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

Trial Summary

What is the purpose of this trial?

B cell-depleting therapies, such as ocrelizumab, are among the most effective medications currently available for the treatment of multiple sclerosis (MS). This suggests that B cells play a very important role in MS. While B cells are rapidly eliminated from the blood of patients treated with medications like ocrelizumab, little is known about how effectively B cells are eliminated from lymph nodes, which are important sites of B cell activation. This study is being conducted to determine to what extent B cells are targeted in lymph nodes following ocrelizumab treatment, which may have important consequences for long-term MS outcomes.

Research Team

Joseph Sabatino, MD, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

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

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

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

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

Treatment Details

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.

Participant Groups

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