NCT06408259RecruitingPhase 3
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
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
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 194 (estimated)
- First submitted
- 25 Apr 2024
- Start date
- 8 Apr 2025
- Primary completion date
- 11 Apr 2031
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Multiple sclerosis
- NCT number
- NCT06408259
- EU CT number
- 2022-501332-42-00
- EudraCT number
- 2022-501332-42
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 194
- From 8 Apr 2025 to the primary completion date, 11 Apr 2031
- 33 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active or chronic disease of the immune system other than MS.
- Clinically relevant cardiovascular, hepatic, neurological other major systematic disease.
Other
- Diagnosis of progressive forms of MS.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- 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:
- At least 1 MS relapse/attack in the previous year prior to screening.
- At least 2 MS relapses/attacks in the previous 2 years prior to screening.
- 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.
Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (33)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Children's Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Sant Joan De Deu Barcelona Hospital Coordinator of this site? Confirm its status | Esplugues De Llobregat | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Recruiting |
| Hospital Unviersitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Neurological Centre Of Latium Istituto Di Neuroscienze O In Breve N.C.L. Istituto Di Neuroscienze S.r.l. Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Local Institution - 0078 Coordinator of this site? Confirm its status | Mexico City | Mexico | Withdrawn |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Local Institution - 0134 Coordinator of this site? Confirm its status | Caguas | Puerto Rico | Not yet recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Recruiting |
| Unidade Local de Saúde de Coimbra, E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
| Unidade Local De Saude De Sao Jose E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local de Saude de Sao Joao E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Dr. Victor Gomoiu Clinical Children Hospital Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Local Institution - 0093 Coordinator of this site? Confirm its status | Chicago | United States | Withdrawn |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Local Institution - 0091 Coordinator of this site? Confirm its status | Cincinnati | United States | Withdrawn |
| Local Institution - 0133 Coordinator of this site? Confirm its status | El Paso | United States | Not yet recruiting |
| Local Institution - 0114 Coordinator of this site? Confirm its status | Loma Linda | United States | Not yet recruiting |
| University of Louisville, Norton Children's Research Institute Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Local Institution - 0131 Coordinator of this site? Confirm its status | New Brunswick | United States | Not yet recruiting |
| Local Institution - 0092 Coordinator of this site? Confirm its status | Portland | United States | Not yet recruiting |
| University of California Davis Health Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Local Institution - 0132 Coordinator of this site? Confirm its status | Teaneck | United States | Withdrawn |
| Ondokuz Mayıs Universitesi Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.