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A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)
A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)

NCT05123703

Active Not RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Relapsing-remitting Multiple Sclerosis

Interventions: Ocrelizumab, Ocrelizumab Placebo, Fingolimod, Fingolimod Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Estonia

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.

Eligibility overview

Sex: ALL

Age: 10 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

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 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
Locations (71)
  • La Jolla, California, United States
  • Aurora, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • San Miguel de Tucumán, Argentina
  • Parkville, Victoria, Australia
  • Vienna, Austria
  • Ghent, Belgium
  • Brasília, Federal District, Brazil
  • Curitiba, Paraná, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, Brazil
  • Ottawa, Ontario, Canada
  • Toronto, Ontario, Canada
  • Tallinn, Estonia
  • Tartu, Estonia
  • Bron, Rhône, France
  • Le Kremlin-Bicêtre, France
  • Montpellier, France
  • Strasbourg, France
  • Datteln, Germany
  • Dresden, Germany
  • + 41 more on CT.gov