A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Interventions
- Registration Number
- NCT05123703
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 171
- Body weight ≥ 25 kilograms (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
Inclusion Criteria for Optional OLE Period:
-Participants in Group A (ocrelizumab in the double-blind period [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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ocrelizumab Ocrelizumab Participants will receive ocrelizumab by intravenous (IV) infusion every 24 weeks (Q24W). The first dose is given as dual infusions of half the dose of ocrelizumab on Days 1 and 15 and subsequent doses are given as single infusions of ocrelizumab Q24W. Participants will also receive a placebo of fingolimod administered as once a day (QD) capsule. Ocrelizumab Fingolimod Placebo Participants will receive ocrelizumab by intravenous (IV) infusion every 24 weeks (Q24W). The first dose is given as dual infusions of half the dose of ocrelizumab on Days 1 and 15 and subsequent doses are given as single infusions of ocrelizumab Q24W. Participants will also receive a placebo of fingolimod administered as once a day (QD) capsule. Fingolimod Ocrelizumab Placebo Participants will receive fingolimod orally (PO) QD as per the prescribing information provided with fingolimod. Participants will also receive a placebo of ocrelizumab administered as IV infusion on Days 1 and 15, and Q24W thereafter. Fingolimod Fingolimod Participants will receive fingolimod orally (PO) QD as per the prescribing information provided with fingolimod. Participants will also receive a placebo of ocrelizumab administered as IV infusion on Days 1 and 15, and Q24W thereafter.
- Primary Outcome Measures
Name Time Method Annualized Relapse Rate (ARR) Baseline up to approximately 4 years
- Secondary Outcome Measures
Name Time Method Number of New or Enlarging T2-hyperintense Lesions (T2 lesions) as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-blind Period Baseline up to approximately 4 years Number of New or Enlarging T2 Lesions by Week 96 Baseline up to Week 96 ARR by Week 96 Baseline up to Week 96 Number of T1 Gadolinium (Gd) Lesions at Week 12 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) Baseline up to approximately 8 years Prevalence of Anti-drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study Baseline up to approximately 8 years
Trial Locations
- Locations (106)
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, District of Columbia, United States
Johns Hopkins Medicine
🇺🇸Baltimore, Maryland, United States
Pediatric Multiple Sclerosis and Related Disorders Program at Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Washington University, Pediatric MS and other Demyelinating Disease Center
🇺🇸Saint 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 MS
🇺🇸Columbus, Ohio, United States
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