ABP 692 vs Ocrelizumab for Multiple Sclerosis

Recruiting at 16 trial locations

Overseen By Amgen Call Center

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Amgen

Must not be taking: Systemic corticosteroids, Immunosuppressants

Disqualifiers: Primary progressive MS, Secondary progressive MS, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The main objectives of the study are to demonstrate pharmacokinetics (PK) similarity between ABP 692 and Ocrelizumab (US), and ABP 692 and Ocrelizumab (EU), and to demonstrate pharmacodynamics (PD) similarity between ABP 692 and Ocrelizumab reference product (RP) based on assessment of the suppression of new active brain lesions over 24 weeks as assessed by magnetic brain imaging (MRI).

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications, but it mentions that certain medications might be prohibited. It's best to discuss your current medications with the trial team to see if they are allowed.

What data supports the effectiveness of the drug Ocrelizumab for treating multiple sclerosis?

Ocrelizumab has been shown to reduce relapse rates and disease activity in patients with relapsing multiple sclerosis and slow disease progression in primary progressive multiple sclerosis. It is generally well tolerated and provides the convenience of short, half-yearly infusions. ^{1 2 3 4 5}

How does the drug ABP 692 differ from Ocrelizumab for treating multiple sclerosis?

Ocrelizumab is a drug that targets B cells, which are part of the immune system and play a role in multiple sclerosis. It is unique because it was the first drug approved for early primary progressive multiple sclerosis, a form of the disease that previously had no specific treatments. ABP 692 is being compared to Ocrelizumab, but specific details about how it differs are not provided in the available research. ^{1 2 6 7 8}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

This trial is for individuals with Relapsing-Remitting Multiple Sclerosis (RRMS) as per McDonald Criteria. Participants should have a disability score that indicates they're still mobile and have had recent MS activity. They must be stable, without relapses in the last 28 days.

Inclusion Criteria

I have been diagnosed with RRMS according to the 2017 McDonald Criteria.

My disability level allows me to walk without aid or rest for at least 200 meters.

Evidence of recent MS activity as defined by the study protocol

Exclusion Criteria

I do not have any significant medical conditions.

I have a condition that needs long-term steroids or immunosuppressants.

My condition is diagnosed as primary or secondary progressive MS.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive initial doses of 300 mg IV infusion on Day 1 and Day 15, followed by a 600 mg IV infusion at Week 24

24 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

72 weeks

Periodic visits (in-person)

Treatment Details

Interventions

• ABP 692 (Monoclonal Antibodies)
• Ocrelizumab (Monoclonal Antibodies)

Trial Overview The study aims to compare ABP 692 with Ocrelizumab from the US and EU by looking at how similar their effects are on the body (PK) and their impact on brain lesions related to MS over six months, using MRI scans.

Participant Groups

Group I: Ocrelizumab (US)/ABP 692 Experimental Treatment 2 Interventions

Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (US) IV infusion on Day 1, followed by a second dose of 300 mg Ocrelizumab (US) IV infusion on Day 15. At Week 24, the treatment will switch to a 600 mg Ocrelizumab (US) IV infusion of ABP 692.

Group II: Ocrelizumab (EU) Experimental Treatment 1 Intervention

Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (EU) IV infusion on Day 1, followed by a 300 mg Ocrelizumab (EU) IV infusion on Day 15. At Week 24, participants will receive a dose of 600 mg Ocrelizumab (EU) IV infusion.

Group III: ABP 692 Experimental Treatment 1 Intervention

Participants affected by relapsing-remitting multiple sclerosis (RRMS) will receive an initial dose of 300 mg ABP 692 intravenous (IV) infusion on Day 1, followed by a second dose of 300 mg ABP 692 IV infusion on Day 15. A subsequent dose of 600 mg ABP 692 IV infusion will be administered 24 weeks after the initial dose.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Findings from Research

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]

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 an effective B-cell-targeted therapy for multiple sclerosis (MS), showing significant reductions in relapse rates and disability progression in both relapsing and primary progressive MS, based on data from multiple phase III trials involving human subjects.

Approved in March 2017, ocrelizumab is the first treatment specifically for primary progressive MS, with a recommended dosing of 600 mg intravenously every 6 months, though it may cause infusion-related reactions and infections as side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocrelizumab: A New B-cell Therapy for Relapsing Remitting and Primary Progressive Multiple Sclerosis. Stahnke, AM., Holt, KM.[2022]

In a study of 87 multiple sclerosis (MS) patients, those treated with ocrelizumab (OCR) showed a lower seroconversion rate (39.3%) after vaccination compared to 100% in MS patients not on disease-modifying therapies, indicating that OCR treatment may impair vaccine response.

The timing of vaccination relative to OCR infusion and the patient's B-cell count significantly influenced the humoral response, with better outcomes observed in patients vaccinated later and those with detectable B-cells, suggesting that vaccination timing should be carefully considered for OCR-treated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal humoral response after SARS-CoV-2 vaccination in ocrelizumab treated MS patients: To wait and repopulate? van Kempen, ZLE., Wieske, L., Stalman, EW., et al.[2022]

In a Phase IIIb study involving 141 patients, shorter-duration infusions of ocrelizumab (600 mg over 2 hours or 300 mg over 1.5 hours) were evaluated, resulting in a mean infusion time reduction of approximately 1.09 and 0.79 hours, respectively.

The rate of infusion-related reactions (IRRs) was mild-to-moderate, with no Grade 3-4 IRRs reported, indicating that shorter infusions do not compromise patient safety compared to standard infusion durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety results of administering ocrelizumab per a shorter infusion protocol in patients with primary progressive and relapsing multiple sclerosis. Vollmer, TL., Cohen, JA., Alvarez, E., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Ocrelizumab: First Global Approval. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Ocrelizumab for multiple sclerosis. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

The impact of ocrelizumab on health-related quality of life in individuals with multiple sclerosis. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Ocrelizumab: A Review in Multiple Sclerosis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

An exploratory analysis of the efficacy of ocrelizumab in patients with multiple sclerosis with increased disability. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Ocrelizumab: A New B-cell Therapy for Relapsing Remitting and Primary Progressive Multiple Sclerosis. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Longitudinal humoral response after SARS-CoV-2 vaccination in ocrelizumab treated MS patients: To wait and repopulate? [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Safety results of administering ocrelizumab per a shorter infusion protocol in patients with primary progressive and relapsing multiple sclerosis. [2022]