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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Relapsing Multiple Sclerosis

In brief

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).

Key facts

Study ID

NCT07220252

Run by

TG Therapeutics, Inc.

People needed

240

Starts

2026-07-01

Expected to finish

2033-06-30

Last updated by the study team

2026-07-17

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

Where it is running

• TG Therapeutics Investigational Trial Site — Gdansk, Poland (enrolling)
• TG Therapeutics Investigational Trial Site — Poznan, Poland

Full record on ClinicalTrials.gov

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