Ocrelizumab for Multiple Sclerosis

(OCREFINA Trial)

Overseen By Joseph Sabatino, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Must be taking: Ocrelizumab

Must not be taking: Systemic corticosteroids, Immunosuppressants

Disqualifiers: Cancer, Chronic infection, Immunodeficiency, 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: 3

Duration: 6 months

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well the medication ocrelizumab (also known as Ocrevus or Ocrevus Zunovo) targets B cells in the lymph nodes of people with relapsing-remitting multiple sclerosis (RR-MS). B cells, a type of white blood cell, may play a significant role in MS, and understanding their behavior could improve long-term outcomes. Participants will receive ocrelizumab infusions, which serve as a standard treatment for MS. The trial seeks individuals diagnosed with RR-MS who have not yet started treatment and whose symptoms began less than 15 years ago. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial requires participants to be treatment-naïve, meaning they should not have taken any disease-modifying therapy for multiple sclerosis before. If you are currently on such medications, you would need to stop them to participate.

What is the safety track record for ocrelizumab?

Research has shown that ocrelizumab is generally well-tolerated by patients. In studies for relapsing multiple sclerosis (RMS), 58% of patients taking ocrelizumab reported infections, compared to 52% of those taking another drug, Rebif. This indicates that slightly more than half of the patients experienced infections, a common occurrence with both treatments.

Ocrelizumab has been used to treat multiple sclerosis for some time, supporting its safety profile. Some patients have experienced reactions during IV administration, which is important to note. Overall, evidence suggests that ocrelizumab is relatively safe for use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Ocrelizumab is unique because it targets CD20-positive B cells, which play a crucial role in the progression of multiple sclerosis (MS). Unlike standard treatments like interferons or glatiramer acetate that modulate the immune system more generally, ocrelizumab directly depletes these specific B cells, potentially reducing the frequency and severity of relapses in RR-MS. Researchers are excited about this treatment because its targeted approach may offer improved outcomes and a more favorable safety profile compared to broader immune-modulating therapies.

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

Research has shown that ocrelizumab, which participants in this trial will receive, effectively treats multiple sclerosis (MS). Studies have found that it can reduce the risk of worsening disability by 30% in people with advanced MS. It remains the only approved treatment for primary progressive multiple sclerosis (PPMS) and can help delay symptom progression. Fewer patients experience symptom worsening with ocrelizumab compared to those receiving a placebo. Overall, ocrelizumab ranks among the most effective medications for MS because it targets B cells, which play a crucial role in the disease. ^{4 6 7 8 9}

Who Is on the Research Team?

Joseph Sabatino, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals with Multiple Sclerosis (MS). Specific eligibility criteria are not provided, but typically participants must have a confirmed diagnosis of MS and meet certain health requirements.

Inclusion Criteria

My neurologist has decided ocrelizumab is the best treatment for me.

Ability to provide written informed consent and be compliant with the study protocol

I agree to use birth control or abstain from sex for 6 months after my last ocrelizumab dose.

Exclusion Criteria

Positive serum or urine β-hCG

AST or ALT more than 2 times the upper limit of normal

Platelet count below lower limit of normal

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two doses of 300 mg i.v. ocrelizumab two weeks apart followed by 600 mg i.v. ocrelizumab six months later

6 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Ocrelizumab

Trial Overview The study tests the effects of Ocrelizumab, a medication that targets B cells, on immune cells within lymph nodes in people with MS. It aims to understand how well B cells are eliminated from these areas after treatment.

How Is the Trial Designed?

Group I: RR-MS Experimental Treatment 1 Intervention

Two doses of 300 mg i.v. ocrelizumab two weeks apart followed by 600 mg i.v. ocrelizumab six months later.

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?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

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) In RMS trials, 58% of OCREVUS-treated patients experienced one or more infections compared to 52% of REBIF-treated patients. In the PPMS trial, 70% of OCREVUS- ...

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. ocrevus.com ocrevus.com/patient/ocrevus-101/primary-progressive-multiple-sclerosis.html

results in primary progressive ms (ppms) Proven effective · OCREVUS is the only approved treatment for PPMS · Clinical study by the numbers · OCREVUS was proven to delay disability progression of PPMS.

4. 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 ...

5. rarediseaseadvisor.com rarediseaseadvisor.com/therapies/ocrevus-ocrelizumab/

Ocrevus and Ocrevus Zunovo Results have shown that fewer patients treated with Ocrevus had worsening symptoms compared to those treated with placebo.4 Data also showed ...

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

OCREVUS ZUNOVO Core Data Brochure Select Important Safety Information. The warnings and precautions for ocrelizumab are infusion reactions (OCREVUS) or injection reactions (OCREVUS ZUNOVO).

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

OCREVUS® (ocrelizumab) Results for RMS (Relapsing MS) In 2 large, identical clinical studies over 2 years, OCREVUS was proven effective against Rebif, a currently approved treatment for relapsing MS, not a placebo.

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

Safety | OCREVUS® (ocrelizumab) In RMS trials, 58% of OCREVUS-treated patients experienced one or more infections compared to 52% of REBIF-treated patients. In the PPMS trial, 70% of OCREVUS- ...

9. 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 ...