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NOT YET RECRUITING
NCT07220252
PHASE2/PHASE3

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

Sponsor: TG Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

Ublituximab

Administered as an intravenous (IV) infusion.

DRUG

Placebo

Oral capsule.

DRUG

Placebo

IV infusion.

DRUG

Fingolimod

Oral capsule.