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Recruiting Phase 2/3

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

NCT07220252 · tracked via the Priya Life Science USA tracker
Phase
Phase 2/3
Started
2026-07-01
Last updated
2026-10-29

Condition(s) studied

Relapsing Multiple Sclerosis

Investigational drug(s) / intervention(s)

Ublituximab →PlaceboPlaceboFingolimod →

Ublituximab: Administered as an intravenous (IV) infusion.

Placebo: Oral capsule.

Placebo: IV infusion.

Fingolimod: Oral capsule.

Study 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).

Eligibility

Sex
ALL
Min age
10 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria for Part A and Part B: 1. Diagnosis of RMS. 2. EDSS at screening: 0-5.5, inclusive. 3. Neurologic stability for ≥ 30 days prior to screening, and between screening and Week 1 Day 1 (W1D1). Inclusion Criteria for Part C: 1\. Participants must have completed Part A (Week 24 visit) or Part B (Week 96 visit) to be eligible for Part C. Exclusion Criteria for Part A and B: 1. Known presence or suspicion of other neurologic disorders that may mimic MS. 2. Prior treatments: 1. 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). 2. High dose intravenous immunoglobulin (IVIG) or subcutaneous IG (SCIG) within 2 months prior to W1D1. 3. Treatment with anti-CD20 or other B cell directed treatment at any time. 4. Treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone at any time. Additional Exclusion Criteria for Part B Only (Relevant to Fingolimod Treatment): 1. Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time. 2. The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics. Exclusion Criteria for Part C: 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

Primary outcome measure(s)

  • Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab — Predose and multiple timepoints up to Week 24
  • Part A: Maximum Observed Concentration (Cmax) of Ublituximab — Day 1 and Day 15
  • Part A: Participant B Cell Counts — Up to Week 24
  • Part B: Annualized Relapse Rate (ARR) — Up to 96 weeks
  • Part C: Annualized Relapse Rate (ARR) — Up to 168 weeks

Trial sites (6)

FacilityCityRegionStatus
TG Therapeutics Investigational Trial Site Salt Lake City Utah Recruiting
TG Therapeutics Investigational Trial Site Gdansk Poland Recruiting
TG Therapeutics Investigational Trial Site Poznan Poland Not Yet Recruiting
TG Therapeutics Investigational Trial Site Rzeszów Poland Recruiting
TG Therapeutics Investigational Trial Site Warsaw Poland Recruiting
TG Therapeutics Investigational Trial Site Bratislava Slovakia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07220252 on ClinicalTrials.gov ↗ ← All trials in the USA