Not Yet RecruitingPhase 2/3

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

240 participantsStarted 2026-06-01

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 range10 Years – 17 Years

SexALL

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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).
✕. 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.
✕. Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time.
✕. The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics.

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