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
2026-07-01
Completion Date
2033-06-30
Last Updated
2026-08-21
Healthy Volunteers
No
Conditions
Interventions
Ublituximab
Administered as an intravenous (IV) infusion.
Placebo
Oral capsule.
Placebo
IV infusion.
Fingolimod
Oral capsule.
Locations (2)
TG Therapeutics Investigational Trial Site
Gdansk, Poland
TG Therapeutics Investigational Trial Site
Poznan, Poland