VTX2735 for Pericarditis

Recruiting at 14 trial locations

Overseen By Ventyx Clinical Trial Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Zomagen Biosciences Ltd.

Must be taking: NSAIDs, Colchicine, Corticosteroids

Disqualifiers: Tuberculosis, Trauma, Tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new treatment, VTX2735, is safe and effective for individuals with Recurrent Pericarditis (RP), a condition characterized by repeated inflammation of the heart's lining. Participants will receive varying doses of the treatment over several weeks to evaluate its efficacy and potential side effects. Individuals who have previously experienced pericarditis and are currently experiencing symptoms, or anticipate them soon, may be suitable candidates for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can be on stable doses of NSAIDs, colchicine, and/or oral corticosteroids.

Is there any evidence suggesting that VTX2735 is likely to be safe for humans?

Research shows that VTX2735, a treatment under study for recurrent pericarditis (inflammation of the tissue around the heart), is designed to be safe and easy to tolerate. This treatment blocks certain proteins in the body that cause inflammation. In earlier studies with patients who have recurrent pericarditis, VTX2735 showed promise in managing symptoms without causing serious side effects.

Although specific safety details from these studies are not provided here, the research is in a later stage, indicating some evidence supports its safety in humans. Additionally, VTX2735 is taken as a pill, which may be more convenient for patients compared to injections. Overall, the treatment appears to be a promising option for those with recurrent pericarditis, but more data will help confirm its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pericarditis?

Unlike the standard treatments for pericarditis, which often include anti-inflammatory drugs and colchicine, VTX2735 might offer a new approach by targeting specific inflammatory pathways directly. Researchers are excited about VTX2735 because it has a novel mechanism of action that could potentially reduce inflammation more effectively and with fewer side effects. This treatment is particularly promising as it might provide quicker relief and better long-term management for patients suffering from pericarditis compared to existing therapies.

What evidence suggests that VTX2735 might be an effective treatment for Recurrent Pericarditis?

Research has shown that VTX2735 could be a promising treatment for recurrent pericarditis, a condition where the heart's lining becomes repeatedly inflamed. This trial will evaluate VTX2735 across different treatment groups, including Cohort A, Cohort B Treatment Group B1, and Cohort B Treatment Group B2. VTX2735 blocks a part of the immune system called the NLRP3 inflammasome, which can cause inflammation. By stopping this process, VTX2735 aims to reduce inflammation and symptoms. Although limited data exists on its effectiveness in humans, this approach offers hope for managing recurrent pericarditis symptoms. Early studies focus on ensuring the medication is safe and well-tolerated by patients, which are crucial first steps in understanding its full potential. ^{1 3 4 6 7}

Who Is on the Research Team?

Henrik Sonnergren, MD, PhD

Principal Investigator

Ventyx Biosciences

Are You a Good Fit for This Trial?

This trial is for individuals with Recurrent Pericarditis, which means they've had multiple episodes of pericarditis. Participants must pass a screening to qualify and be willing to take the study drug VTX2735 over several weeks.

Inclusion Criteria

My doses of NSAIDs, colchicine, or steroids are stable.

Capable of giving signed informed consent and able to comply with the protocol

I have had a previous episode of acute pericarditis.

Exclusion Criteria

Clinically important history of a medical disorder that would compromise safety or data quality, per the Investigator's judgment

I have had pericarditis not caused by TB, injury, cancer, heart inflammation, or autoimmune diseases.

I have a history of significant immune system disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive active Dose A of VTX2735

6 weeks

Extension Treatment

Participants meeting criteria continue receiving active Dose A

7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VTX2735

Trial Overview

The trial is testing the safety and effectiveness of a medication called VTX2735 in treating Recurrent Pericarditis. Patients will receive this drug during an initial treatment period followed by an extension phase if they meet certain criteria.

How Is the Trial Designed?

Group I: Cohort B Treatment Group B2 Experimental Treatment 1 Intervention

Group II: Cohort B Treatment Group B1 Experimental Treatment 1 Intervention

Group III: Cohort A Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Zomagen Biosciences Ltd.

