VTX2735 for Pericarditis

Recruiting at 7 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

30 Participants Needed

Trial Summary

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.

How does the drug VTX2735 differ from other treatments for pericarditis?

The treatment of pericarditis typically involves non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine, with corticosteroids used in specific cases. VTX2735 may offer a novel approach, but specific details about its mechanism or benefits compared to existing treatments are not provided in the available research. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP). Approximately 30 patients will take VTX2735. The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 6-week Open Label Treatment period (a participant receives active Dose A), a 7-week Extension Treatment period (a participant meets criteria for continuing and receives active Dose A) and a 14-day Follow-Up Period.

Research Team

Henrik Sonnergren, MD, PhD

Principal Investigator

Ventyx Biosciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: VTX2735 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Zomagen Biosciences Ltd.

Lead Sponsor

Trials

4

Recruited

210+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Individualized therapy for pericarditis. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Frequency and predictors of urgent coronary angiography in patients with acute pericarditis. [2023]

3. Brazil pubmed.ncbi.nlm.nih.gov

Pericarditis. Series of 84 consecutive cases. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[New possibilities of diagnostics and therapy of pericarditis]. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The differential diagnosis of acute pericarditis from the normal variant: new electrocardiographic criteria. [2023]