja Luka, 78000
TG Therapeutics Investigational Trial Site
Bihać, 77000
TG Therapeutics Investigational Trial Site
Mostar, 71000
TG Therapeutics Investigational Trial Site
Saravejo, 71000
TG Therapeutics Investigational Trial Site
Tulza, 75000
Bulgaria5 sites
TG Therapeutics Investigational Trial Site
Pleven, 5800
TG Therapeutics Investigational Trial Site
Plovdiv, 4000
TG Therapeutics Investigational Trial Site
Sofia, 1000
TG Therapeutics Investigational Trial Site
Sofia, 1113
TG Therapeutics Investigational Trial Site
Veliko Tarnovo, 5000
Croatia2 sites
TG Therapeutics Investigational Trial Site
Varaždin, 42000
TG Therapeutics Investigational Trial Site
Zagreb, 10000
North Macedonia2 sites
TG Therapeutics Investigational Trial Site
Shtip, 7240
TG Therapeutics Investigational Trial Site
Skopje, 1000
Serbia2 sites
TG Therapeutics Investigational Trial Site
Kragujevac, 34 000
TG Therapeutics Investigational Trial Site
Niš, 18000
About this study
Official title: A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis
The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.
Read the detailed description
This is a Phase 3, open label, parallel-group, multicenter study in participants with RMS.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Ublituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UblituximabBiological
Also called TG-1101
Administered as an IV infusion.
UblituximabBiological
Also called TG-1101
Administered as an SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Ublituximab IV | Active comparator | Approved dosage. Receives: Biological: Ublituximab |
| Ublituximab SC Regimen 1 | Experimental | New regimen. Receives: Biological: Ublituximab |
| Ublituximab SC Regimen 2 | Experimental | New regimen. Receives: Biological: Ublituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab
Measured: Up to Week 24
Secondary outcomes (12)
Minimum Plasma Concentration (Cmin) of Ublituximab
Measured: Up to Week 24
Average Concentration at Steady State (Cavg,ss) of Ublituximab
Measured: Up to Week 120
Maximum Plasma Concentration (Cmax) of Ublituximab
Measured: Up to Week 120
Time to Maximum Plasma Concentration (Tmax) of Ublituximab
Measured: Up to Week 120
Last Observed Concentration (Clast) of Ublituximab
Measured: Up to Week 120
Area Under the Curve From Week 0 to Week 120 (AUC0-120) of Ublituximab
Measured: Up to Week 120
Concentration From Time 0 to Time of Last Concentration (AUClast) of Ublituximab
Measured: Up to Week 120
Time of Last Concentration (Tlast) of Ublituximab
Measured: Up to Week 120
Participants B Cell Counts
Measured: Up to Week 120
Incidence of Treatment Emergent Adverse Events (TEAEs)
Measured: Up to Week 120
Total Number of Gadolinium (Gd) enhancing T1 Lesions Per Magnetic Resonance Imaging (MRI) Scan
Measured: Up to Week 96
Total Number of New or Enlarging T2 lesions Per MRI Scan
Measured: Up to Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start9 Jul 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by TG Therapeutics, Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 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
- NCT07211633
- Sponsor's protocol ID
- TG1101-RMS-SC301
- Other IDs
- 2025-521127-73-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07211633
- Acronym / sponsor ID
- TG1101-RMS-SC301
- Conditions
- Relapsing Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.
Detailed description
This is a Phase 3, open label, parallel-group, multicenter study in participants with RMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ublituximab IV | Active comparator | Biological: UblituximabApproved dosage. |
| Ublituximab SC Regimen 1 | Experimental | Biological: UblituximabNew regimen. |
| Ublituximab SC Regimen 2 | Experimental | Biological: UblituximabNew regimen. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of RMS (2017 Revised McDonald criteria).
- Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
- Neurologically stable for > 30 days prior to Screening and Day 1.
- Female participants of childbearing potential must consent to use a highly effective method of contraception from consent and for 6 months after the last dose of ublituximab.
Key exclusion criteria (5 listed)
- 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 previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
- Note: Other Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UblituximabAlso: TG-1101Administered as an IV infusion. | Biological | Ublituximab IV |
| UblituximabAlso: TG-1101Administered as an SC injection. | Biological | Ublituximab SC Regimen 1, Ublituximab SC Regimen 2 |
Primary outcome
Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab
Time frame: Up to Week 24
12 secondary outcomes
Minimum Plasma Concentration (Cmin) of Ublituximab
Time frame: Up to Week 24
Average Concentration at Steady State (Cavg,ss) of Ublituximab
Time frame: Up to Week 120
Maximum Plasma Concentration (Cmax) of Ublituximab
Time frame: Up to Week 120
Time to Maximum Plasma Concentration (Tmax) of Ublituximab
Time frame: Up to Week 120
Last Observed Concentration (Clast) of Ublituximab
Time frame: Up to Week 120
Area Under the Curve From Week 0 to Week 120 (AUC0-120) of Ublituximab
Time frame: Up to Week 120
Concentration From Time 0 to Time of Last Concentration (AUClast) of Ublituximab
Time frame: Up to Week 120
Time of Last Concentration (Tlast) of Ublituximab
Time frame: Up to Week 120
Participants B Cell Counts
Time frame: Up to Week 120
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 120
Total Number of Gadolinium (Gd) enhancing T1 Lesions Per Magnetic Resonance Imaging (MRI) Scan
Time frame: Up to Week 96
Total Number of New or Enlarging T2 lesions Per MRI Scan
Time frame: Up to Week 96
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ublituximab in people with Relapsing Multiple Sclerosis, run by TG Therapeutics, Inc. at 48 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Ukraine, Georgia, Czechia, Hungary, Bosnia and Herzegovina and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab (time frame: Up to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.