A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)
Phase 3
Active, not recruiting
NCT05123703
| Condition | Relapsing-remitting Multiple Sclerosis |
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| Phase | Phase 3 |
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| Sponsor | Hoffmann-La Roche |
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| Status | Active, not recruiting |
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| Enrollment | 188 participants |
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| Interventions | Ocrelizumab, Ocrelizumab Placebo, Fingolimod, Fingolimod Placebo |
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| Start date | May 19, 2022 |
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| Completion date | Jun 9, 2025 |
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| Results posted | Jul 15, 2026 |
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Summary
This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and \< 18 years over a flexible duration. The double-blind period will last until after the last participant randomized has completed 24 weeks.
Protocol-defined Annualized Relapse Rate (ARR)
Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks) · relapses per patient-year
| Ocrelizumab | 0.070 relapses per patient-year |
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| Fingolimod | 0.135 relapses per patient-year |
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| Adjusted Rate Ratio | 0.517 (95% CI 0.193–1.329) |
Open in BENITIONS
View on ClinicalTrials.gov
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