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A study to evaluate the safety and effectiveness of VTX2735 sodium in patients with recurrent pericarditis

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What is this trial about?

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

This study focuses on individuals living with Recurrent Pericarditis, a condition where the thin sac surrounding the heart becomes inflamed multiple times. The research aims to evaluate the safety and tolerability of a new medication called VTX2735. This medication is administered as an oral modified-release tablet, which is a type of pill designed to release the medicine into the body at a controlled rate over a period of time.

During the study, participants will receive the study drug to observe how it affects the body and how well it is tolerated. The investigation will monitor how the medicine moves through the system and its impact on certain biological markers, such as hs-CRP, which is a blood test used to measure inflammation in the body. The process involves regular observations to track any changes in symptoms or physical reactions following the administration of the treatment.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment phase

    The treatment phase involves taking vtx2735 sodium, which is a modified-release tablet. this type of tablet is designed to release the medicine into the body at a controlled rate. the medication is taken by mouth.

    The safety and tolerability, which refers to how well the body handles the medicine, are monitored from the first dose through the end of the follow-up period.

  2. Step 2

    Monitoring and assessment

    During the first 6 weeks, assessments are made regarding the nrs, which is a scale used to measure pain intensity.

    Changes in hs-crp levels are also measured. hs-crp is a blood test that checks for inflammation, which is the body's response to injury or infection.

    The incidence and severity of adverse events, which are any unwanted medical occurrences, are recorded throughout the study.

  3. Step 3

    Follow-up

    The follow-up period occurs after the medication has been taken to monitor for any continuing effects or adverse events.

Who can join the trial?

14 criteria

  • You must be a man or a woman between the ages of 18 and 75 years old.
  • You must have a history of recurrent pericarditis, which is a condition where the sac surrounding the heart becomes inflamed multiple times.
  • A doctor must confirm that your previous heart inflammation met specific medical standards, such as having pericarditic chest pain, a pericardial rub (a specific sound heard through a stethoscope), changes seen on an ECG (a test that records the electrical activity of the heart), or a pericardial effusion (an abnormal buildup of fluid around the heart).
  • You must be experiencing an ongoing episode of symptoms or be at risk of having a new episode during the screening period.
  • Your CRP (a blood test that measures inflammation, or how your body is reacting to irritation or injury) must be greater than 10 mg/L, or if it is lower, you must be taking corticosteroids (medicine that reduces inflammation) and have evidence of heart inflammation seen on an MRI (a detailed medical imaging scan).
  • Your pain level must be at least a 4 out of 11 on the NRS (a scale used to measure how much pain you are feeling).
  • If you take NSAIDs (painkillers like ibuprofen), colchicine (a medicine used to reduce inflammation), or oral corticosteroids (pills that reduce swelling and inflammation), your doses must be stable for at least 3 to 7 days before starting the study.
  • You must agree to keep your current medication doses the same for at least the first 6 weeks of the study.
  • You must agree not to make any major changes to your lifestyle, such as starting a new diet or a new exercise routine, during the study.
  • Male participants must agree not to donate sperm and must use a condom; female partners should also use a highly effective form of birth control.
  • Female participants must not be pregnant or breastfeeding.
  • Women who are of childbearing potential must either not be able to become pregnant or must use a highly effective form of birth control (with a failure rate of less than 1% per year) during the study and for 30 days after the last dose.
  • Women who can become pregnant must have a negative serum pregnancy test (a blood test to check for pregnancy) and must not donate oocytes (eggs) for at least 90 days after the study ends.
  • You must be able to provide informed consent, which means you understand and agree to all the details and rules of the study.

Who cannot join the trial?

