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

a study on Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis

Summary

Eligibility
for people ages 10-17 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Details

This Phase III randomized, double-blind, double-dummy, multicenter study will evaluate the safety and efficacy of ocrelizumab administered by IV infusion every 24 weeks compared with fingolimod taken orally daily, in children and adolescents with Multiple Sclerosis aged between 10 and < 18 years. The study plans to enroll 233 patients in a 1:1 randomization (ocrelizumab:fingolimod), globally. This study consists of a double-blind, double dummy period in which patients will be treated with either active ocrelizumab or active fingolimod for at least 96 weeks. Patients who complete the double-blind period will be offered the possibility to enter an optional open-label extension treatment period of at least 144 weeks with ocrelizumab.

Keywords

Relapsing-Remitting Multiple Sclerosis, pediatric Multiple Sclerosis, pediatric MS, children MS, children Multiple Sclerosis, pediatric ocrelizumab, Multiple Sclerosis, Sclerosis, Ocrelizumab, Fingolimod Hydrochloride, Fingolimod

Eligibility

You can join if…

Open to people ages 10-17

  • Body weight ≥ 40 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

You CAN'T join 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 patient from participating in the study
  • Patient with severe cardiac disease or significant findings on the screening ECG

Locations

  • UC San Diego; ACTRI accepting new patients
    La Jolla California 92037 United States
  • University of California San Francisco in progress, not accepting new patients
    San Francisco California 94117 United States
  • Neurociencias Estudios Clinicos S.C. accepting new patients
    Culiacán Sinaloa 80020 Mexico

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT05123703
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 171 study participants
Last Updated
Contact us about this trial