Ocrelizumab Formulations for Multiple Sclerosis

(PORTAMENTO Trial)

Recruiting at 12 trial locations

Overseen By Reference Study ID Number: CN45320 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must not be taking: Systemic corticosteroids, Immunosuppressants

Disqualifiers: Cancer, Immunocompromised, Cardiovascular, 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

Compensation: Varies

Number of Visits: 1

182 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two formulations of ocrelizumab, a medication for multiple sclerosis (MS), to determine if they function similarly in the body. It targets individuals with either relapsing MS, where symptoms fluctuate, or primary progressive MS, where symptoms progressively worsen without relapses. Participants will initially receive one formulation and then switch to the test version. Those with MS symptoms matching these patterns, who have not received certain treatments in the past two years, might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot participate if you have a condition that requires ongoing treatment with certain drugs like systemic corticosteroids or immunosuppressants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ocrelizumab, a treatment for multiple sclerosis, is generally well-tolerated. Studies have found that the most common side effect is a reaction at the injection site, occurring in about 49% of patients. These reactions are usually mild, such as a rash or slight itchiness.

Ocrelizumab has been used in many trials and real-world settings for years. Safety reviews have tracked patients for over seven years and have not identified any new safety concerns. Both the original and new versions of the drug exhibit similar side effects in terms of type and frequency.

Overall, long-term use of ocrelizumab in people with multiple sclerosis suggests it is a safe treatment option. However, monitoring side effects remains important, especially when trying new versions of the drug. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Ocrelizumab is unique because it offers a subcutaneous (SC) injection option for treating multiple sclerosis (MS), which is different from the standard intravenous (IV) method. This new delivery method could make it easier and more convenient for patients to manage their treatment at home. Researchers are excited because it maintains the efficacy of the traditional IV formulation while potentially reducing the time and resources needed for administration. By providing more flexibility, this SC formulation could improve the overall quality of life for people living with MS.

What evidence suggests that this trial's treatments could be effective for multiple sclerosis?

Research shows that ocrelizumab effectively manages multiple sclerosis, a disease affecting the brain and spinal cord. Studies have found that ocrelizumab significantly reduces relapses and slows symptom progression in people with relapsing multiple sclerosis (RMS). Over 5.5 years, it has outperformed many other treatments in managing these symptoms. For primary progressive multiple sclerosis (PPMS), ocrelizumab has also shown positive results by lowering the risk of worsening disability compared to a placebo. In this trial, participants will receive either the test or reference formulation of ocrelizumab. Previous studies have demonstrated similar effectiveness for both versions, providing strong evidence for their use in treating multiple sclerosis. ^{5 6 7 8 9}

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 individuals with Multiple Sclerosis (either relapsing or primary progressive types) who meet specific diagnostic criteria and have a disability status score of 0-6.5. Participants will be tested to ensure they fit these conditions before joining the study.

Inclusion Criteria

My diagnosis is RMS or PPMS based on the latest McDonald criteria.

My disability level allows me to walk at least with assistance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Controlled Phase

Participants receive one dose of either the test or reference formulation of ocrelizumab

1 day

1 visit (in-person)

Continuation Phase

All participants receive ocrelizumab SC test formulation as per a pre-defined dosing regimen

Variable, based on dosing regimen

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ocrelizumab

Trial Overview The study is testing if a new subcutaneous formulation of Ocrelizumab (a medication used in MS treatment) is equivalent to the existing marketed version. Participants will receive one dose from either the test or reference formulation, followed by continued doses from the test formulation.

How Is the Trial Designed?

Group I: Ocrelizumab Test Formulation Experimental Treatment 1 Intervention

Participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the controlled phase and continuation phase.

Group II: Ocrelizumab Reference Formulation Active Control 2 Interventions

Participants will receive ocrelizumab reference formulation, 920 mg, as SC injection, on Day 1 during the controlled phase. Thereafter, participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the continuation phase.

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11406495/

Five-year efficacy outcomes of ocrelizumab in relapsing ... OCR demonstrates superiority in controlling relapses and disability progression in RMS compared with real-world treatment pathways over a 5.5-year period.

2. 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 ...

3. neurology.org neurology.org/doi/10.1212/WNL.0000000000213574

Subcutaneous Ocrelizumab in Patients With Multiple ... This study provides Class II evidence that a single SC injection of 920 mg of OCR achieves a noninferior 12-week area under serum concentration–time curve.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923020093

Effectiveness of Ocrelizumab in Primary Progressive ... This multicenter retrospective study collected data about the effectiveness of ocrelizumab in PPMS patients who received treatment between May 2017 and June ...

5. msard-journal.com msard-journal.com/article/S2211-0348(22)00616-2/fulltext

Final results from the PRO-MSACTIVE study Efficacy, safety and patient reported outcomes in patients with active relapsing multiple sclerosis treated with ocrelizumab: Final results from ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf

OCREVUSTM (ocrelizumab) injection - accessdata.fda.gov OCREVUS is a prescription medicine used to treat adults with relapsing or primary progressive forms of multiple sclerosis. It is not known if OCREVUS is safe or ...

7. genentech-medinfo.com genentech-medinfo.com/our-products/neuroscience/ocrevus.html

Ocrelizumab | Genentech Prescribing & Product Information The Prescribing Information is the primary source of information on the known and potential risks of ocrelizumab for relapsing forms of multiple sclerosis (RMS)

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8548959/

Safety of Ocrelizumab in Patients With Relapsing and ... To report safety of ocrelizumab (OCR) up to 7 years in patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) ...

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

Safety | OCREVUS® (ocrelizumab) The most common adverse reaction observed with OCREVUS ZUNOVO in patients with RMS and PPMS was injection reactions (incidence of 49%).