clinical trial · NCT07220252
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
Relapsing Multiple SclerosisUblituximabPlaceboPlaceboFingolimod
brief 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).
started
Jun 1, 2026
primary completion
Jan 1, 2030
completion
Jun 30, 2033
last updated
May 12, 2026
official title
Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol