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A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis
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.
Study 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 10 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-02-04
Primary completion: 2025-07-07
Study completion finish: 2029-09-17
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05123703
Intervention or treatment
DRUG: Ocrelizumab
OTHER: Ocrelizumab Placebo
DRUG: Fingolimod
OTHER: Fingolimod Placebo
Conditions
- • Relapsing-Remitting Multiple Sclerosis
Find a site
Closest Location:
Royal Children's Hospital Melbourne - PIN
Research sites nearby
Select from list below to view details:
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Ocrelizumab
| DRUG: Ocrelizumab
|
ACTIVE_COMPARATOR: Fingolimod
| OTHER: Ocrelizumab Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Annualized relapse rate (ARR) | Not Specified | Baseline up to approximately 4 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Number of new or enlarging T2-hyperintense lesions (T2 lesions) as detected by brain MRI during the double-blind period | Not Specified | Baseline up to approximately 4 years |
Number of new or enlarging T2 lesions by Week 96 | Not Specified | Baseline up to Week 96 |
Annualized relapse rate (ARR) by Week 96 | Not Specified | Baseline up to Week 96 |
Number of T1 Gd lesions at Week 12 | Not Specified | Week 12 |
Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) | Not Specified | Baseline up to approximately 8 years |
Prevalence of ADAs at baseline and incidence of ADAs during the study | Not Specified | Baseline up to approximately 8 years |
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