NCT05123703

A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This Phase III randomized, double-blind, double-dummy, multicenter study will evaluate the safety and efficacy of ocrelizumab administered by IV infusion every 24 weeks compared with fingolimod taken orally daily, in children and adolescents with RRMS aged between 10 and \< 18 years. The study plans to enroll 171 participants in a 1:1 randomization (ocrelizumab:fingolimod), globally. This study consists of a double-blind, double dummy period in which participants will be treated with either active ocrelizumab or active fingolimod for a flexible duration. Participants who complete the double-blind period will be offered the possibility to enter an optional open-label extension (OLE) treatment period of at least 144 weeks with ocrelizumab.

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Ocrelizumab	Ocrelizumab 300 milligrams (mg) will be administered by IV infusion to participants who weigh \< 35 kilograms (kg) and ocrelizumab 600 mg IV will be administered to participants who weigh ≥ 35 kg on Days 1 and 15 (half the dose, 2 weeks apart) and Q24W thereafter.
OTHER	Ocrelizumab Placebo	Ocrelizumab matching placebo will be administered by IV infusion on Day 1 and Day 15 and Q24W thereafter.
DRUG	Fingolimod	Fingolimod will be administered daily as a capsule per the prescribing information (0.25 mg to participants who weigh ≤ 40 kg and 0.5 mg to participants who weigh \> 40 kg).
OTHER	Fingolimod Placebo	Fingolimod matching placebo will be administered daily as a capsule.

Timeline

• Start date: 2022-05-19
• Primary completion: 2025-06-09
• Completion: 2029-09-17
• First posted: 2021-11-17
• Last updated: 2026-01-30

Locations

102 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Estonia, France, Germany, Greece, Hungary, India, Italy, Latvia, Mexico, Morocco, Poland, Portugal, Romania, Serbia, Spain, Switzerland, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study