NCT06408259

Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	Ozanimod	Specified dose on specified days
DRUG	Fingolimod	Specified dose on specified days
OTHER	Placebo	Specified dose on specified days

Timeline

• Start date: 2025-04-08
• Primary completion: 2031-04-11
• Completion: 2036-07-13
• First posted: 2024-05-10
• Last updated: 2026-02-05

Locations

33 sites across 11 countries: United States, Australia, Italy, Mexico, Poland, Portugal, Puerto Rico, Romania, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study