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Instituto de Investigaciones Aplicadas a la Neurociencia A.C. | Durango, Mexico

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A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS) (Operetta 2)

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Roche

Status and phase

Active, not recruiting
Phase 3

Conditions

Relapsing-Remitting Multiple Sclerosis

Treatments

Drug: Ocrelizumab
Drug: Fingolimod
Other: Ocrelizumab Placebo
Other: Fingolimod Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05123703
2020-004128-41 (EudraCT Number)
WN42086
2023-506516-40-00 (Registry Identifier)

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 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.

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 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.

Enrollment

171 estimated patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Body weight ≥ 25 kilograms (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

Inclusion Criteria for Optional OLE Period:

-Participants in Group A (ocrelizumab in the double-blind period [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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

171 participants in 2 patient groups

Ocrelizumab
Experimental group
Description:
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.
Treatment:
Other: Fingolimod Placebo
Drug: Ocrelizumab
Fingolimod
Active Comparator group
Description:
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.
Treatment:
Other: Ocrelizumab Placebo
Drug: Fingolimod

Trial contacts and locations

112

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Central trial contact

Reference Study ID Number: WN42086 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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