Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
Recruiting · NCT06408259 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
10 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
33 locations listed across 9 US states.
- Local Institution - 0114 - Loma Linda, California, United States
- University of California Davis Health - Sacramento, California, United States
- University of South Florida - Tampa, Florida, United States
- Local Institution - 0093 - Chicago, Illinois, United States
- University of Chicago Medical Center - Chicago, Illinois, United States
- University of Louisville, Norton Children's Research Institute - Louisville, Kentucky, United States
- Local Institution - 0131 - New Brunswick, New Jersey, United States
- Local Institution - 0132 - Teaneck, New Jersey, United States
- Local Institution - 0091 - Cincinnati, Ohio, United States
- Local Institution - 0092 - Portland, Oregon, United States
- Local Institution - 0133 - El Paso, Texas, United States
- Medical College of Wisconsin - Milwaukee, Wisconsin, United States
- 2Ca Braga - Braga, Portugal
- Local Institution - 0134 - Caguas, Puerto Rico
- Unidade Local de Saúde de Coimbra, E.P.E. - Coimbra, Portugal
- Centro Hospitalar de Lisboa Central - Lisbon, Portugal
- Local Institution - 0102 - Porto, Portugal
- Ondokuz Mayıs Universitesi - Samsun, Turkey (Türkiye)
- Hospital Universitario Virgen Macarena - Seville, Spain
- National Taiwan University Hospital - Taipei, Taiwan
- Hospital Universitari i Politecnic La Fe - Valencia, Spain
- Hospital Universitario Miguel Servet - Zaragoza, Spain
- Local Institution - 0096 - Esplugues de Llobregat, Barcelona [Barcelona], Spain
- Spitalul Clinic de Copii Doctor Victor Gomoiu - Bucharest, Bucharest, Romania
- Prof. Dr. Alexandru Obregia Psychiatry Hospital - Bucharest, Bucharest, Romania
- University of Naples Federico II - Naples, Campania, Italy
- Local Institution - 0078 - Mexico City, DIF, Mexico
- Local Institution - 0108 - Poznan, Greater Poland Voivodeship, Poland
- Ospedale San Raffaele - Milan, Lombardy, Italy
- Local Institution - 0081 - Milan, Lombardy, Italy
- CHUVI- Hospital Alvaro Cunqueiro - Vigo, Pontevedra [Pontevedra], Spain
- Neurological Center Of Latium - Rome, Roma, Italy
- Royal Children's Hospital - Melbourne, Victoria, Australia