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Monoclonal Antibodies

Ocrelizumab for Pediatric Multiple Sclerosis

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female participants of childbearing potential must agree to either remain completely abstinent or to use reliable means of contraception

Children and adolescents must have received all childhood required vaccinations

Must not have

Previous treatment with B-cell-targeted therapies

Lymphocyte count below the lower limit of normal (LLN) for age- and sex-specific reference range

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of a new MS drug in children and adolescents. The goal is to see if it is safe and works well in this age group.

Who is the study for?

This trial is for children and adolescents aged ≥10 to ≤18 with relapsing-remitting multiple sclerosis (RRMS). They must weigh at least 25 kg, be new to disease-modifying therapy, have up-to-date vaccinations, agree to use contraception if applicable, and show neurologic stability for 30 days prior. Participants should not have other neurological disorders that mimic MS or a history of severe infections or cancer.

What is being tested?

The study tests Ocrelizumab's safety and effects in young patients with RRMS over two years. It aims to find the right dosing regimen for further research. The participants will receive Ocrelizumab while being monitored for how their body absorbs and responds to it.

What are the potential side effects?

Ocrelizumab may cause infusion reactions like itching or rash, infections due to weakened immune response, potential liver issues indicated by blood tests, and possibly an increased risk of some types of cancers based on adult studies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use birth control or remain abstinent.

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My child has received all required vaccinations.

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I have been diagnosed with relapsing-remitting multiple sclerosis.

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I have not taken any disease-modifying treatments before.

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My disability level allows me to walk without aid or rest for 200 meters.

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My body weight is at least 25 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with therapies targeting B-cells.

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My lymphocyte count is below the normal range for my age and sex.

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I have a history of or currently have a chronic infection like HIV.

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I have had cancer before, including any type of solid tumor, blood cancer, or early-stage cancer.

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I have not received a live vaccine in the last 6 weeks.

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I do not have aquaporin 4 or MOG antibodies.

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I have an infection that needed hospital care or IV antibiotics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Exploration Period: Area Under the Concentration Versus Time Curve of Ocrelizumab

Dose Exploration Period: Maximum Concentration (Cmax) of Ocrelizumab

Secondary study objectives

Dose Exploration Period: Number of Participants With Antibody Titers Against Standard Vaccines

Dose Exploration Period: Number of Participants With Shift From Baseline in Non-MS Central Nervous System (CNS) Pathology as Measured by Brain Magnetic Resonance Imaging (MRI)

Number of Participants With Adverse Events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4 (optional)Experimental Treatment1 Intervention

Based on PK, PD, safety, and tolerability data analyses of Cohorts 1 and 2, additional participants with a body weight \>/= 40 kg may be enrolled and receive another dose level of ocrelizumab

Group II: Cohort 3 (optional)Experimental Treatment1 Intervention

Based on PK, PD, safety, and tolerability data analyses of Cohorts 1 and 2, additional participants with a body weight from \>/= 25 kg to \< 40 kg may be enrolled and receive another dose level of ocrelizumab

Group III: Cohort 2Experimental Treatment1 Intervention

Participants with a body weight \>/= 40 kg (with at least 2 participants with a body weight \>/= 40 kg but \</= 50 kg) will receive 600 mg ocrelizumab

Group IV: Cohort 1Experimental Treatment1 Intervention

Participants with a body weight from \>/= 25 kg to \< 40 kg (with at least 2 participants with a body weight from \>/= 25 kg to \</= 35 kg) will receive 300 milligram (mg) ocrelizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ocrelizumab

2016

Completed Phase 4

~8600

0 / 13Eligibility criteria met