Evaluating Ozanimod versus Fingolimod for Children with Relapsing Remitting Multiple Sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness and safety of ozanimod compared to fingolimod in treating children and adolescents diagnosed with relapsing remitting multiple sclerosis (RRMS). Participants will receive either ozanimod, fingolimod, or a placebo, and the study will monitor drug levels, effects, and tolerability. The research focuses on individuals who have experienced recent disease activity, ensuring a targeted approach to treatment evaluation.

Why it matters

Who can join: the full rules

Inclusion 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:

  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.

Exclusion Criteria:

* 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.

Where it's running

• University of California Davis Health
  Sacramento, California, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• University of Louisville, Norton Children's Research Institute
  Louisville, Kentucky, United States Recruiting
• Medical College of Wisconsin
  Milwaukee, Wisconsin, United States Recruiting
• Royal Children's Hospital
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Slip-and-trip motor training to reduce falls in relapsing‑remitting multiple sclerosis

  This program tests whether repeated practice with controlled slips and trips helps ambulatory adults with relapsing‑remitting multiple sclerosis learn to react better and lower their chance of falling.

  Recruiting Georgia State University · Atlanta, Georgia · NCT06919900

• Effects of Ketogenic Diet on Multiple Sclerosis

  This study is testing whether a ketogenic diet or a Mediterranean diet can help people with relapsing-remitting multiple sclerosis feel better and manage their symptoms.

  Recruiting IRCCS National Neurological Institute "C. Mondino" Foundation · Pavia · NCT06715436

• Using magnetic stimulation to reduce fatigue in multiple sclerosis

  This study is testing if a type of magnetic stimulation can help reduce fatigue in people with Relapsing-Remitting Multiple Sclerosis.

  Recruiting Danish Research Centre for Magnetic Resonance · Hvidovre, Capital Region · NCT06569550

• Treatment for Multiple Sclerosis Using Stem Cell Transplantation

  This study is testing the long-term effects of a stem cell treatment for people with active relapsing-remitting multiple sclerosis to see how it impacts their health over five years.

  Recruiting at 2 sites Amsterdam UMC, location VUmc · Amsterdam and 1 other locations · NCT06567197

• Observational study of patients with Multiple Sclerosis in Switzerland

  This study is trying to find out more about the early signs of Multiple Sclerosis and how it changes over time by looking at health data from patients in Switzerland.

  Recruiting University Hospital, Basel, Switzerland · Basel · NCT06526364

• Brief low-oxygen breathing to boost nerve plasticity and arm strength in MS

  This will see if brief bouts of low-oxygen breathing (acute intermittent hypoxia) can quickly improve arm and hand strength and nerve signaling in people with relapsing-remitting MS who have arm weakness.

  Recruiting Shirley Ryan AbilityLab · Chicago, Illinois · NCT06390930

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.