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Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

StatusRecruiting
PhasePhase 3
Started2025-04-08
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
Study Status, Contacts/Locations v21
Study sites33 entries, revised
UniwersyteckiLocal SzpitalInstitution Kliniczny- w Poznaniu0108
2026-04-23
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v20
Sponsor changed: Celgene → Bristol-Myers Squibb+13 characters
WasCelgene
NowBristol-Myers Squibb
Study sites33 entries, revised
LocalUniversity Institutionof -Louisville, 0047Norton Children's Research Institute
2026-02-03
Study Status, Contacts/Locations, IPDSharing v19
Study sites33 entries, revised
LocalUniversity Institutionof -California 0130Davis Health LocalUniversity Institutionof -Chicago 0055Medical Center LocalMedical InstitutionCollege -of 0033Wisconsin
2026-01-08
Study Status, Contacts/Locations v18
Study sites32→33
2025-12-10
Study Status, Contacts/Locations v17
Study sites32 entries, revised
LocalOndokuz InstitutionMayıs - 0109Universitesi
Show 16 earlier versions
2025-12-01
Study Status, Contacts/Locations v16
Study sites31→32
2025-11-19
Study Status, Contacts/Locations v15
Study sites35→31
2025-11-05
Study Status, Contacts/Locations v14
Study sites35 entries, revised
Royal Children's Hospital Unidade Local Institutionde -Saúde 0113 Centrode HospitalarCoimbra, E Universitário De Coimbra.P.E.
2025-10-07
Study Status, Contacts/Locations v13
Study sitesdetails revised at 1 of 35 sites
2025-08-25
Study Status, Contacts/Locations v12
Study sites34→35
2025-07-22
Study Status, Contacts/Locations v11
Study sitesdetails revised at 2 of 34 sites
2025-07-02
Study Status, Contacts/Locations v10
Study sites34 entries, revised
LocalCentro InstitutionHospitalar -de 0104Lisboa Central
2025-06-19
Study Status, Contacts/Locations v9
Study sites31→34
2025-05-27
Study Status, Contacts/Locations v8
Study sites31 entries, revised
LocalUniversity Institutionof -South 0053Florida LocalCentro InstitutionHospitalar -E 0105Universitário De Coimbra
2025-05-02
Study Status, Contacts/Locations v7
Start dateestimated 2025-04-25→confirmed 2025-04-08
Study sites17→31
2025-04-07
Study Status, Contacts/Locations v6
Start date2025-03-31→2025-04-25
Study sites15→17
2025-03-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, References v5
Trial statusNot Yet Recruiting→Recruiting
Start date2025-02-15→2025-03-31
Study sites12→15
2025-02-12
Study Status, Contacts/Locations, References v4
Start date2025-01-28→2025-02-15
Study sites9→12
2024-11-27
Study Status, Contacts/Locations v3
Study sites8→9
2024-11-05
Study Status, Contacts/Locations v2
Start date2024-11-28→2025-01-28
Study sites7→8
2024-10-21
Study Status, Contacts/Locations, References v1
Start date2024-07-09→2024-11-28
Study sites5→7
2024-05-06
Original filing
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).
Trial Details
NCT Number NCT06408259
Lead Sponsor Bristol-Myers Squibb
Conditions Multiple Sclerosis, Relapsing-Remitting
Enrollment 194 participants
Start Date 2025-04-08
Primary Completion 2031-04-11 (estimated)
Study Completion 2036-07-13 (estimated)
Updated on ClinicalTrials.gov 2026-09-10