Relapsing Multiple SclerosisPhase 2/3NCT07220252
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
A Phase 2/3 study testing Ublituximab and Fingolimod in people with Relapsing Multiple Sclerosis, run by TG Therapeutics, Inc. at 6 sites in 3 countries.
Trial summary
The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Ublituximab and Fingolimod
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Jul 2026to 30 Jun 2033
- Phase
- Phase 2/3
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of RMS.
- EDSS at screening: 0-5.5, inclusive.
- Neurologic stability for ≥ 30 days prior to screening, and between screening and Week 1 Day 1 (W1D1).
- 1. Participants must have completed Part A (Week 24 visit) or Part B (Week 96 visit) to be eligible for Part C.
Who cannot join
- Known presence or suspicion of other neurologic disorders that may mimic MS.
- Prior treatments:
- Systemic corticosteroids (>0.1 milligrams/kilogram/day [mg/kg/day], or >5 milligrams/day [mg/day] of prednisone equivalent) or adrenocorticotropic hormone (ACTH) within 30 days prior to the screening MRI scan (note: Topical, ophthalmic, or inhaled corticosteroids are permitted).
- High dose intravenous immunoglobulin (IVIG) or subcutaneous IG (SCIG) within 2 months prior to W1D1.
- Treatment with anti-CD20 or other B cell directed treatment at any time.
- Treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone at any time.
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- Additional Exclusion Criteria for Part B Only (Relevant to Fingolimod Treatment):
- Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time.
- The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics.
- 1. If the absolute lymphocyte count (ALC) is outside the specified range the participant will not be eligible to receive ublituximab in Part C.
- Note: Other protocol-specified inclusion/exclusion criteria may apply
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Poland4 sites, 4 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Gdansk, 80-952
- Not yet recruiting
TG Therapeutics Investigational Trial Site
Poznan, 60-355
- Recruiting
TG Therapeutics Investigational Trial Site
Rzeszów, 35-301
- Recruiting
TG Therapeutics Investigational Trial Site
Warsaw, 04-730
United States1 site, 1 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Salt Lake City, Utah, 84113
Slovakia1 site, 1 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Bratislava, 83340
About this study
Official title: Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Ublituximab, Placebo, Fingolimod
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UblituximabDrug
Also called TG-1101, BRIUMVI
Administered as an intravenous (IV) infusion.
PlaceboDrug
Oral capsule.
PlaceboDrug
IV infusion.
FingolimodDrug
Oral capsule.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Ublituximab | Experimental | New Regimen Receives: Drug: Ublituximab |
| Part B: Ublituximab | Experimental | New Regimen Receives: Drug: Ublituximab |
| Part B: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Part B: Fingolimod | Experimental | Not described Receives: Drug: Fingolimod |
| Part B: IV Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Part C: OLE | Experimental | Not described Receives: Drug: Ublituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab
Measured: Predose and multiple timepoints up to Week 24
Part A: Maximum Observed Concentration (Cmax) of Ublituximab
Measured: Day 1 and Day 15
Part A: Participant B Cell Counts
Measured: Up to Week 24
Part B: Annualized Relapse Rate (ARR)
Measured: Up to 96 weeks
Part C: Annualized Relapse Rate (ARR)
Measured: Up to 168 weeks
Secondary outcomes (13)
Part A, B and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured: Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks
Part A, B and C: Number of Participants With Change in Columbia-Suicide Severity Rating Scale (C-SSRS )
Measured: Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks
Part A: Serum Concentrations of Ublituximab
Measured: Up to Week 24
Part A and B: Percentage of Participants with Treatment-emergent Anti-drug Antibodies (ADAs) to Ublituximab
Measured: Part A: Up to Week 24; Part B: Up to 96 weeks
Part A and B: Number of Gadolinium Enhancing (Gd-enhancing) T1 Lesions per Magnetic Resonance Imaging (MRI) Scan
Measured: Part A: Up to Week 24; Part B: Up to 96 weeks
Part A and B: Number of New and/or enlarging T2 Hyperintense Lesions (NELs) per MRI Scan
Measured: Part A: Up to Week 24; Part B: Up to 96 weeks
Past A: Annualized Relapse Rate
Measured: Up to Week 24
Part A and C: Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Measured: Part A: Baseline, up to Week 24; Part C: Baseline, up to 168 weeks
Part B: Pharmacokinetics (PK) Serum Concentration of Ublituximab
Measured: Up to Week 96
Part B: Percentage of Participants with CD19+ B cell counts ≤10 cells/uL
Measured: Up to 96 weeks
Part B: Annualized Relapse Rate ARR
Measured: Up to Week 96
Part C: Time to Confirmed Disability Progression (CDP)
Measured: Up to Week 24
Part C: Time to Confirmed Disability Improvement (CDI)
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study start1 Jul 2026
- Primary completion1 Jan 2030 (estimated)
- Study completion30 Jun 2033 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 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
- NCT07220252
- Sponsor's protocol ID
- TG1101-RMS-PED304
- Other IDs
- 2025-522257-19-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
- ClinicalTrials.gov ID
- NCT07220252
- Acronym / sponsor ID
- TG1101-RMS-PED304
- Conditions
- Relapsing Multiple Sclerosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 23 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 primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: Ublituximab | Experimental | Drug: UblituximabNew Regimen |
| Part B: Ublituximab | Experimental | Drug: UblituximabNew Regimen |
| Part B: Placebo | Placebo comparator | Drug: Placebo |
| Part B: Fingolimod | Experimental | Drug: Fingolimod |
| Part B: IV Placebo | Placebo comparator | Drug: Placebo |
| Part C: OLE | Experimental | Drug: Ublituximab |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of RMS.
