Compares ozanimod and fingolimod in children with relapsing multiple sclerosis
Tests ozanimod against fingolimod in children and teens with relapsing multiple sclerosis.
Plain-language title generated from the registry record
Registry title: Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
Key facts
- Where
- Esplugues De Llobregat, Sevilla, Valencia, Vigo, and Zaragoza, SpainSee the 5 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 17 years old?
Source: NCT06408259, who can take part
Where in Spain
- Sant Joan De Deu Barcelona HospitalEsplugues De Llobregat, SpainTaking people
- Hospital Universitario Virgen De La MacarenaSevilla, SpainTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpainTaking people
- Hospital Alvaro CunqueiroVigo, SpainTaking people
- Hospital Unviersitario Miguel ServetZaragoza, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT06408259EU 2022-501332-42-00
- Record updated
- 10 September 2026
- Original 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).Read full original descriptionShow less
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
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).
Inclusion: 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.
Exclusion: Active or chronic disease of the immune system other than MS; Clinically relevant cardiovascular, hepatic, neurological other major systematic disease; Diagnosis of progressive forms of MS; Other protocol-defined Inclusion/Exclusion criteria apply.