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Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

23 Participants Needed

Ocrelizumab for Pediatric Multiple Sclerosis

Recruiting at 21 trial locations

Overseen ByReference Study ID Number: WA39085 https://forpatients.roche.com/

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This 2-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, participants must be naive to prior disease-modifying therapy (DMT) or have evidence of disease activity after a full 6-month course of DMT within the past year.

What data supports the effectiveness of the drug Ocrelizumab for treating multiple sclerosis?

Ocrelizumab has been shown to reduce relapse rates and slow disease progression in adults with multiple sclerosis, including both relapsing and primary progressive forms. It is generally well tolerated and provides the convenience of short, half-yearly infusions.¹ ² ³ ⁴ ⁵

How is the drug Ocrelizumab different from other treatments for pediatric multiple sclerosis?

Ocrelizumab is unique because it is the first drug approved for both relapsing and primary progressive forms of multiple sclerosis, and it works by targeting and depleting B cells, which are involved in the disease. It is administered through short, half-yearly infusions, offering convenience compared to other treatments.¹ ² ³ ⁶ ⁷

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

Inclusion Criteria

I agree to use birth control or remain abstinent.

I've had MS treatment for 6 months but my condition worsened after.

My child has received all required vaccinations.

See 5 more

Exclusion Criteria

I do not have other neurological conditions that could be confused with MS.

You have had a severe allergic reaction to a specific type of medication called monoclonal antibodies, or you are allergic to any part of the ocrelizumab solution.

Your CD4 cell count is less than 30%.

See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ocrelizumab based on their body weight in different cohorts

24 weeks

Visits on Days 1, 15, 29, 57, 85, 113, and 169

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 7 years

Open-label extension (optional)

Additional participants may be enrolled based on data analyses of initial cohorts

Treatment Details

Interventions

Ocrelizumab

Trial OverviewThe 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.

Participant Groups

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

Ocrelizumab is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ocrevus for:

Primary progressive multiple sclerosis
Relapsing forms of multiple sclerosis

Approved in European Union as Ocrevus for:

Primary progressive multiple sclerosis
Relapsing forms of multiple sclerosis

Approved in Canada as Ocrevus for:

Primary progressive multiple sclerosis
Relapsing forms of multiple sclerosis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Findings from Research

Ocrelizumab is a humanized anti-CD20 monoclonal antibody specifically designed to deplete B cells, which are implicated in the development of multiple sclerosis (MS).

Approved in March 2017 in the USA for treating both relapsing and primary progressive forms of MS, ocrelizumab represents a significant advancement in MS therapy, with its approval in the EU currently pending.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab: First Global Approval.Frampton, JE.[2022]

Ocrelizumab is the first drug approved by the European Medicines Agency for treating both early primary progressive multiple sclerosis and relapsing forms of multiple sclerosis, highlighting its significance in MS treatment.

The review discusses the safety and effectiveness of ocrelizumab, indicating it has undergone rigorous evaluation to support its use in adults with multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab for multiple sclerosis.[2018]

Ocrelizumab is an effective treatment for both relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), showing significant reductions in relapse rates and disease progression over at least 7.5 years of treatment.

The drug is generally well tolerated, with no new safety concerns identified during long-term use, and offers the convenience of infusions every six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab: A Review in Multiple Sclerosis.Lamb, YN.[2023]