#1 Clinical Trials Search in Europe

Humanised Igg1 Monoclonal Antibody Against Pd-1

A new drug called peresolimab (LY3462817) is being studied in clinical trials for the treatment of moderate to severe rheumatoid arthritis. This drug is a humanized IgG1 monoclonal antibody that targets PD-1, a protein involved in immune system regulation. The ongoing Phase 2b study aims to evaluate the safety and effectiveness of peresolimab compared to a placebo in adults with rheumatoid arthritis.

Table of Contents

What is Peresolimab?

Peresolimab, also known by its code name LY3462817, is a new medication being studied for the treatment of rheumatoid arthritis. It is classified as a humanised IgG1 monoclonal antibody that targets a specific protein in the body called PD-1.[1]

To break this down:

  • Humanised means the antibody is designed to be similar to human antibodies, reducing the chance of the body rejecting it.
  • IgG1 refers to a type of antibody that our immune system naturally produces.
  • Monoclonal antibody means it’s a laboratory-made protein that can bind to specific substances in the body.
  • PD-1 (Programmed Cell Death protein 1) is a protein involved in regulating the immune system.

Target Condition: Rheumatoid Arthritis

Peresolimab is being developed to treat moderate to severe rheumatoid arthritis in adults. Rheumatoid arthritis is an autoimmune disease where the body’s immune system mistakenly attacks the joints, causing inflammation, pain, and potentially long-term damage.[1]

How Peresolimab Works

While the exact mechanism isn’t fully detailed in the trial information, we can infer that peresolimab likely works by targeting the PD-1 protein. In autoimmune diseases like rheumatoid arthritis, modulating the activity of PD-1 might help regulate the overactive immune response that causes joint inflammation and damage.

Clinical Trial Details

Peresolimab is currently being studied in a Phase 2b clinical trial. This means it’s in a relatively early stage of testing in humans, where researchers are trying to determine its effectiveness and safety. The main goal of this study is to see if peresolimab is better than a placebo in helping patients achieve what’s called an ACR20 response.[1]

ACR20 is a standard measure used in rheumatoid arthritis trials. It indicates a 20% improvement in the number of tender and swollen joints, along with a 20% improvement in at least three of five other measures of disease activity.

Eligibility Criteria

To participate in this study, patients must meet certain criteria:

Inclusion Criteria:

  • Adults diagnosed with rheumatoid arthritis for at least 3 months[1]

Exclusion Criteria:

  • History of cancer within the last 5 years (with some exceptions for certain skin cancers and cervical cancer)[1]
  • Cervical dysplasia (abnormal cells on the surface of the cervix)[1]
  • Certain types of infections within the last 3 months[1]
  • Current hepatitis B or C infection[1]

Administration and Dosage

Peresolimab is administered as a solution for infusion, which means it’s given directly into the bloodstream through an IV. However, the trial information also mentions subcutaneous injection as a route of administration, suggesting that it might be given as an injection under the skin in some cases.[1]

The maximum daily dose mentioned in the trial is 36 mg, with a maximum total dose of 15,000 mg over a treatment period of up to 60 weeks.[1]

Potential Benefits

If successful, peresolimab could offer a new treatment option for people with moderate to severe rheumatoid arthritis. It might be particularly helpful for patients who haven’t responded well to existing treatments. However, it’s important to remember that the drug is still in the testing phase, and more research is needed to confirm its safety and effectiveness.

Aspect Details
Drug Name Peresolimab (LY3462817)
Drug Type Humanized IgG1 monoclonal antibody against PD-1
Condition Studied Moderate to severe rheumatoid arthritis
Trial Phase Phase 2b
Main Objective Evaluate efficacy in achieving ACR20 compared to placebo
Administration Method Subcutaneous injection
Maximum Daily Dose 36 mg
Maximum Total Dose 15,000 mg
Maximum Treatment Period 60 weeks
Key Inclusion Criteria Adult-onset rheumatoid arthritis for at least 3 months
Key Exclusion Criteria Recent cancer history, certain infections, hepatitis B or C

FAQ

  • What is peresolimab? Peresolimab (LY3462817) is a humanized IgG1 monoclonal antibody that targets PD-1, a protein involved in immune system regulation. It is being studied as a potential treatment for moderate to severe rheumatoid arthritis.
  • What is the main goal of this clinical trial? The main objective of this clinical trial is to evaluate the efficacy of peresolimab compared to placebo in achieving ACR20, which represents a 20% improvement in rheumatoid arthritis symptoms.
  • Who can participate in this clinical trial? Adults who have been diagnosed with rheumatoid arthritis for at least 3 months and have moderate to severe symptoms may be eligible to participate. However, there are specific exclusion criteria, such as recent cancer history or certain infections.
  • How is peresolimab administered? Peresolimab is administered through subcutaneous injection, which means it is injected under the skin.
  • What are the potential benefits of participating in this trial? Participants may benefit from receiving a potentially effective treatment for their rheumatoid arthritis. Additionally, they contribute to the advancement of medical knowledge and the development of new treatments for this condition.

Ongoing Clinical Trials on Humanised Igg1 Monoclonal Antibody Against Pd-1

  • Study of Peresolimab for Adults with Moderate to Severe Rheumatoid Arthritis

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Greece Hungary Italy Poland Spain

Glossary

  • Rheumatoid Arthritis: A chronic autoimmune disease that causes inflammation, pain, and stiffness in the joints, particularly in the hands and feet.
  • Monoclonal Antibody: A type of protein made in the laboratory that can bind to specific targets in the body, such as certain cells or proteins. In this case, peresolimab targets PD-1.
  • PD-1: Programmed cell death protein 1, a protein that plays a role in regulating the immune system's response.
  • ACR20: A measure used in rheumatoid arthritis clinical trials that indicates a 20% improvement in the number of tender and swollen joints, as well as other core set measures.
  • Subcutaneous Injection: A method of administering medication by injecting it into the layer of tissue between the skin and muscle.
  • Placebo: An inactive substance that looks like the drug being tested but has no medical effect. It is used as a comparison to evaluate the effectiveness of the actual drug.
  • Phase 2b Trial: A stage of clinical research that further evaluates the safety and effectiveness of a drug in a larger group of patients with the target condition.
  • Efficacy: The ability of a treatment to produce the desired beneficial effect under ideal circumstances.

References

  1. http://clinicaltrials.eu/trial/study-of-peresolimab-for-adults-with-moderate-to-severe-rheumatoid-arthritis/