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 3 sites in Poland.
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
- 3 sitesPoland
- Study dates
- 1 Jul 2026to 30 Jun 2033
- Phase
- Phase 2/3
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
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland3 sites, 3 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
Warsaw, 04-730
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.
- 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
- Sep 2026
- First submitted
- 22 Oct 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No