A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Relapsing-remitting Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT05123703
- Run by
- Hoffmann-La Roche
- People needed
- 188
- Starts
- 2022-05-19
- Expected to finish
- 2029-09-17
- Last updated by the study team
- 2026-07-15
Who can join
Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Body weight ≥ 25 kg
- Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric multiple sclerosis (MS), Version 2012, or McDonald criteria 2017
- Expanded Disability Status Scale (EDSS) at screening: 0-5.5, inclusive
- For all countries except Germany, 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 prior to randomization
- Inclusion Criteria for Optional OLE Period:
- Participants in Group A (ocrelizumab in the DBP) and Group B (fingolimod in the DBP) who, in the opinion of the investigator, may benefit from switching to ocrelizumab and who have completed the DBP with study treatment (ocrelizumab/fingolimod), may participate in the OLE period
You may not qualify if…
- 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 participant from participating in the study
- Participants with severe cardiac disease or significant findings on the screening electrocardiograph (ECG)
- Exclusion Criteria for Optional OLE Period:
- Participants who have discontinued the study during the DBP
Where it is running
- Children's Hospital Colorado — Aurora, Colorado, United States
- Children's National Hospital — Washington D.C., District of Columbia, United States
- Johns Hopkins Medicine — Baltimore, Maryland, United States
- Boston Children's Hospital Central Pharmacy — Boston, Massachusetts, United States
- Washington University — St Louis, Missouri, United States
- Cleveland Clinic, Mellen Center for Multiple Sclerosis — Cleveland, Ohio, United States
- The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company — Columbus, Ohio, United States
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Baylor College of Medicine/Texas Children's Hospital — Houston, Texas, United States
- Centro de Investigaciones Médicas Tucuman — San Miguel de Tucumán, Argentina
- Royal Children's Hospital Melbourne - PIN — Parkville, Victoria, Australia
- Medizinische Universität Wien — Vienna, Austria
- UZ Gent — Ghent, Belgium
- L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME — Brasília, Federal District, Brazil
- Instituto de Neurologia de Curitiba — Curitiba, Paraná, Brazil
- Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR — Porto Alegre, Rio Grande do Sul, Brazil
- Hospital Sao Lucas - PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
- CPQuali Pesquisa Clínica Sao Paulo — São Paulo, São Paulo, Brazil
- Inst. Da Criança- Faculdade de Medicina Usp — São Paulo, Brazil
- Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada
- The Hospital for Sick Children — Toronto, Ontario, Canada
- Astra Kliinik — Tallinn, Estonia
- Tartu University Hospital — Tartu, Estonia
- Hospices Civils de Lyon - Hôpital Pierre Wertheimer — Bron, Rhône, France
- UC San Diego — La Jolla, California, United States
Full record on ClinicalTrials.gov
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