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Burfiralimab

A new clinical trial is underway to assess the effectiveness and safety of Burfiralimab (also known as hzVSF-v13) in treating moderate to severe Rheumatoid Arthritis (RA). This study aims to determine if adding Burfiralimab to standard disease-modifying antirheumatic drugs (DMARDs) can improve outcomes for patients who haven’t responded well to current treatments. The trial will compare different doses of Burfiralimab against a placebo to measure its impact on reducing disease activity and improving quality of life for RA patients.

Table of Contents

What is Burfiralimab?

Burfiralimab, also known as hzVSF-v13, is a new medication being studied for the treatment of moderate to severe rheumatoid arthritis (RA)[1]. It is classified as a humanized monoclonal antibody, which means it’s a type of protein designed to target specific parts of the immune system involved in RA[1].

How Does it Work?

While the exact mechanism of action is not fully described in the provided information, as a humanized monoclonal antibody, Burfiralimab likely works by targeting and modulating specific components of the immune system that are overactive in rheumatoid arthritis[1]. This targeted approach aims to reduce inflammation and alleviate symptoms associated with RA.

Clinical Trial Details

Burfiralimab is currently being studied in a Phase 2a clinical trial. This trial is designed to evaluate how well the drug works and how safe it is when added to standard rheumatoid arthritis treatments[1]. Here are some key details about the study:

  • It’s a multi-center study, meaning it’s being conducted at multiple hospitals or research centers.
  • It’s randomized, which means participants are randomly assigned to different treatment groups.
  • It’s double-blind and placebo-controlled, meaning neither the participants nor the researchers know who is receiving the actual drug or a placebo during the study. This helps ensure unbiased results.
  • The study lasts for 18 weeks, including a 4-week screening period and a 10-week treatment period[1].

Treatment Groups

The study includes three treatment groups[1]:

  1. Placebo group: Participants receive a placebo (a substance with no active medication) plus standard of care (SOC) treatment.
  2. Low-dose Burfiralimab group: Participants receive 200mg of Burfiralimab plus SOC treatment.
  3. High-dose Burfiralimab group: Participants receive 600mg of Burfiralimab plus SOC treatment.

The medication is given as an intravenous (IV) infusion every two weeks for 10 weeks[1].

Measuring Effectiveness

The main way the researchers are measuring how well Burfiralimab works is by looking at the ACR20 response at Week 12[1]. ACR stands for American College of Rheumatology, and ACR20 means:

  • At least 20% improvement in the number of swollen joints (out of 66 joints checked)
  • At least 20% improvement in the number of tender joints (out of 68 joints checked)

This measurement helps researchers understand if the medication is making a meaningful difference in reducing joint inflammation and pain[1].

Secondary Outcomes

The study is also looking at several other important factors to assess how well Burfiralimab works[1]:

  • Low Disease Activity (LDA): This is measured using different scoring systems like DAS28-CRP and CDAI, which take into account various aspects of the disease.
  • Remission: This means the disease is well-controlled with very low or no symptoms.
  • Physical function improvement: Measured using a questionnaire called HAQ-DI, which assesses how well patients can perform daily activities.
  • Pain relief: Measured using a pain scale.
  • Quality of life: Assessed using a questionnaire called EQ-5D-5L, which looks at overall health and well-being.

Potential Benefits

If Burfiralimab proves to be effective in this clinical trial, it could offer several potential benefits for people with moderate to severe rheumatoid arthritis[1]:

  • Reduced joint pain and swelling
  • Improved physical function and ability to perform daily activities
  • Better control of disease activity
  • Improved quality of life
  • A new treatment option for those who haven’t responded well to other medications

It’s important to note that these potential benefits are still being studied, and more research is needed to fully understand how well Burfiralimab works and its safety profile[1].

Aspect Details
Study Type Phase 2a, multi-center, randomized, double-blind, placebo-controlled
Drug Tested Burfiralimab (hzVSF-v13)
Condition Moderate to Severe Rheumatoid Arthritis
Treatment Groups 1) 200mg Burfiralimab + SOC
2) 600mg Burfiralimab + SOC
3) Placebo + SOC
Treatment Duration 10 weeks
Primary Outcome ACR 20 response at Week 12
Secondary Outcomes Low Disease Activity, Remission, Physical Function Improvement, Pain Relief, Quality of Life
Safety Assessment Up to 18 weeks

FAQ

  • What is Burfiralimab and how does it work? Burfiralimab, also known as hzVSF-v13, is a humanized monoclonal antibody. It's being studied as a potential treatment for moderate to severe Rheumatoid Arthritis. While the exact mechanism isn't detailed in the trial information, monoclonal antibodies generally work by targeting specific parts of the immune system to reduce inflammation and disease activity.
  • How is the Burfiralimab clinical trial structured? The trial is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study. Participants are divided into three groups: two groups receive different doses of Burfiralimab (200mg or 600mg) plus standard care, while the third group receives a placebo plus standard care. The treatment period lasts 10 weeks, with efficacy and safety assessments continuing up to 18 weeks.
  • Who can participate in this clinical trial? The trial is open to adults aged 18-80 years with moderate to severe Rheumatoid Arthritis who have not responded adequately to disease-modifying antirheumatic drug (DMARD) treatments. Both men and women can participate if they meet the eligibility criteria.
  • What are the main outcomes being measured in this trial? The primary outcome is the proportion of participants achieving a clinical response according to the ACR 20 criteria at Week 12. This means at least a 20% improvement in joint tenderness and swelling. Secondary outcomes include achieving low disease activity, remission, improved physical function, pain relief, and better health-related quality of life.
  • How is the safety of Burfiralimab being assessed? The safety of Burfiralimab is being assessed throughout the study, up to 18 weeks. While specific safety measures aren't detailed in the trial information, clinical trials typically monitor for adverse events, changes in laboratory values, and any other unexpected effects of the treatment.

Ongoing Clinical Trials on Burfiralimab

  • Study on Burfiralimab for Patients with Moderate to Severe Rheumatoid Arthritis

    Not recruiting

    2 1
    Investigated drugs:
    Austria Czechia Hungary The Netherlands Poland Spain

Glossary

  • Rheumatoid Arthritis (RA): A chronic inflammatory disorder that primarily affects joints, causing pain, swelling, and potential joint damage.
  • Disease-Modifying Antirheumatic Drugs (DMARDs): A class of drugs used to slow or stop the progression of rheumatoid arthritis by targeting the immune system.
  • Monoclonal Antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. In this case, Burfiralimab is a monoclonal antibody designed to target specific parts of the immune system involved in RA.
  • ACR 20: A measurement used in rheumatoid arthritis clinical trials, indicating a 20% improvement in the number of tender and swollen joints, as well as a 20% improvement in at least three of five other criteria.
  • DAS28-CRP: Disease Activity Score 28 – C-Reactive Protein, a measure of disease activity in rheumatoid arthritis that includes assessment of 28 joints and a blood test for inflammation.
  • CDAI: Clinical Disease Activity Index, a simplified measure of rheumatoid arthritis disease activity that doesn't require a blood test.
  • HAQ-DI: Health Assessment Questionnaire – Disability Index, a patient-reported outcome measure that assesses physical function in rheumatoid arthritis.
  • EuroQoL (EQ-5D-5L): A standardized measure of health-related quality of life that can be used to calculate quality-adjusted life years (QALYs).
  • Intravenous (IV) Infusion: A method of delivering medications directly into the bloodstream through a vein.
  • Placebo: An inactive substance that looks like the drug being tested but has no medical effect, used as a control in clinical trials.

References

  1. https://clinicaltrials.gov/study/NCT06306339