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.
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 RRMS aged between 10 and \< 18 years. The study plans to enroll 171 participants in a 1:1 randomization (ocrelizumab:fingolimod), globally. This study consists of a double-blind, double dummy period in which participants will be treated with either active ocrelizumab or active fingolimod for a flexible duration. Participants who complete the double-blind period will be offered the possibility to enter an optional open-label extension (OLE) treatment period of at least 144 weeks with ocrelizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
188
Ocrelizumab 300 milligrams (mg) will be administered by IV infusion to participants who weigh \< 35 kilograms (kg) and ocrelizumab 600 mg IV will be administered to participants who weigh ≥ 35 kg on Days 1 and 15 (half the dose, 2 weeks apart) and Q24W thereafter.
Ocrelizumab matching placebo will be administered by IV infusion on Day 1 and Day 15 and Q24W thereafter.
Fingolimod will be administered daily as a capsule per the prescribing information (0.25 mg to participants who weigh ≤ 40 kg and 0.5 mg to participants who weigh \> 40 kg).
Annualized Relapse Rate (ARR)
Time frame: Baseline up to approximately 4 years
Number of New or Enlarging T2-hyperintense Lesions (T2 lesions) as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-blind Period
Time frame: Baseline up to approximately 4 years
Number of New or Enlarging T2 Lesions by Week 96
Time frame: Baseline up to Week 96
ARR by Week 96
Time frame: Baseline up to Week 96
Number of T1 Gadolinium (Gd) Lesions at Week 12
Time frame: Week 12
Incidence and Severity of Adverse Events (AEs), With Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Time frame: Baseline up to approximately 8 years
Prevalence of Anti-drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study
Time frame: Baseline up to approximately 8 years
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Fingolimod matching placebo will be administered daily as a capsule.
UC San Diego
La Jolla, California, United States
University of California San Francisco
San Francisco, California, United States
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
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 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
...and 92 more locations