Running, not recruitingPhase 3Relapsing MSNCT051237032023-506516-40-002020-004128-41

What it found

Still running

No result yet.

What was tested

Treatment tested

Compared with

Placebo or sham

  • Ocrelizumab Placebo
  • Fingolimod Placebo
  • Placebo for FINGOLIMOD
  • Placebo for Ocrelizumab

Results by group

Protocol-defined Annualized Relapse Rate (ARR)

Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)

GroupValueIntervalNumber analysed
Ocrelizumab0.070 relapses per patient-year0.034–0.14493
Fingolimod0.135 relapses per patient-year0.075–0.24394

Ocrelizumab

0.07

Fingolimod

0.135

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Ocrelizumab936 (6.5%)0
Fingolimod928 (8.7%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Protocol-defined Annualized Relapse Rate (ARR)

    Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)

    Disability progressionRelapses

Other measures (16)

  • Protocol-defined ARR

    Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)

    Disability progressionRelapses
  • Number of New or Enlarging T2-hyperintense Lesions (T2 Lesions), as Detected by Brain Magnetic Resonance Imaging (MRI)

    Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)

    MRI lesions
  • Number of T1 Gd Lesions at Week 12

    At Week 12

    MRI lesions
  • Number of Participants With Adverse Events (AEs)

    Up to approximately 7 years

    Safety
  • Maximum Serum Concentration (Cmax) of Ocrelizumab

    Cycle (1 Cycle=24 weeks)

    How the body handles the medicine
  • Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC Tau) of Ocrelizumab

    Cycle 1 (1 Cycle=24 weeks)

    How the body handles the medicine
  • Number of Participants With Anti-drug Antibodies (ADAs) to Ocrelizumab

    Up to approximately 7 years

    Immune response
  • Levels of Cluster of Differentiation 19 (CD19) + B-cell Count in Blood

    Up to approximately 7 years

    Immune response
  • 3. Protocol-defined ARR during the double-blind period (superiority)

    Relapses
  • 4. 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)

    Safety

Who could take part

Relapsing MS · 10 to 17

Inclusion Criteria: * Body weight ≥ 25 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 prior to randomization Inclusion Criteria for Optional OLE Period: -Participants in Group A (ocrelizumab in the 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) Exclusion Criteria for Optional OLE Period: -Participants who have discontinued the study during the DBP

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      May 2022

    2. Main results due

      Jun 2025

    3. Finished

      Sept 2029

    4. Results posted

      Jul 2026

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