Operetta 2
What it found
No result yet.
What was tested
Treatment tested
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
Compared with
Placebo or sham
- Ocrelizumab Placebo
- Fingolimod Placebo
- Placebo for FINGOLIMOD
- Placebo for Ocrelizumab
Results by group
Protocol-defined Annualized Relapse Rate (ARR)
Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ocrelizumab | 0.070 relapses per patient-year | 0.034–0.144 | 93 |
| Fingolimod | 0.135 relapses per patient-year | 0.075–0.243 | 94 |
Ocrelizumab
Fingolimod
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Ocrelizumab | 93 | 6 (6.5%) | 0 |
| Fingolimod | 92 | 8 (8.7%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Protocol-defined Annualized Relapse Rate (ARR)
Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)
Disability progressionRelapses
Other measures (16)
Protocol-defined ARR
Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)
Disability progressionRelapsesNumber of New or Enlarging T2-hyperintense Lesions (T2 Lesions), as Detected by Brain Magnetic Resonance Imaging (MRI)
Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)
MRI lesionsNumber of T1 Gd Lesions at Week 12
At Week 12
MRI lesionsNumber of Participants With Adverse Events (AEs)
Up to approximately 7 years
SafetyMaximum Serum Concentration (Cmax) of Ocrelizumab
Cycle (1 Cycle=24 weeks)
How the body handles the medicineArea Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC Tau) of Ocrelizumab
Cycle 1 (1 Cycle=24 weeks)
How the body handles the medicineNumber of Participants With Anti-drug Antibodies (ADAs) to Ocrelizumab
Up to approximately 7 years
Immune responseLevels of Cluster of Differentiation 19 (CD19) + B-cell Count in Blood
Up to approximately 7 years
Immune response3. Protocol-defined ARR during the double-blind period (superiority)
Relapses4. 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)
Safety
Who could take part
Relapsing MS · 10 to 17
Inclusion Criteria: * Body weight ≥ 25 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 prior to randomization Inclusion Criteria for Optional OLE Period: -Participants in Group A (ocrelizumab in the 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 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and \< 18 years over a flexible duration. The double-blind period will last until after the last participant randomized has completed 24 weeks.
Papers
Loading reviews and guidelines…
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History
Started
May 2022
Main results due
Jun 2025
Finished
Sept 2029
Results posted
Jul 2026
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