Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
Sponsor: TG Therapeutics, Inc.
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).
Official title: Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
Key Details
Gender
All
Age Range
10 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-06-01
Completion Date
2033-06-30
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Ublituximab
Administered as an intravenous (IV) infusion.
Placebo
Oral capsule.
Placebo
IV infusion.
Fingolimod
Oral capsule.