Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More TG Therapeutics, Inc. trials in the USA
Other trials for the same condition
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