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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05123703




Registration number
NCT05123703
Ethics application status
Date submitted
16/11/2021
Date registered
17/11/2021
Date last updated
9/04/2025

Titles & IDs
Public title
A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)
Scientific 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
Secondary ID [1] 0 0
2020-004128-41
Secondary ID [2] 0 0
WN42086
Universal Trial Number (UTN)
Trial acronym
Operetta 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ocrelizumab
Other interventions - Ocrelizumab Placebo
Treatment: Drugs - Fingolimod
Other interventions - Fingolimod Placebo

Experimental: Ocrelizumab - Participants will receive ocrelizumab by intravenous (IV) infusion every 24 weeks (Q24W). 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 Q24W. Participants will also receive a placebo of fingolimod administered as once a day (QD) capsule.

Active comparator: Fingolimod - Participants will receive fingolimod orally (PO) QD as per the prescribing information provided with fingolimod. Participants will also receive a placebo of ocrelizumab administered as IV infusion on Days 1 and 15, and Q24W thereafter.


Treatment: Drugs: Ocrelizumab
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.

Other interventions: Ocrelizumab Placebo
Ocrelizumab matching placebo will be administered by IV infusion on Day 1 and Day 15 and Q24W thereafter.

Treatment: Drugs: Fingolimod
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).

Other interventions: Fingolimod Placebo
Fingolimod matching placebo will be administered daily as a capsule.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized Relapse Rate (ARR)
Timepoint [1] 0 0
Baseline up to approximately 4 years
Secondary outcome [1] 0 0
Number of New or Enlarging T2-hyperintense Lesions (T2 lesions) as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-blind Period
Timepoint [1] 0 0
Baseline up to approximately 4 years
Secondary outcome [2] 0 0
Number of New or Enlarging T2 Lesions by Week 96
Timepoint [2] 0 0
Baseline up to Week 96
Secondary outcome [3] 0 0
ARR by Week 96
Timepoint [3] 0 0
Baseline up to Week 96
Secondary outcome [4] 0 0
Number of T1 Gadolinium (Gd) Lesions at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
Baseline up to approximately 8 years
Secondary outcome [6] 0 0
Prevalence of Anti-drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study
Timepoint [6] 0 0
Baseline up to approximately 8 years

Eligibility
Key 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
Minimum age
10 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/09/2029
Actual
Sample size
Target
171
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital Melbourne - PIN - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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Colorado
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District of Columbia
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Maryland
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Massachusetts
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Missouri
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New Jersey
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Ohio
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Pennsylvania
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Texas
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United States of America
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Virginia
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Argentina
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Ciudad de Buenos Aires
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Argentina
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Cordoba
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Argentina
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San Miguel de Tucuman
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Austria
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Wien
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Belgium
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Brussel
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Belgium
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Bruxelles
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Belgium
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Gent
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Brazil
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Distrito Federal
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Brazil
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Paraná
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Brazil
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Rio Grande Do Sul
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Brazil
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São Paulo
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Canada
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Alberta
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Canada
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Ontario
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Estonia
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Tallinn
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Estonia
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Tartu
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France
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Rhône
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France
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Le Kremlin-bicêtre
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France
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Montpellier
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France
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Strasbourg
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Germany
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Datteln
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Germany
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Dresden
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Germany
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Göttingen
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Germany
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Muenster
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Greece
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Attiki
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Greece
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Ahens
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Debrecen
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India
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Delhi
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India
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Gujarat
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India
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Haryana
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India
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Karnataka
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India
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Kerala
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India
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Maharashtra
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Mumbai
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Italy
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Abruzzo
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Italy
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Puglia
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Italy
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Sicilia
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Riga
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Jalisco
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Mexico
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Mexico CITY (federal District)
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Mexico
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Mexico
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Nuevo LEON
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Sinaloa
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Mexico
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Veracruz
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Morocco
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FES
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Morocco
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Marrakech
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Morocco
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Rabat
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Netherlands
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Rotterdam
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Poland
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?ód?
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Gda?sk
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Pozna?
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Poland
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Warszawa
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Lisboa
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Romania
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Bucuresti
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Serbia
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Belgrade
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Serbia
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NIS
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Spain
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Barcelona
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Spain
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Vizcaya
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Switzerland
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Zurich
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Ukraine
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Kharkiv Governorate
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Ukraine
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KIEV Governorate
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Ukraine
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Tavria Okruha
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United Kingdom
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Cambridge
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United Kingdom
State/province [85] 0 0
Edinburgh
Country [86] 0 0
United Kingdom
State/province [86] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
PPD DEVELOPMENT, LP
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: WN42086 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05123703