RECRUITING

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

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).

Conditions

Multiple Sclerosis, Relapsing-Remitting
Talk to us

Related Conditions:

Multiple Sclerosis, Relapsing-Remitting

Study Overview

On this page

Study Details

Study overview

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).

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

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

Condition
Multiple Sclerosis, Relapsing-Remitting
Intervention / Treatment

-

Contacts and Locations

Sacramento

Local Institution - 0130, Sacramento, California, United States, 95817

San Francisco

UCSF Benioff Children's Hospital San Francisco, San Francisco, California, United States, 94158

Tampa

Axiom Clinical Research of Florida, Tampa, Florida, United States, 33609

Tampa

University of South Florida, Tampa, Florida, United States, 33612

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

Milwaukee

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease.
  • * Meets at least 1 of the following criteria for disease activity:
  • * Diagnosis of progressive forms of MS.
  • * Active or chronic disease of the immune system other than MS.
  • * Clinically relevant cardiovascular, hepatic, neurological other major systematic disease.
  • * Other protocol-defined Inclusion/Exclusion criteria apply.

Ages Eligible for Study

10 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Celgene,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2036-07-13