NCT07220252

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)

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: TG Therapeutics, Inc. · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Ublituximab	Administered as an intravenous (IV) infusion.
DRUG	Placebo	Oral capsule.
DRUG	Placebo	IV infusion.
DRUG	Fingolimod	Oral capsule.

Timeline

• Start date: 2026-06-01
• Primary completion: 2030-01-01
• Completion: 2033-06-30
• First posted: 2025-10-23
• Last updated: 2026-04-03

Regulatory

• FDA-regulated drug study