RecruitingPhase 2/3

Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis

Poland240 participantsStarted 2026-07-01

Plain-language 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 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).

Who can participate

Age range

10 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

Exclusion criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab

Timeframe: Predose and multiple timepoints up to Week 24

Part A: Maximum Observed Concentration (Cmax) of Ublituximab

Timeframe: Day 1 and Day 15

Part A: Participant B Cell Counts

Timeframe: Up to Week 24

Part B: Annualized Relapse Rate (ARR)

Timeframe: Up to 96 weeks

Part C: Annualized Relapse Rate (ARR)

Timeframe: Up to 168 weeks

Trial details

NCT IDNCT07220252

SponsorTG Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-01-01

Contact for this trial

TG Therapeutics Clinical Support Team

1-877-575-8489 clinicalsupport@tgtxinc.com

View on ClinicalTrials.gov More Relapsing Multiple Sclerosis trials