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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 (Operetta 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05123703
Recruitment Status : Recruiting
First Posted : November 17, 2021
Last Update Posted : May 16, 2023
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Drug: Ocrelizumab Other: Ocrelizumab Placebo Drug: Fingolimod Other: Fingolimod Placebo Phase 3

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 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis
Actual Study Start Date : February 4, 2022
Estimated Primary Completion Date : July 7, 2025
Estimated Study Completion Date : November 5, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/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.

Other: Fingolimod Placebo
Fingolimod placebo will be administsred daily as a capsule.
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.

Drug: Fingolimod
Fingolimod will be administered daily as 0.5 mg capsule.


Outcome Measures
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Primary Outcome Measures :
  1. Annualized relapse rate (ARR) [ Time Frame: Baseline up to approximately 4 years ]

Secondary Outcome Measures :
  1. Number of new or enlarging T2-hyperintense lesions (T2 lesions) as detected by brain MRI during the double-blind period [ Time Frame: Baseline up to approximately 4 years ]
  2. Number of new or enlarging T2 lesions by Week 96 [ Time Frame: Baseline up to Week 96 ]
  3. Annualized relapse rate (ARR) by Week 96 [ Time Frame: Baseline up to Week 96 ]
  4. Number of T1 Gd lesions at Week 12 [ Time Frame: Week 12 ]
  5. 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) [ Time Frame: Baseline up to approximately 8 years ]
  6. Prevalence of ADAs at baseline and incidence of ADAs during the study [ Time Frame: Baseline up to approximately 8 years ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body weight ≥ 50 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05123703


Contacts
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Contact: Reference Study ID Number: WN42086 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
PPD
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05123703    
Other Study ID Numbers: WN42086
2020-004128-41 ( EudraCT Number )
First Posted: November 17, 2021    Key Record Dates
Last Update Posted: May 16, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoffmann-La Roche:
pediatric Multiple Sclerosis
pediatric MS
children MS
children Multiple Sclerosis
pediatric ocrelizumab
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Ocrelizumab
Fingolimod Hydrochloride
Immunologic Factors
Physiological Effects of Drugs
Sphingosine 1 Phosphate Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents