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

Recruiting in Palo Alto (17 mi)

+218 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

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.

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.

+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.

Participant Groups

The 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.

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:

🇪🇺 Approved in European Union as Gilenya for: