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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

PHASE3RECRUITING

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.

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Study 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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 10 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-02-04

Primary completion: 2025-07-07

Study completion finish: 2029-09-17

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05123703

Intervention or treatment

DRUG: Ocrelizumab

OTHER: Ocrelizumab Placebo

DRUG: Fingolimod

OTHER: Fingolimod Placebo

Conditions

• Relapsing-Remitting Multiple Sclerosis

Image related to Relapsing-Remitting Multiple Sclerosis

Condition: Relapsing-Remitting Multiple Sclerosis
DRUG: Ocrelizumab and other drugs
Parkville, Victoria, Australia
Sponsor: Hoffmann-La Roche

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Children's Hospital Melbourne - PIN

Research sites nearby

Select from list below to view details:

Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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).	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.
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).	OTHER: Ocrelizumab Placebo Ocrelizumab placebo will be administered by IV infusion on day 1 and Day 15 and every 24 weeks thereafter.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Annualized relapse rate (ARR)	Not Specified	Baseline up to approximately 4 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Number of new or enlarging T2-hyperintense lesions (T2 lesions) as detected by brain MRI during the double-blind period	Not Specified	Baseline up to approximately 4 years
Number of new or enlarging T2 lesions by Week 96	Not Specified	Baseline up to Week 96
Annualized relapse rate (ARR) by Week 96	Not Specified	Baseline up to Week 96
Number of T1 Gd lesions at Week 12	Not Specified	Week 12
Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)	Not Specified	Baseline up to approximately 8 years
Prevalence of ADAs at baseline and incidence of ADAs during the study	Not Specified	Baseline up to approximately 8 years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis