TG Therapeutics, Inc.
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).
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/…
Administered as an intravenous (IV) infusion.
Oral capsule.
IV infusion.
Oral capsule.