Ocrelizumab for Pediatric Multiple Sclerosis

Not currently recruiting at 28 trial locations

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

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must not be taking: B-cell therapies

Disqualifiers: Other neurologic disorders, Chronic infection, Cancer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a medication called ocrelizumab for children and teens with relapsing-remitting multiple sclerosis (RRMS). The study aims to assess the safety and tolerability of ocrelizumab and its behavior in the body to determine the best dose for future studies. Participants must have RRMS and have been on disease-modifying therapy (DMT) for at least six months within the last year, yet still experienced symptoms like relapses. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in RRMS treatment.

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.

Is there any evidence suggesting that ocrelizumab is likely to be safe for children and adolescents with relapsing-remitting multiple sclerosis?

Research has shown that ocrelizumab is generally well-tolerated in adults with multiple sclerosis (MS). Studies have found that the most common side effect is a reaction at the injection site, with about 49% of patients experiencing this. These reactions can vary but often include symptoms like redness or swelling at the injection site.

Ocrelizumab also carries a higher risk of infections, including those affecting the lungs and skin. However, the safety of ocrelizumab in children remains unestablished.

This trial aims to assess the safety and tolerability of ocrelizumab in children and teens with relapsing-remitting multiple sclerosis (RRMS). As the study is in an early phase, researchers are still gathering information to ensure the treatment is safe for younger patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple sclerosis?

Unlike the standard treatments for pediatric multiple sclerosis, which often include beta interferons or glatiramer acetate, ocrelizumab targets a specific protein called CD20 on B cells. This approach is unique because it selectively depletes B cells, which play a critical role in the autoimmune process that damages the nervous system in multiple sclerosis. Researchers are excited about ocrelizumab because it offers a tailored mechanism of action that could potentially be more effective in reducing disease activity and progression in young patients. This specificity might also mean fewer side effects compared to broader immunosuppressive therapies.

What evidence suggests that ocrelizumab might be an effective treatment for pediatric multiple sclerosis?

Research has shown that ocrelizumab effectively treats multiple sclerosis (MS). Studies have found it significantly slows the worsening of disability in people with relapsing forms of MS. In short-term studies with children, ocrelizumab was well-tolerated and helped reduce relapses while maintaining stable disability. Over two years, it proved more effective at slowing disability progression compared to Rebif. With over ten years of trial data, ocrelizumab consistently demonstrates benefits for those with relapsing MS. Participants in this trial will receive different dose levels of ocrelizumab based on their body weight, as part of the various treatment cohorts. ^{5 6 7 8 9}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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.

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%.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Ocrelizumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort 4 (optional) Experimental Treatment 1 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 Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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

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

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Published Research Related to This Trial

In a study of 130 individuals with relapsing and progressive multiple sclerosis, treatment with ocrelizumab led to significant improvements in health-related quality of life (HRQOL) after 12 months, particularly in mental health domains.

The improvements were measured using patient-reported outcome tools, showing enhanced scores in areas like vitality, emotional health, and reduced anxiety, indicating that ocrelizumab not only affects physical symptoms but also positively impacts mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of ocrelizumab on health-related quality of life in individuals with multiple sclerosis. Glanz, BI., Zurawski, J., Casady, EC., et al.[2022]

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]

Ocrelizumab is the first approved treatment for both relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS), demonstrating significant efficacy in slowing disability progression in PPMS patients at 12 and 24 weeks.

The safety profile of ocrelizumab aligns with findings from clinical trials, showing no unexpected safety concerns, which supports its use in managing multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab: its efficacy and safety in multiple sclerosis. Juanatey, A., Blanco-Garcia, L., Tellez, N.[2019]

Citations

1. ocrevus.com ocrevus.com/patient/ocrevus-101/relapsing-multiple-sclerosis.html

OCREVUS® (ocrelizumab) Results for RMS (Relapsing MS) OCREVUS was proven effective at slowing disability progression compared with Rebif across 2 years. Disability progression was confirmed 3 months after the ...

2. ocrevus-hcp.com ocrevus-hcp.com/ocrevus/efficacy.html

Efficacy | OCREVUS® (ocrelizumab) Explore 10+ years of clinical trial efficacy data for OCREVUS® (ocrelizumab). See full safety for more information.

3. gene.com gene.com/media/press-releases/15078/2025-09-23/genentech-presents-new-data-for-ocrevus-

Genentech: Press Releases | Tuesday, Sep 23, 2025 New data show that treatment with Ocrevus provides significant benefit in preventing disability progression across diverse groups of people ...

4. roche.com roche.com/media/releases/med-cor-2025-09-24

Roche presents new data for OCREVUS and fenebrutinib ... OCREVUS subcutaneous maintains consistent benefit-risk profile after two years; New late-breaking data confirms OCREVUS significantly ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40848619/

Efficacy and safety of ocrelizumab in pediatric multiple ... In this cohort, ocrelizumab was well-tolerated with reduced relapse rates and stable disability scores over the short-term follow-up.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/761371s000lbl.pdf

Ocrevus Zunovo - accessdata.fda.gov OCREVUS ZUNOVO can cause injection reactions, which can be local or systemic. Common symptoms of local injection reactions reported by patients treated with ...

7. ocrevus-hcp.com ocrevus-hcp.com/ocrevus/safety.html

Safety | OCREVUS® (ocrelizumab) The most common adverse reaction observed with OCREVUS ZUNOVO in patients with RMS and PPMS was injection reactions (incidence of 49%).

8. gene.com gene.com/patients/medicines/ocrevus-zunovo

Ocrevus Zunovo™ (ocrelizumab and hyaluronidase-ocsq) Primary progressive MS, in adults. It is not known if OCREVUS ZUNOVO is safe and effective in children. Who should not receive OCREVUS ZUNOVO? Do not receive ...

9. ocrevus.com ocrevus.com/

OCREVUS® (ocrelizumab) | Multiple Sclerosis (MS) Treatment OCREVUS and OCREVUS ZUNOVO increase your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes ...