Relapsing-Remitting Multiple Sclerosis
Conditions
Keywords
pediatric Multiple Sclerosis, pediatric MS, children MS, children Multiple Sclerosis, pediatric ocrelizumab
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.
Interventions
DRUGOcrelizumab
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.
OTHEROcrelizumab Placebo
Ocrelizumab matching placebo will be administered by IV infusion on Day 1 and Day 15 and Q24W thereafter.
DRUGFingolimod
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).
OTHERFingolimod Placebo
Fingolimod matching placebo will be administered daily as a capsule.
Sponsors
Hoffmann-La Roche
PPD Development, LP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized Relapse Rate (ARR) | Baseline up to approximately 4 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Estonia, France, Germany, Greece, Hungary, India, Italy, Latvia, Mexico, Morocco, Poland, Portugal, Romania, Serbia, Spain, Switzerland, Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed