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Study of Peresolimab for Adults with Moderate to Severe Rheumatoid Arthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The treatment being tested is called Peresolimab (also known by its code name LY3462817), which is a type of medication known as a humanised IgG1 monoclonal antibody against PD-1. This medication is designed to help the immune system work better in managing the symptoms of rheumatoid arthritis. In this study, some participants will receive Peresolimab, while others will receive a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate how effective Peresolimab is compared to a placebo in improving the symptoms of rheumatoid arthritis. Participants in the study will receive the treatment through a solution for infusion, which means the medication is given directly into the bloodstream. The study will last for a period of time, during which participants will be monitored to see how their symptoms change. The goal is to see if Peresolimab can help achieve a 20% improvement in symptoms, as defined by the American College of Rheumatology (ACR)20 criteria.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how well the treatment works. The study is designed to provide valuable insights into the potential benefits of Peresolimab for people living with rheumatoid arthritis, with the hope of offering a new option for managing this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on your diagnosis of rheumatoid arthritis for at least 3 months.
You will receive detailed information about the study, including the procedures, potential risks, and benefits. You will have the opportunity to ask any questions you may have.
Step 2
Baseline assessment
A baseline assessment will be conducted to evaluate your current health status and the severity of your rheumatoid arthritis. This may include physical examinations, blood tests, and questionnaires.
These assessments are important to establish a starting point for measuring the effects of the treatment.
Step 3
Treatment administration
You will receive the study medication, which is a humanised igg1 monoclonal antibody against pd-1, administered as a subcutaneous injection. This means the medication is injected under the skin.
The dosage and frequency of the injections will be determined by the study protocol, and you will be informed about the schedule during your visits.
Step 4
Regular follow-up visits
You will attend regular follow-up visits to monitor your response to the treatment and any side effects. These visits will include physical examinations, blood tests, and questionnaires similar to the baseline assessment.
The frequency of these visits will be explained to you, and it is important to attend all scheduled appointments to ensure your safety and the accuracy of the study results.
Step 5
Final assessment
At the end of the study period, a final assessment will be conducted. This will involve similar procedures to the baseline assessment to evaluate any changes in your condition.
The results of this assessment will help determine the effectiveness of the treatment in achieving a 20% improvement in the American College of Rheumatology core set values, known as ACR20.

Who can join the trial?

4 criteria

Must have a diagnosis of adult onset rheumatoid arthritis for at least 3 months. Rheumatoid arthritis is a condition that causes pain and swelling in the joints.
Open to both male and female participants.
Participants must be within the specified age range for the study. This typically means adults, but the exact ages are not specified here.
Includes individuals from vulnerable populations. This means people who might need extra protection or care when participating in a study.

Who cannot join the trial?

9 criteria

Patients with any other **autoimmune diseases** besides rheumatoid arthritis cannot participate. Autoimmune diseases are conditions where the body's immune system mistakenly attacks its own tissues.
Patients who have had a recent infection or are currently experiencing an infection are not eligible.
Patients who have received any **live vaccines** within the last 4 weeks cannot join. Live vaccines contain a small amount of the living virus or bacteria.
Patients with a history of **cancer** in the last 5 years, except for certain skin cancers, are excluded. Cancer is a disease where cells in the body grow uncontrollably.
Patients who are currently pregnant or breastfeeding are not allowed to participate.
Patients with a history of **substance abuse** or alcohol abuse in the past year are excluded. Substance abuse refers to the harmful use of substances like drugs or alcohol.
Patients who have participated in another clinical trial within the last 30 days cannot join this study.
Patients with **severe heart disease** or other serious health conditions that could interfere with the study are not eligible. Heart disease refers to various types of heart conditions.
Patients who are unable to comply with the study procedures or follow the study schedule are excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
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Centro Ricerche Cliniche Di Verona S.r.l.
Verona, Italy
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Hippokration Hospital
Athens, Greece

Trial locations

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Investigated drugs

Peresolimab is a medication being studied for its potential to help people with rheumatoid arthritis, a condition that causes pain and swelling in the joints. This medication is designed to reduce the activity of the immune system, which is often overactive in people with rheumatoid arthritis. By doing so, it aims to decrease the inflammation and pain associated with the disease, helping patients feel better and improve their ability to move and perform daily activities. The study is focused on understanding how well this medication works compared to not taking it at all.

What is already known about the treatment

Peresolimab – Peresolimab is administered as an injection, typically under the skin, and is currently being studied in clinical trials for its effectiveness in treating rheumatoid arthritis, a condition that causes pain and swelling in the joints. This medication is still under investigation, and its full potential and safety profile are being evaluated in medical research. It is primarily intended for people with moderately-to-severely active rheumatoid arthritis, aiming to reduce symptoms and improve joint function. Peresolimab works by modulating the immune system to decrease inflammation, which is a key factor in rheumatoid arthritis. It belongs to a class of drugs known as immunomodulators, which help regulate the immune response to prevent excessive inflammation.

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically begins with inflammation of the synovial membrane, leading to swelling and pain. Over time, the inflammation can cause damage to the cartilage and bone within the joint. This damage can result in joint deformity and loss of function. The disease often progresses symmetrically, affecting the same joints on both sides of the body. It can also cause systemic symptoms, such as fatigue and fever.