A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis (Operetta 2)

Roche

Status and phase: Enrolling; Phase 3

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Other: Ocrelizumab Placebo; Drug: Ocrelizumab; Other: Fingolimod Placebo; Drug: Fingolimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT05123703

2020-004128-41 (EudraCT Number)

WN42086

Details and patient eligibility

About

This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks.

Full 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 Multiple Sclerosis aged between 10 and < 18 years. The study plans to enroll 233 patients in a 1:1 randomization (ocrelizumab:fingolimod), globally. This study consists of a double-blind, double dummy period in which patients will be treated with either active ocrelizumab or active fingolimod for at least 96 weeks. Patients who complete the double-blind period will be offered the possibility to enter an optional open-label extension treatment period of at least 144 weeks with ocrelizumab.

Enrollment: 171 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body weight ≥ 40 kg
• Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017
• EDSS at screening: 0-5.5, inclusive
• Neurologic stability for ≥ 30 days prior to screening, and between screening and Day 1
• 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

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 patient from participating in the study
• Patient with severe cardiac disease or significant findings on the screening ECG

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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171 participants in 2 patient groups

Ocrelizumab

Experimental group

Description:

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).

Treatment:

Other: Fingolimod Placebo

Drug: Ocrelizumab

Fingolimod

Active Comparator group

Description:

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).

Treatment:

Drug: Fingolimod

Other: Ocrelizumab Placebo