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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

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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United States of America
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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 Autonoma Buenos Aires
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Argentina
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Cordoba
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Argentina
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San Miguel
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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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DF
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Brazil
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PR
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Brazil
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RS
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Brazil
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SP
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Bulgaria
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Sofia
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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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Le Kremlin-bicêtre
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France
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Lyon
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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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Athens
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Greece
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Chaidari
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Greece
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Panorama
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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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Abruzzo
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Italy
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Campania
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Italy
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Friuli-Venezia Giulia
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Lazio
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Liguria
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Puglia
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Italy
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Sicilia
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Toscana
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Riga
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Jalisco
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Mexico CITY (federal District)
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Sinaloa
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Monterrey
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Veracruz
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Morocco
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Fez
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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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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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Kragujevac
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Serbia
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NIS
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Serbia
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Nova Sad
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Spain
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Barcelona
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Vizcaya
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Madrid
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Malaga
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Spain
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Sevilla
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Switzerland
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Zürich
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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
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Edinburgh
Country [90] 0 0
United Kingdom
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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
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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