A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis

• Status: Not yet recruiting
• Trial end date: 2029-11-05
• Target enrollment: 0
• Participant gender: All

Summary

This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: PPD
• Treatments: Fingolimod Hydrochloride; Ocrelizumab

Criteria

Inclusion Criteria:

• Body weight ≥ 50 kg

• Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017

• EDSS at screening: 0-5.5, inclusive

• Neurologic stability for ≥ 30 days prior to screening, and between screening and Day 1

• At least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 months

Exclusion Criteria:

• Known presence or suspicion of other neurologic disorders that may mimic MS

• Significant uncontrolled somatic diseases, known active infection or any other significant condition that may preclude patient from participating in the study

• Patient with severe cardiac disease or significant findings on the screening ECG