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

NCT06408259 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2026-04-28

No results posted yet for this study

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

DRUG

Ozanimod

Specified dose on specified days

DRUG

Fingolimod

Specified dose on specified days

OTHER

Placebo

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-08
Primary Completion
2031-04-11
Completion
2036-07-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Italy
  • Mexico
  • Poland
  • Portugal
  • Puerto Rico
  • Romania
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06408259 on ClinicalTrials.gov