- EDSS at screening: 0-5.5, inclusive.
- Neurologic stability for ≥ 30 days prior to screening, and between screening and Week 1 Day 1 (W1D1).
- 1. Participants must have completed Part A (Week 24 visit) or Part B (Week 96 visit) to be eligible for Part C.
Key exclusion criteria (11 listed)
- Known presence or suspicion of other neurologic disorders that may mimic MS.
- Prior treatments:
- Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time.
- The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics.
- 1. If the absolute lymphocyte count (ALC) is outside the specified range the participant will not be eligible to receive ublituximab in Part C.
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-1101, BRIUMVIAdministered as an intravenous (IV) infusion. | Drug | Part A: Ublituximab, Part B: Ublituximab, Part C: OLE |
| PlaceboOral capsule. | Drug | Part B: Placebo |
| PlaceboIV infusion. | Drug | Part B: IV Placebo |
| FingolimodOral capsule. | Drug | Part B: Fingolimod |
Primary outcome
Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab
Time frame: Predose and multiple timepoints up to Week 24
Part A: Maximum Observed Concentration (Cmax) of Ublituximab
Time frame: Day 1 and Day 15
Part A: Participant B Cell Counts
Time frame: Up to Week 24
Part B: Annualized Relapse Rate (ARR)
Time frame: Up to 96 weeks
Part C: Annualized Relapse Rate (ARR)
Time frame: Up to 168 weeks
13 secondary outcomes
Part A, B and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks
Part A, B and C: Number of Participants With Change in Columbia-Suicide Severity Rating Scale (C-SSRS )
Time frame: Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks
Part A: Serum Concentrations of Ublituximab
Time frame: Up to Week 24
Part A and B: Percentage of Participants with Treatment-emergent Anti-drug Antibodies (ADAs) to Ublituximab
Time frame: Part A: Up to Week 24; Part B: Up to 96 weeks
Part A and B: Number of Gadolinium Enhancing (Gd-enhancing) T1 Lesions per Magnetic Resonance Imaging (MRI) Scan
Time frame: Part A: Up to Week 24; Part B: Up to 96 weeks
Part A and B: Number of New and/or enlarging T2 Hyperintense Lesions (NELs) per MRI Scan
Time frame: Part A: Up to Week 24; Part B: Up to 96 weeks
Past A: Annualized Relapse Rate
Time frame: Up to Week 24
Part A and C: Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Time frame: Part A: Baseline, up to Week 24; Part C: Baseline, up to 168 weeks
Part B: Pharmacokinetics (PK) Serum Concentration of Ublituximab
Time frame: Up to Week 96
Part B: Percentage of Participants with CD19+ B cell counts ≤10 cells/uL
Time frame: Up to 96 weeks
Part B: Annualized Relapse Rate ARR
Time frame: Up to Week 96
Part C: Time to Confirmed Disability Progression (CDP)
Time frame: Up to Week 24
Part C: Time to Confirmed Disability Improvement (CDI)
Time frame: Up to Week 24
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 29 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.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ublituximab and Fingolimod in people with Relapsing Multiple Sclerosis, run by TG Therapeutics, Inc. at 6 sites in 3 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 11 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: looking for participants now, as of the sponsor's last update on 29 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 6 sites in Poland, United States, Slovakia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact TG Therapeutics Clinical Support Team (1-877-575-8489, clinicalsupport@tgtxinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab (time frame: Predose and multiple timepoints up to Week 24). The study lists 5 primary outcomes in all. 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 29 Oct 2026.