NCT06408259 Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
| NCT ID | NCT06408259 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Multiple Sclerosis, Relapsing-Remitting |
| Study Type | INTERVENTIONAL |
| Enrollment | 194 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2031-04-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 194 participants in total. It began in 2025-04-08 with a primary completion date of 2031-04-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT06408259 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 17 Years, studying Multiple Sclerosis, Relapsing-Remitting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06408259 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 194 participants.
Is NCT06408259 currently recruiting?
Yes, NCT06408259 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT06408259 trial being conducted?
This trial is being conducted at Loma Linda, United States, Sacramento, United States, Tampa, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT06408259 clinical trial?
NCT06408259 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 194 participants.
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