21 criteria

  • You cannot participate if your pericarditis (inflammation of the sac around the heart) was caused by tuberculosis (a serious bacterial infection), cancer, pus from an infection, radiation, a blunt injury to the chest (like a car accident), myocarditis (inflammation of the heart muscle), or certain autoimmune diseases (where the body's immune system attacks itself), except for Still’s disease.
  • You cannot participate if you have had cancer in any part of your body within the last 5 years, unless it was a specific type of skin cancer, certain prostate cancer, or a very early stage of cervical cancer that has been fully treated or is stable.
  • You cannot participate if you have a current significant infection or a history of long-term infections, such as infections in the kidneys, chest, sinuses, or urinary tract, or if you have an open, infected skin wound.
  • You cannot participate if you have taken oral antibiotics (pills) in the last 2 weeks, or if you were hospitalized, had a serious infection, or received IV antibiotics (medicine given through a vein) in the last 2 months.
  • You cannot participate if you have had an organ transplant.
  • You cannot participate if you have a history of drug or chemical abuse within the last 2 years, or alcohol abuse, including drinking a high amount of alcohol in the last 6 months.
  • You cannot participate if you have other serious heart problems that could make the study unsafe or make it hard to read the results, such as a heart attack, unstable angina (chest pain), heart failure, blood clots (thrombosis) in the arteries or veins, or a stroke in the last 6 months.
  • You cannot participate if you have used any medicine that targets the NLRP3 pathway (a part of the immune system) before.
  • You cannot participate if your blood tests show abnormal levels of: white blood cells, neutrophils (a type of white blood cell), lymphocytes (a type of white blood cell), platelets (cells that help blood clot), hemoglobin (protein in red blood cells that carries oxygen), liver enzymes (AST or ALT), bilirubin (a yellow substance in the blood), kidney function (eGFR), Hepatitis B or Hepatitis C, tuberculosis, or HIV.
  • You cannot participate if a urine drug test is positive for drugs without a medical explanation.
  • You cannot participate if your heart's electrical timing, known as the QTcF interval, is longer than the safe limit during testing.
  • You cannot participate if you have uncontrolled high blood pressure (hypertension), defined as a top number higher than 160 or a bottom number higher than 100.
  • You cannot participate if you have a history of immune system disorders that affect your body's ability to fight infection or change your CRP (a marker of inflammation in the blood).
  • You cannot participate if you are allergic to any of the ingredients used to make the study medicine.
  • You cannot participate if you are pregnant or breastfeeding.
  • You cannot participate if you have received another experimental medicine or device within the last 30 days or plan to use one during the study.
  • You cannot participate if you have used immunosuppressants (medicines that lower the immune system) within the last 6 months, or specific biologic therapies (targeted immune medicines) within the last 12 weeks.
  • You cannot participate if you have used certain immune-targeting medicines like rilonacept or anakinra within a specific timeframe before the study starts.
  • You cannot participate if you have used any injected steroids (a type of anti-inflammatory medicine) within the last 4 weeks.
  • You cannot participate if you have a history of blood disorders (myeloproliferative disorder) or nerve/brain diseases like multiple sclerosis.
  • You cannot participate if you have received a live vaccine in the last 28 days or a COVID-19 vaccine in the last 14 days.
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Investigated drugs

VTX2735 is an experimental medication being tested to see if it is safe and effective for people who experience repeated episodes of inflammation around the heart, a condition known as recurrent pericarditis.

What is already known about the treatment

VTX2735 sodium - This medication is taken orally in the form of a tablet designed to release the drug slowly into the body over time. Currently being studied in clinical trials, it is being investigated as a potential treatment for people who suffer from repeated inflammation of the sac surrounding the heart, known as recurrent pericarditis. At a molecular level, it works by targeting and blocking specific proteins that trigger inflammation, acting as a specialized type of immune system regulator. It is classified as an investigational anti-inflammatory drug.

Investigated diseases

Recurrent Pericarditis - This condition involves repeated episodes of inflammation in the sac that surrounds the heart. The inflammation causes irritation and pain in the chest area. These episodes tend to occur periodically, with periods of relative calm between them. Each new occurrence follows a previous episode of inflammation. The condition is characterized by the recurring nature of the heart sac swelling.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IITrial ID2025-524784-20-00Protocol codeVTX2735-202Estimated enrolment39 patientsSponsorZomagen Biosciences Limited

sourced from the EU Clinical Trials Register and site verification

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