Ocrelizumab vs Fingolimod for Pediatric Multiple Sclerosis
(Operetta 2 Trial)

Recruiting at 219 trial locations

Overseen ByReference Study ID Number: WN42086 https://forpatients.roche.com/

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for children and adolescents aged 10 to under 18 with relapsing-remitting multiple sclerosis (RRMS). They must weigh at least 50 kg, have had recent MS activity, and be neurologically stable. It's not for those with other neurological conditions that look like MS, uncontrolled diseases, active infections, or severe heart issues.

Inclusion Criteria

My disability level allows me to walk without aid or rest for at least 200 meters.

I have been diagnosed with RRMS according to recognized medical standards.

My neurological condition has been stable for over a month.

See 2 more

Exclusion Criteria

I might have or am suspected to have a neurological condition similar to MS.

I do not have any severe illnesses or infections that would stop me from joining the study.

I have severe heart problems or abnormal heart test results.

Treatment Details

Interventions

Fingolimod
Ocrelizumab

Trial OverviewThe study compares the safety and effectiveness of two drugs: Ocrelizumab and Fingolimod. Participants will receive either one of these drugs or a placebo without knowing which one they are getting. The trial will last at least 96 weeks.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: OcrelizumabExperimental Treatment2 Interventions

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.

Group II: FingolimodActive Control2 Interventions

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.

Fingolimod is already approved in European Union, United States, Canada for the following indications: