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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

PHASE3RECRUITING

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.

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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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Body weight ≥ 40 kg
  • Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017
  • EDSS at screening: 0-5.5, inclusive
  • Neurologic stability for ≥ 30 days prior to screening, and between screening and Day 1
  • 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
  • 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 patient from participating in the study
  • Patient with severe cardiac disease or significant findings on the screening ECG
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    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

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    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

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    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/ArmIntervention/Treatment
    EXPERIMENTAL: Ocrelizumab
    • Participants will receive Ocrelizumab by IV infusion every 24 weeks. 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 every 24 weeks. Participants will also receive a placebo of fingolimod (administered as QD capsule).
    DRUG: Ocrelizumab
    • Ocrelizumab will be administered at a dose of 600 mg by IV infusion on Day 1 and Day 15 (half the dose, 2 weeks apart) and every 24 weeks thereafter.
    ACTIVE_COMPARATOR: Fingolimod
    • Participants will receive Fingolimod PO QD as per the prescribing information provided with fingolimod. Patients will also receive a placebo of ocrelizumab (administered as IV infusions on Days 1 and 15, and every 24 weeks thereafter).
    OTHER: Ocrelizumab Placebo
    • Ocrelizumab placebo will be administered by IV infusion on day 1 and Day 15 and every 24 weeks thereafter.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Annualized relapse rate (ARR)Not SpecifiedBaseline up to approximately 4 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Number of new or enlarging T2-hyperintense lesions (T2 lesions) as detected by brain MRI during the double-blind periodNot SpecifiedBaseline up to approximately 4 years
    Number of new or enlarging T2 lesions by Week 96Not SpecifiedBaseline up to Week 96
    Annualized relapse rate (ARR) by Week 96Not SpecifiedBaseline up to Week 96
    Number of T1 Gd lesions at Week 12Not SpecifiedWeek 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 SpecifiedBaseline up to approximately 8 years
    Prevalence of ADAs at baseline and incidence of ADAs during the studyNot SpecifiedBaseline up to approximately 8 years

    Frequently Asked Questions

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    References

    Clinical Trials Gov: A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis

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