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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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	10 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05123703
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hoffmann-La Roche
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trials
Principal Investigator Affiliation	Hoffmann-La Roche
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Italy, Latvia, Mexico, Morocco, Netherlands, Poland, Portugal, Romania, Serbia, Spain, Switzerland, Ukraine, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsing-Remitting Multiple Sclerosis

Additional Details

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.

Arms & Interventions

Arms

Experimental: Ocrelizumab

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).

Active Comparator: Fingolimod

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).

Interventions

Drug: - Ocrelizumab

Ocrelizumab will be administered at a dose of 600 mg by IV infusion on Day 1 and Day 15 (half the dose, 2 weeks apart) and every 24 weeks thereafter.

Other: - Ocrelizumab Placebo

Ocrelizumab placebo will be administered by IV infusion on day 1 and Day 15 and every 24 weeks thereafter.

Drug: - Fingolimod

Fingolimod will be administered daily as 0.5 mg capsule.

Other: - Fingolimod Placebo

Fingolimod placebo will be administsred daily as a capsule.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UC San Diego; ACTRI, La Jolla, California

Status

Recruiting

Address

UC San Diego; ACTRI

La Jolla, California, 92037

Site Contact

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