AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase 2a, Open-Label Pilot Study to Evaluate the Safety/Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of VTX2735 in Participants with Recurrent Pericarditis

This research is an early study (Phase 2a) to explore a new potential medicine called VTX2735 for people who suffer from recurrent pericarditis. This condition causes repeated inflammation of the sac around the heart. The main goals are to see how safe the new medicine is and if it causes any unwanted side effects. We'll also be looking at how well the medicine works to help with the symptoms and how the body processes it. This initial study will help us understand if VTX2735 could be a helpful treatment option in the future for this challenging condition.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Zomagen Biosciences Limited

Enrolment target

Start

27 Feb 2026

Recurrent Pericarditis

What is this study about?

This clinical trial is designed to investigate a new potential treatment, VTX2735, for a condition called recurrent pericarditis. Pericarditis happens when the thin sac around your heart (called the pericardium) becomes inflamed, causing chest pain and other symptoms. For some people, this inflammation keeps coming back, which is known as recurrent pericarditis.

In this study, researchers are focusing on several important aspects. First and foremost, they want to understand how safe VTX2735 is and what side effects, if any, it might cause. They'll be carefully monitoring participants from the very first dose right through to the end of the study's follow-up period. This safety information is crucial for any new medicine.

Beyond safety, the study also aims to see how effective VTX2735 might be. They will be looking at how participants' symptoms change over time, specifically measuring pain levels and a marker of inflammation in the blood called hs-CRP. This information will help doctors understand if VTX2735 could reduce inflammation and improve the quality of life for people with recurrent pericarditis.

Key takeaways

This study is testing a new medicine, VTX2735, for recurring pericarditis.
The main goals are to check the medicine's safety and how well it works.
Researchers will monitor side effects and changes in your symptoms and inflammation.
It's an early-stage study, so it's about learning more about the new treatment.
Participation involves regular clinic visits for checks, blood tests, and symptom tracking.

Who may be eligible?

To join this study, you would need to have a diagnosis of recurrent pericarditis. The study is open to both men and women, and there are no specific age limits mentioned, meaning adults of various ages might be able to take part.

Generally, participants need to be well enough to safely take part in the study and commit to the study schedule. There would also be specific medical requirements related to your pericarditis, for example, how often your attacks occur or how you responded to previous treatments.

Before you can join, a study doctor would review your medical history and perform some checks to make sure the study is a good and safe option for you. They will explain everything in detail if you are interested.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a diagnosis of recurrent pericarditis?
Am I generally well enough to participate in a study?
Am I able to attend regular clinic appointments?
Am I comfortable with receiving a new, investigational medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, VTX2735. This is an "open-label" study, which means both you and the study team would know you are receiving VTX2735 (it's not a placebo). Your participation would involve several visits to the clinic where you would have health checks, blood tests, and answer questions about your symptoms, especially regarding your pain levels. These visits would allow the research team to monitor your health, check for any side effects, and see how the medicine is working. The study would last for a specific period, with initial treatment and then a follow-up period to ensure your well-being after treatment finishes. The total duration of your involvement, including all visits and follow-up, would be clearly explained before you start.

Potential risks and benefits

Taking part in a study like this means you would be among the first to try a new potential treatment for recurrent pericarditis. While there's no guarantee the medicine will help you personally, it could potentially improve your symptoms or help doctors learn more about your condition. However, like all medicines, VTX2735 may have side effects, which the study team will monitor closely. You will be told about all the known and potential risks before you decide to join. Remember, taking part in a study is always voluntary, and you have the right to withdraw at any time without giving a reason, and it won't affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is recurrent pericarditis?

It's when the protective sac around your heart gets inflamed repeatedly, causing symptoms like chest pain.

What is VTX2735?

It's a new medicine being tested in this study to see if it can help treat recurrent pericarditis.

Will I get a placebo (dummy drug) in this study?

No, this is an 'open-label' study, meaning everyone involved will know you are receiving VTX2735.

How long will I need to be involved in the study?

The study team will explain the exact duration, including treatment and follow-up, before you start.

Who can join this study?

People with recurrent pericarditis, both men and women, can be considered. Further checks will confirm if you're suitable.