What side effects are associated with this type of intervention?

Ocrelizumab, a treatment for MS that targets CD20-positive B cells, is generally well-tolerated but can cause side effects such as infusion-related reactions, infections (including respiratory and herpes infections), and a potential increased risk of malignancies. Other common MS treatments, such as dimethyl fumarate, can cause flushing, gastrointestinal issues, and lymphopenia, while glatiramer acetate may lead to injection site reactions and transient chest pain. Natalizumab, another MS treatment, carries a risk of progressive multifocal leukoencephalopathy (PML), especially in patients with prior immunosuppressant use or positive for anti-JCV antibodies.

What prior FDA approvals exist?

Ocrelizumab, an FDA-approved treatment for Multiple Sclerosis, targets CD20-positive B cells and is used for both relapsing forms of MS and primary progressive MS. Another similar treatment is Rituximab, which also targets CD20-positive B cells, although it is not specifically FDA-approved for MS but is used off-label. Other FDA-approved treatments for MS include Glatiramer acetate, which modulates the immune response, and Dimethyl fumarate, which has anti-inflammatory and neuroprotective effects.

What other types of research exist?

Promising novel alternatives to Ocrelizumab for Multiple Sclerosis patients include: 1) Ofatumumab, another anti-CD20 monoclonal antibody with a similar mechanism but different administration route. 2) Siponimod, a selective sphingosine 1-phosphate receptor modulator that reduces lymphocyte migration into the central nervous system. 3) Cladribine, an oral immunosuppressive drug that targets both B and T lymphocytes. 4) Ozanimod, another sphingosine 1-phosphate receptor modulator with a favorable safety profile. These alternatives offer different mechanisms of action and administration routes, providing more options for personalized treatment plans.

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Monoclonal Antibodies

Subcutaneous Ocrelizumab for Multiple Sclerosis

Phase 1

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018)

For the dose escalation phase for participants pretreated with ocrelizumab (Group A): treatment with IV ocrelizumab for at least 1 year prior to screening (i.e., at least two 600-mg doses of ocrelizumab separated by 24 weeks)

Must not have

History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, human T-lymphotropic virus 1, herpes zoster and myelopathy

Neuromyelitis optica

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called ocrelizumab, which is given as an injection under the skin, on people with multiple sclerosis (MS). The medication helps by lowering the number of specific immune cells that attack the nervous system. Ocrelizumab has been approved for treating both relapsing and primary progressive forms of multiple sclerosis.

Who is the study for?

This trial is for individuals with Primary Progressive or Relapsing Multiple Sclerosis as per McDonald 2017 criteria, with an EDSS score of 0-6.5. Participants must not have had a relapse in the last 30 days and women should agree to use contraception or be post-menopausal/surgically sterile. Those previously treated with IV ocrelizumab for at least a year can join.

What is being tested?

The study tests how the body processes subcutaneous Ocrelizumab injections in people with MS, along with its safety and tolerability. It also looks into the immune response to this medication when administered under the skin rather than intravenously.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with Ocrelizumab may include infusion reactions, infections, lower blood cell counts, and potential liver issues which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with PPMS or RMS according to the McDonald 2017 criteria.

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I have been treated with ocrelizumab for at least a year before screening.

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My disability level allows me to walk at least 100 meters without aid or rest.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a spinal cord condition caused by an infection like syphilis or Lyme disease.

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I have been diagnosed with neuromyelitis optica.

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I have an autoimmune disorder like lupus or Sjögren syndrome.

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I have or had a brain or spinal cord tumor.

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I have had a serious brain or spinal cord injury.

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I have a genetic disorder that affects my brain and nerves.

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I do not have untreated vitamin B12 deficiency causing spinal cord issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group B: Cohorts B1-B4Experimental Treatment2 Interventions

Ocrelizumab treatment- naive participants will receive a minimum of 3 patients in Cohort B will receive a single SC injection of ocrelizumab co-mixed with rHuPH20 in the abdomen. * Cohort B1: 40 mg of SC ocrelizumab * Cohort B2: 200 mg of SC ocrelizumab * Cohort B3: 600 mg of SC ocrelizumab * Cohort B4: 1200 mg of SC ocrelizumab

Group II: Group A: Cohorts A1-A4Experimental Treatment2 Interventions

Participants (participants pretreated with ocrelizumab) will receive a single injection of subcutaneous (SC) ocrelizumab co-mixed with rHuPH20 in the abdomen. For every new dose level, recruitment will be staggered by enrolling 1 participant in each cohort followed by a 48-hour waiting period to review safety and tolerability data by the Safety Monitoring Committee (SMC) prior to enrolling subsequent participants in the same cohort. Currently, the planned dose escalation steps for patients who enroll in Group A are as follows: * Cohort A1: 40 mg of SC ocrelizumab * Cohort A2: 200 mg of SC ocrelizumab * Cohort A3: 600 mg of SC ocrelizumab * Cohort A4: 1200 mg of SC ocrelizumab

Group III: Group A: Cohort AAExperimental Treatment1 Intervention

Participants will receive a single 600-mg dose ocrelizumab by intravenous (IV) infusion

Group IV: Group A: Cohort A5Experimental Treatment2 Interventions

In the non-randomized subphase, participants will receive a single SC injection of ocrelizumab co-mixed with rHuPH20 in the abdomen.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ocrelizumab

2016

Completed Phase 4

~8600

rHuPH20

2019

Completed Phase 2

~780

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ocrelizumab, a monoclonal antibody, targets CD20-positive B cells, which are implicated in the autoimmune response in Multiple Sclerosis (MS). By depleting these B cells, Ocrelizumab reduces inflammation and the immune system's attack on the myelin sheath, which is crucial for nerve function. Other common MS treatments include interferon beta, which modulates the immune response to reduce inflammation, and glatiramer acetate, which mimics myelin protein to divert the immune attack away from actual myelin. These mechanisms are vital for MS patients as they help manage symptoms, reduce relapse rates, and slow disease progression, thereby improving quality of life.