Overview

Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis

Status:
NOT_YET_RECRUITING

Trial end date:
2033-06-30

Target enrollment:

Participant gender:

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).

Phase:

PHASE2

Details

Lead Sponsor:

TG Therapeutics, Inc.

Treatments:

Fingolimod Hydrochloride
ublituximab