← Back to Search

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 6 months, up to 5 years
Awards & highlights

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
Select...
I agree to use birth control or remain abstinent.
Select...
My child has received all required vaccinations.
Select...
I have been diagnosed with relapsing-remitting multiple sclerosis.
Select...
I have not taken any disease-modifying treatments before.
Select...
My disability level allows me to walk without aid or rest for 200 meters.
Select...
My body weight is at least 25 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been treated with therapies targeting B-cells.
Select...
My lymphocyte count is below the normal range for my age and sex.
Select...
I have a history of or currently have a chronic infection like HIV.
Select...
I have had cancer before, including any type of solid tumor, blood cancer, or early-stage cancer.
Select...
I have not received a live vaccine in the last 6 weeks.
Select...
I do not have aquaporin 4 or MOG antibodies.
Select...
I have an infection that needed hospital care or IV antibiotics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Antibody Titers Against Standard Vaccines
Developmental Milestones: Age at menarche, related with the female reproductive status
Developmental Milestones: Bone age assessment by wrist/hand radiographs
+3 more

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
~7260

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,444 Previous Clinical Trials
1,093,086 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,997 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,212 Previous Clinical Trials
892,380 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
18,323 Patients Enrolled for Multiple Sclerosis

Media Library

Ocrelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04075266 — Phase 2
Multiple Sclerosis Research Study Groups: Cohort 1, Cohort 4 (optional), Cohort 2, Cohort 3 (optional)
Multiple Sclerosis Clinical Trial 2023: Ocrelizumab Highlights & Side Effects. Trial Name: NCT04075266 — Phase 2
Ocrelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04075266 — Phase 2
~6 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top