Ocrelizumab for Multiple Sclerosis

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Johns Hopkins University

Must be taking: Injectable DMTs

Must not be taking: Steroids, B-cell depleting antibodies

Disqualifiers: Hepatitis B, Pregnancy, 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: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called ocrelizumab (also known as Ocrevus or Ocrevus Zunovo) to evaluate its effectiveness in helping people with relapsing-remitting multiple sclerosis (RRMS). The researchers aim to determine if ocrelizumab can effectively halt the disease by targeting specific immune cells called B-cells. Participants will receive the medication and be monitored to assess whether their MS symptoms improve or remain controlled over time. Individuals diagnosed with RRMS who have experienced recent changes in their brain or spinal cord on an MRI might be suitable for this study. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

If you are currently on certain disease-modifying therapies (DMTs) like natalizumab, fingolimod, or DMF, you need to stop them for at least three months before joining the trial. If you are on injectable DMTs like interferons or glatiramer acetate, you may continue them.

What is the safety track record for this treatment?

Research shows that ocrelizumab is generally well-tolerated by people with multiple sclerosis (MS). In previous studies, most participants did not experience serious side effects. About 70% of those who took ocrelizumab reported infections, compared to 68% of those who took a placebo, suggesting a similar risk of infection with or without the drug.

Ocrelizumab has already received approval for treating MS, providing some reassurance about its safety. The main concerns involve reactions during or after intravenous administration, which are usually mild and manageable by healthcare providers.

Overall, evidence indicates that ocrelizumab is generally safe for most people, with careful monitoring to manage any potential reactions. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Ocrelizumab is unique because it targets a specific protein called CD20 on the surface of B cells, which are a type of immune cell involved in the abnormal immune response seen in multiple sclerosis (MS). Unlike traditional MS treatments, which often focus on managing symptoms or reducing inflammation generally, ocrelizumab works by depleting these B cells, potentially leading to a more direct and effective suppression of disease activity. Researchers are excited about its ability to halt disease progression and its potential to offer longer-term control of MS symptoms with less frequent dosing compared to other therapies.

What is the effectiveness track record for ocrelizumab in treating multiple sclerosis?

Studies have shown that ocrelizumab effectively treats relapsing multiple sclerosis (MS). It can reduce the risk of worsening disability by about 30% over 12 weeks in people with advanced MS. Research also indicates that it slows the progression of disability over two years compared to Rebif. Ocrelizumab targets B-cells, which play a crucial role in MS, helping to halt disease progression while maintaining normal B-cell and T-cell function. Overall, ocrelizumab is considered effective for managing relapsing MS. ^{2 5 6 7 8}

Who Is on the Research Team?

Bardia Nourbakhsh

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for people with relapsing-remitting multiple sclerosis (RRMS) who have an EDSS score of 3 or less, are not pregnant, and agree to use effective contraception. They must have recent MRI changes indicative of MS activity but can't join if they're allergic to ocrelizumab, previously used certain MS drugs or treatments, are pregnant/lactating, or have active hepatitis B.

Inclusion Criteria

I have been diagnosed with relapsing-remitting MS.

Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use one method of contraception with a failure rate of <1% per year or a barrier method supplemented with spermicide. Contraception must continue for the duration of study treatment and for at least 24 weeks after the last dose of study treatment

My disability level is low, with a score of 3 or less.

Exclusion Criteria

I have received treatments that target B-cells or had a stem-cell transplant.

I cannot receive CD20 antibody treatment due to health reasons.

I have not taken steroids in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive two courses of ocrelizumab over one year

12 months

Multiple visits (in-person)

Follow-up

Participants are monitored clinically and radiologically for return of disease activity

18-24 months

Regular visits (in-person)

Open-label extension (optional)

Participants with return of disease activity can resume ocrelizumab treatment

Up to 30 months

What Are the Treatments Tested in This Trial?

Interventions

• Ocrelizumab

Trial Overview The study tests Ocrelizumab's effect on B-cell tolerance defects in RRMS patients. It involves treating participants with two courses of the drug and monitoring them clinically and through MRIs for over two years to see how their immune cells behave post-treatment.

How Is the Trial Designed?

Group I: Ocrelizumab Experimental Treatment 1 Intervention

Patients will be treated with two courses of ocrelizumab (Ocrevus) for one year and then will stop the medication and will be monitored for the return of the disease activity. Those who experience the return of the disease activity can go back on the medication.

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?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

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

Efficacy | OCREVUS® (ocrelizumab) Long-term reduction in 48-week confirmed disability progression after 5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis. Presented ...

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

Genentech: Press Releases | Tuesday, Sep 23, 2025 Ocrevus shows 30% reduction in the risk of time to onset of 12-week composite confirmed disability progression (cCDP) in adults with advanced ...

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

Roche presents new data for OCREVUS and fenebrutinib ... OCREVUS shows 30% reduction in the risk of time to onset of 12-week composite confirmed disability progression (cCDP) in adults with advanced ...

4. 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 ...

5. ocrevus-hcp.com ocrevus-hcp.com/content/dam/gene/ocrevus-hcp/pdfs/ocrevus-zunovo-core-data-brochure.pdf

OCREVUS ZUNOVO Core Data Brochure OCREVUS and OCREVUS ZUNOVO are indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing- ...

6. ocrevus-hcp.com ocrevus-hcp.com/ocrevus-zunovo/safety.html

Safety | OCREVUS ZUNOVO® (ocrelizumab & hyaluronidase ... In the PPMS trial, 70% of OCREVUS-treated patients experienced one or more infections compared to 68% of patients on placebo. OCREVUS was not associated with an ...

7. roche.com roche.com/media/releases/med-cor-2024-09-16

FDA approves OCREVUS ZUNOVO™ as the first and only ... Additionally, one of several patient-reported outcomes measured during the study showed more than 92% of trial participants reported being ...

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

Ocrevus Zunovo - accessdata.fda.gov The safety of ocrelizumab has been evaluated in active-controlled clinical trials of ocrelizumab administered intravenously in patients with relapsing forms of ...