RecruitingPhase 2Phase 3NCT07220252

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

Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)

Sponsor

TG Therapeutics, Inc.

Enrollment

240 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Relapsing Multiple Sclerosis

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).

Eligibility

Min Age: 10 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Fingolimod, a drug called Placebo, and others for people with relapsing multiple sclerosis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 10 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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