Ocrelizumab for Progressive Multiple Sclerosis

(CONSONANCE Trial)

Not currently recruiting at 247 trial locations

Overseen By Reference Study ID Number: MN39159 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must not be taking: B-cell therapies, Alemtuzumab, Corticosteroids, others

Disqualifiers: RRMS, Pregnancy, Immunodeficiency, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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: Unknown

Duration: 192 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of ocrelizumab, administered through IV infusion, in individuals with progressive multiple sclerosis (PMS). The researchers aim to determine how well this drug slows disease progression without being linked to relapse events. Individuals with a confirmed PMS diagnosis who have experienced worsening symptoms over the past two years, independent of relapses, might be suitable candidates. Participants should be comfortable using smartphones and connecting to Wi-Fi. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before participating. For example, if you've taken teriflunomide, you need a washout period (time without the medication) or an accelerated elimination procedure. Other medications like siponimod, natalizumab, and systemic corticosteroids also have specific timeframes for discontinuation before the trial.

Is there any evidence suggesting that Ocrelizumab is likely to be safe for humans?

Research has shown that Ocrelizumab, the treatment under study, is already approved for primary progressive multiple sclerosis (PPMS), providing insight into its safety. In a previous study, 70% of patients who took Ocrelizumab experienced infections, similar to the 68% of patients who had infections with a placebo, a harmless pill used for comparison. Warnings have also been issued about infusion reactions, which can occur when the drug is administered through an IV.

Overall, Ocrelizumab appears to be as well-tolerated as other treatments for multiple sclerosis. However, like any medication, it can have side effects, so patients should discuss these with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Ocrelizumab is unique because it specifically targets CD20-positive B cells, which are believed to play a key role in the progression of multiple sclerosis (MS). Unlike traditional MS treatments that focus primarily on T cells or general immune suppression, Ocrelizumab offers a more targeted approach, potentially leading to better outcomes for patients with progressive forms of the disease. Researchers are excited about this treatment because its mechanism of action could slow down or even halt the progression of MS, offering hope for improved quality of life for those affected.

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

Research shows that Ocrelizumab, which participants in this trial will receive, effectively treats progressive multiple sclerosis (PMS). Studies have found that it can significantly slow the progression of disability in patients. Ocrelizumab is already approved for primary progressive multiple sclerosis (PPMS) and remains the only treatment currently approved for this condition. Data from over ten years of clinical trials supports its safety and effectiveness, making Ocrelizumab a strong option for helping people with progressive forms of multiple sclerosis manage their symptoms. ^{1 4 5 6 7}

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 adults with Progressive Multiple Sclerosis (PMS) who've had disability progression in the last 2 years, can use a smartphone with Wi-Fi, and have an EDSS score of 6.5 or less. Women must agree to contraception during treatment and afterward. Exclusions include recent other MS treatments, severe immune conditions, certain drug intolerances, active infections, pregnancy, or previous ocrelizumab use.

Inclusion Criteria

Have a documented evidence of disability progression independent of relapse at any point over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician's judgment

Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers

Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist

Exclusion Criteria

I haven't taken any corticosteroids in the last 4 weeks.

History or currently active primary or secondary immunodeficiency

I've had treatments targeting B-cells, but not rituximab in the last 6 months, and my B-cell levels are normal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Ocrelizumab is administered via intravenous infusion to participants with progressive multiple sclerosis

192 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ocrelizumab

Trial Overview The study tests Ocrelizumab's effectiveness and safety in treating PMS. It's an open-label trial where all participants receive the drug; there are no comparison groups. The focus is on how well it works over time and what side effects occur.

How Is the Trial Designed?

Group I: Ocrelizumab Experimental Treatment 1 Intervention

Ocrelizumab will be administered via intravenous (IV) infusion.

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

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 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]

In a review of 78 studies involving 4498 patients, 61.3% of those treated with ocrelizumab experienced adverse events, with the most common being infections (39.2%) and infusion-related reactions (26.2%).

Ocrelizumab was associated with a higher risk of infections compared to beta-interferon, particularly herpes-related and respiratory infections, while the risk of serious adverse events was similar between ocrelizumab and comparator groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of ocrelizumab for the treatment of multiple sclerosis: a systematic review. Ng, HS., Rosenbult, CL., Tremlett, H.[2022]

Ocrelizumab significantly reduces annualized relapse rates in adults with relapsing multiple sclerosis (RMS) compared to interferon β-1a, based on results from two 96-week trials.

In patients with primary progressive multiple sclerosis (PPMS), ocrelizumab significantly lowers the risk of confirmed disability progression over 120 weeks compared to placebo, and it is generally well tolerated with mostly mild to moderate side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab: A Review in Multiple Sclerosis. Syed, YY.[2022]

Ocrelizumab, an anti-CD20 monoclonal antibody, is effective in reducing disability progression in primary progressive multiple sclerosis, but it can lead to severe late-onset neutropenia as a rare side effect.

In a reported case, a 34-year-old male developed severe neutropenia 42 days after receiving ocrelizumab, requiring hospitalization and treatment, highlighting the need for patient awareness and monitoring for symptoms like fever.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe Delayed-Onset Neutropenia Induced by Ocrelizumab. Baird-Gunning, J., Yun, J., Stevenson, W., et al.[2022]

In a post hoc analysis of pivotal trials, ocrelizumab significantly reduced the risk of confirmed disability progression in multiple sclerosis patients with higher baseline disability (Expanded Disability Status Scale scores ≥4.0).

The analysis included patients from the OPERA trials (relapsing MS) and ORATORIO trial (primary progressive MS), showing that ocrelizumab was more effective than interferon β-1a and placebo in slowing disability progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploratory analysis of the efficacy of ocrelizumab in patients with multiple sclerosis with increased disability. Wolinsky, JS., Engmann, NJ., Pei, J., et al.[2022]

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-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.

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

results in primary progressive ms (ppms) OCREVUS is the only approved treatment for PPMS. Find out why OCREVUS may be the right choice for treating your primary progressive multiple sclerosis (PPMS).

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 with ...

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

FDA approves OCREVUS ZUNOVO™ as the first and only ... “OCREVUS ZUNOVO gives patients and providers another option for receiving OCREVUS, building on a decade of robust safety and efficacy data for ...

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

OCREVUS ZUNOVO Core Data Brochure Ocrelizumab infusion experience in patients with relapsing and primary progressive multiple sclerosis: results from the phase 3 randomized. OPERA I, OPERA II ...

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

Safety | OCREVUS® (ocrelizumab) 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/investors/updates/inv-update-2025-04-02b

Roche provides update on Phase III OCREVUS high dose ... The rates of disability progression were low and consistent with rates observed in the previous pivotal studies of OCREVUS IV 600 mg. In ...