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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

2026-07-01

Completion Date

2033-06-30

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

DRUG

Ublituximab

Administered as an intravenous (IV) infusion.

DRUG

Placebo

Oral capsule.

DRUG

Placebo

IV infusion.

DRUG

Fingolimod

Oral capsule.

Locations (1)

TG Therapeutics Investigational Trial Site

Poznan, Poland