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A Phase III Multicenter, Randomized, Double-blind, Double-dummy Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis

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Trial Profile

A Phase III Multicenter, Randomized, Double-blind, Double-dummy Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Sep 2026

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At a glance

  • Drugs Ocrelizumab (Primary) ; Dimenhydrinate; Fingolimod; Methylprednisolone
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms Operetta 2
  • Sponsors Roche

Most Recent Events

  • 18 Sep 2026 According to a Roche media release, based on results form this trial the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Ocrevus intravenous infusion for the treatment of paediatric patients aged 10 years and older with relapsing forms of multiple sclerosis (RMS). The U.S. FDA approved Ocrevus for paediatric RMS patients in May 2026. A final decision from the European Commission is expected in the near future.
  • 08 May 2026 According to a Genentech media release, U.S. FDA approved Ocrevus (ocrelizumab) for the treatment of relapsing-remitting multiple sclerosis (RRMS) in pediatric patients 10 years of age and older.
  • 08 May 2026 Results presented in the Genentech media release.

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