Ocrelizumab vs Fingolimod for Pediatric Multiple Sclerosis
(Operetta 2 Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
This trial is for children and adolescents aged 10 to under 18 with relapsing-remitting multiple sclerosis (RRMS). They must weigh at least 50 kg, have had recent MS activity, and be neurologically stable. It's not for those with other neurological conditions that look like MS, uncontrolled diseases, active infections, or severe heart issues.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Fingolimod
- Ocrelizumab
Fingolimod is already approved in European Union, United States, Canada for the following indications:
- Relapsing forms of multiple sclerosis
- Relapsing forms of multiple sclerosis
- Relapsing forms of multiple sclerosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
PPD DEVELOPMENT, LP
Industry Sponsor
David Simmons
PPD DEVELOPMENT, LP
Chief Executive Officer since 2012
BSc in Applied Science from Georgia Institute of Technology
Martina Flammer
PPD DEVELOPMENT, LP
Chief Medical Officer since 2024
MD
PPD
Industry Sponsor
Dr. Austin Smith
PPD
Chief Medical Officer since 2020
Doctor of Medicine from the Royal College of Surgeons in Ireland
David Simmons
PPD
Chief Executive Officer since 2012
Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University