Summary

Eligibility
for people ages 10-17 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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).

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

Keywords

Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Relapsing-Remitting, Ozanimod, Zeposia®, Relapsing-Remitting Multiple Sclerosis, Sclerosis, Fingolimod Hydrochloride, Fingolimod

Eligibility

You can join if…

Open to people ages 10-17

  • 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:

    i) At least 1 MS relapse/attack in the previous year prior to screening.

    ii) At least 2 MS relapses/attacks in the previous 2 years prior to screening. iii) Evidence of 1 or more gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) within 6 months prior to baseline (including screening MRI). - Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive.

You CAN'T join if...

  • 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.

Locations

  • UCSF Benioff Children's Hospital San Francisco
    San Francisco California 94158 United States
  • Washington University
    Saint Louis Missouri 63110 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls
ID
NCT06408259
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 194 study participants
Last Updated