Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05123703




Registration number
NCT05123703
Ethics application status
Date submitted
16/11/2021
Date registered
17/11/2021
Date last updated
6/06/2024

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
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 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).

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).


Treatment: Drugs: 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 interventions: Ocrelizumab Placebo
Ocrelizumab placebo will be administered by IV infusion on day 1 and Day 15 and every 24 weeks thereafter.

Treatment: Drugs: Fingolimod
Fingolimod will be administered daily as 0.5 mg capsule.

Other interventions: Fingolimod Placebo
Fingolimod placebo will be administsred 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 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
Annualized relapse rate (ARR) by Week 96
Timepoint [3] 0 0
Baseline up to Week 96
Secondary outcome [4] 0 0
Number of T1 Gd lesions at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
Baseline up to approximately 8 years
Secondary outcome [6] 0 0
Prevalence of 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 = 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
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 patient from participating in the study

- Patient with severe cardiac disease or significant findings on the screening ECG

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
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
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Argentina
State/province [14] 0 0
Ciudad Autonoma Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Cordoba
Country [16] 0 0
Argentina
State/province [16] 0 0
San Miguel
Country [17] 0 0
Austria
State/province [17] 0 0
Wien
Country [18] 0 0
Belgium
State/province [18] 0 0
Brussel
Country [19] 0 0
Belgium
State/province [19] 0 0
Bruxelles
Country [20] 0 0
Belgium
State/province [20] 0 0
Gent
Country [21] 0 0
Brazil
State/province [21] 0 0
DF
Country [22] 0 0
Brazil
State/province [22] 0 0
PR
Country [23] 0 0
Brazil
State/province [23] 0 0
RS
Country [24] 0 0
Brazil
State/province [24] 0 0
SP
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Sofia
Country [26] 0 0
Canada
State/province [26] 0 0
Alberta
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Croatia
State/province [28] 0 0
Split
Country [29] 0 0
Croatia
State/province [29] 0 0
Zagreb
Country [30] 0 0
Denmark
State/province [30] 0 0
Aarhus N
Country [31] 0 0
Denmark
State/province [31] 0 0
Glostrup
Country [32] 0 0
Estonia
State/province [32] 0 0
Tallinn
Country [33] 0 0
Estonia
State/province [33] 0 0
Tartu
Country [34] 0 0
France
State/province [34] 0 0
Le Kremlin-bicêtre
Country [35] 0 0
France
State/province [35] 0 0
Lyon
Country [36] 0 0
France
State/province [36] 0 0
Montpellier
Country [37] 0 0
France
State/province [37] 0 0
Strasbourg
Country [38] 0 0
Germany
State/province [38] 0 0
Datteln
Country [39] 0 0
Germany
State/province [39] 0 0
Dresden
Country [40] 0 0
Germany
State/province [40] 0 0
Göttingen
Country [41] 0 0
Germany
State/province [41] 0 0
Muenster
Country [42] 0 0
Greece
State/province [42] 0 0
Athens
Country [43] 0 0
Greece
State/province [43] 0 0
Chaidari
Country [44] 0 0
Greece
State/province [44] 0 0
Panorama
Country [45] 0 0
Greece
State/province [45] 0 0
Thessaloniki
Country [46] 0 0
Hungary
State/province [46] 0 0
Budapest
Country [47] 0 0
Hungary
State/province [47] 0 0
Debrecen
Country [48] 0 0
India
State/province [48] 0 0
Delhi
Country [49] 0 0
India
State/province [49] 0 0
Gujarat
Country [50] 0 0
India
State/province [50] 0 0
Haryana
Country [51] 0 0
India
State/province [51] 0 0
Karnataka
Country [52] 0 0
India
State/province [52] 0 0
Kerala
Country [53] 0 0
India
State/province [53] 0 0
Maharashtra
Country [54] 0 0
Italy
State/province [54] 0 0
Abruzzo
Country [55] 0 0
Italy
State/province [55] 0 0
Campania
Country [56] 0 0
Italy
State/province [56] 0 0
Friuli-Venezia Giulia
Country [57] 0 0
Italy
State/province [57] 0 0
Lazio
Country [58] 0 0
Italy
State/province [58] 0 0
Liguria
Country [59] 0 0
Italy
State/province [59] 0 0
Lombardia
Country [60] 0 0
Italy
State/province [60] 0 0
Sicilia
Country [61] 0 0
Italy
State/province [61] 0 0
Toscana
Country [62] 0 0
Latvia
State/province [62] 0 0
Riga
Country [63] 0 0
Mexico
State/province [63] 0 0
Jalisco
Country [64] 0 0
Mexico
State/province [64] 0 0
Mexico CITY (federal District)
Country [65] 0 0
Mexico
State/province [65] 0 0
Michoacan
Country [66] 0 0
Mexico
State/province [66] 0 0
Sinaloa
Country [67] 0 0
Mexico
State/province [67] 0 0
Durango
Country [68] 0 0
Mexico
State/province [68] 0 0
Monterrey
Country [69] 0 0
Mexico
State/province [69] 0 0
Veracruz
Country [70] 0 0
Morocco
State/province [70] 0 0
Fez
Country [71] 0 0
Morocco
State/province [71] 0 0
Marrakech
Country [72] 0 0
Morocco
State/province [72] 0 0
Rabat
Country [73] 0 0
Netherlands
State/province [73] 0 0
Rotterdam
Country [74] 0 0
Poland
State/province [74] 0 0
?ód?
Country [75] 0 0
Poland
State/province [75] 0 0
Gda?sk
Country [76] 0 0
Poland
State/province [76] 0 0
Pozna?
Country [77] 0 0
Poland
State/province [77] 0 0
Warszawa
Country [78] 0 0
Portugal
State/province [78] 0 0
Braga
Country [79] 0 0
Portugal
State/province [79] 0 0
Coimbra
Country [80] 0 0
Portugal
State/province [80] 0 0
Lisboa
Country [81] 0 0
Romania
State/province [81] 0 0
Bucuresti
Country [82] 0 0
Serbia
State/province [82] 0 0
Belgrade
Country [83] 0 0
Serbia
State/province [83] 0 0
Kragujevac
Country [84] 0 0
Serbia
State/province [84] 0 0
NIS
Country [85] 0 0
Serbia
State/province [85] 0 0
Nova Sad
Country [86] 0 0
Spain
State/province [86] 0 0
Barcelona
Country [87] 0 0
Spain
State/province [87] 0 0
Vizcaya
Country [88] 0 0
Spain
State/province [88] 0 0
Madrid
Country [89] 0 0
Spain
State/province [89] 0 0
Malaga
Country [90] 0 0
Spain
State/province [90] 0 0
Sevilla
Country [91] 0 0
Switzerland
State/province [91] 0 0
Genève
Country [92] 0 0
Switzerland
State/province [92] 0 0
Zürich
Country [93] 0 0
Ukraine
State/province [93] 0 0
Kharkiv Governorate
Country [94] 0 0
Ukraine
State/province [94] 0 0
Tavria Okruha
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Birmingham
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Cambridge
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Edinburgh
Country [98] 0 0
United Kingdom
State/province [98] 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
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05123703
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05123703