RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-03-31
Study Completion:2036-07-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06408259

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease.
  2. * Meets at least 1 of the following criteria for disease activity:
  1. * Diagnosis of progressive forms of MS.
  2. * Active or chronic disease of the immune system other than MS.
  3. * Clinically relevant cardiovascular, hepatic, neurological other major systematic disease.
  4. * Other protocol-defined Inclusion/Exclusion criteria apply.

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0130
Sacramento, California, 95817
United States
UCSF Benioff Children's Hospital San Francisco
San Francisco, California, 94158
United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609
United States
University of South Florida
Tampa, Florida, 33612
United States
Washington University
Saint Louis, Missouri, 63110
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Celgene

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-31
Study Completion Date2036-07-13

Study Record Updates

Study Start Date2025-03-31
Study Completion Date2036-07-13

Terms related to this study

Keywords Provided by Researchers

  • Multiple Sclerosis
  • Relapsing-Remitting
  • Ozanimod
  • Zeposia®

Additional Relevant MeSH Terms

  • Multiple Sclerosis, Relapsing-Remitting