Lead Sponsor

Trials

4

Recruited

210+

Published Research Related to This Trial

In a study of 238 patients with acute pericarditis, urgent coronary angiography was performed in 16.8% of cases, with a significantly higher frequency (24.7%) in patients exhibiting ST-segment elevation on their electrocardiograms.

Coronary angiography revealed that 35% of patients undergoing the procedure had mild to moderate coronary artery disease, highlighting the importance of careful assessment in patients with symptoms suggestive of both pericarditis and coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and predictors of urgent coronary angiography in patients with acute pericarditis. Salisbury, AC., Olalla-Gómez, C., Rihal, CS., et al.[2023]

Patients with idiopathic pericarditis showed a seasonal pattern of diagnosis, with all cases occurring between April and August, and had a lower prevalence of previous diseases compared to those with secondary pericarditis.

The study found that idiopathic pericarditis patients responded well to treatment with non-steroidal anti-inflammatory drugs (NSAIDs), with 82.6% receiving them, while only 8.2% of patients with secondary pericarditis were treated this way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pericarditis. Series of 84 consecutive cases. Zanettini, MT., Zanettini, JO., Zanettini, JP.[2019]

A T-wave amplitude of 0.3 mV or less in lead V6 is a strong indicator for diagnosing acute pericarditis, with a positive predictive value (PPV) and negative predictive value (NPV) of 0.85, based on a study of 19 patients with acute pericarditis.

The ST/T ratio in lead V6, specifically a ratio of 0.25 or greater, was found to be the most reliable measure for distinguishing acute pericarditis from normal variant ST-T changes, achieving a perfect PPV and NPV of 1.0.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The differential diagnosis of acute pericarditis from the normal variant: new electrocardiographic criteria. Ginzton, LE., Laks, MM.[2023]

Non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are the primary treatments for pericarditis, effectively reducing inflammation in most cases.

For specific conditions like autoimmune disorders or malignant pericarditis, targeted therapies such as intrapericardial triamcinolone or cisplatin can be effective with minimal side effects, highlighting the importance of tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New possibilities of diagnostics and therapy of pericarditis]. Maisch, B., Karatolios, K.[2021]

Recent studies, including the first randomized trials, are beginning to provide evidence-based guidelines for the treatment of pericarditis, which has traditionally relied on empirical methods.

The main treatments recommended include medium-to-high doses of aspirin or NSAIDs, with corticosteroids used sparingly and colchicine recommended to reduce recurrence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized therapy for pericarditis. Imazio, M., Brucato, A., Trinchero, R., et al.[2014]

Citations

1.

ir.ventyxbio.com

ir.ventyxbio.com/news-releases/news-release-details/ventyx-biosciences-reports-third-quarter-2025-financial-results

Ventyx Biosciences Reports Third Quarter 2025 Financial ...

VTX2735 in Recurrent Pericarditis (Data Expected Q4 2025): The multicenter, Phase 2, open-label trial is evaluating VTX2735 in patients with ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06836232

NCT06836232 | An Open-Label Pilot Study of VTX2735 in ...

This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP). Cohort A will include up to 30 ...

3.

mayo.edu

mayo.edu/research/clinical-trials/cls-20581201

Phase 2a Open-Label Pilot Study Of VTX2735 In Recurrent ...

The purpose of this study is to evaluate the safety and tolerability of VTX2735 in participants with symptomatic recurrent pericarditis.

4.

trial.medpath.com

trial.medpath.com/clinical-trial/5ed2172f30452740/nct06836232-vtx2735-recurrent-pericarditis-study

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP).

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352906725002441

Pericarditis at the crossroads: Unlocking the next wave of ...

VTX2735 is an oral small-molecule inhibitor of NLRP3 currently entering phase II trials for recurrent pericarditis. By preventing inflammasome assembly, VTX2735 ...

6.

ventyxbio.com

ventyxbio.com/pipeline/

Pipeline

A peripheral NLRP3 inhibitor such as VTX2735 may be an effective therapy for the treatment and prevention of recurrent pericarditis, offering a safe, oral ...

7.

ctv.veeva.com

ctv.veeva.com/study/an-open-label-pilot-study-of-vtx2735-in-recurrent-pericarditis

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP).