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 : November 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Relapsing-Remitting Multiple Sclerosis||Drug: Ocrelizumab Other: Ocrelizumab Placebo Drug: Fingolimod Other: Fingolimod Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||233 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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).
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.
Fingolimod will be administered daily as 0.5 mg capsule.
- Annualized relapse rate (ARR) [ Time Frame: Baseline up to approximately 4 years ]
- 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 ]
- Number of new or enlarging T2 lesions by Week 96 [ Time Frame: Baseline up to Week 96 ]
- Annualized relapse rate (ARR) by Week 96 [ Time Frame: Baseline up to Week 96 ]
- Number of T1 Gd lesions at Week 12 [ Time Frame: Week 12 ]
- 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 ]
- Prevalence of ADAs at baseline and incidence of ADAs during the study [ Time Frame: Baseline up to approximately 8 years ]
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
|Contact: Reference Study ID Number: WN42086 https://forpatients.roche.com/||888-662-6728 (U.S. and Canada)||firstname.lastname@example.org|
|Study Director:||Clinical Trials||Hoffmann-La Roche|