Testing VTX2735 for treating recurrent pericarditis
A Phase 2a, Open-Label Pilot Study to Evaluate the Safety/Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of VTX2735 in Participants With Recurrent Pericarditis
This study is testing a new drug called VTX2735 to see if it can help people with recurrent pericarditis feel better and reduce their symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zomagen Biosciences Ltd. Industry-sponsored |
| Locations | 17 sites (Tucson, Arizona and 16 other locations) |
| Trial ID | NCT06836232 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of VTX2735 in patients diagnosed with recurrent pericarditis. Approximately 30 participants will undergo a 30-day screening period followed by a 6-week open-label treatment phase where they will receive the active drug. If they meet specific criteria, they may continue treatment for an additional 7 weeks, followed by a 14-day follow-up period. The study aims to assess the impact of VTX2735 on symptoms and inflammation associated with recurrent pericarditis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a history of recurrent pericarditis and ongoing symptoms.
Not a fit: Patients with pericarditis caused by specific conditions such as tuberculosis or autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate symptoms and improve the quality of life for patients suffering from recurrent pericarditis.
How similar studies have performed: While this approach is novel, previous studies on NLRP3 inhibitors have shown promise in related inflammatory conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants are male or female ≥ 18 years up to ≤ 75 years of age. * Capable of giving signed informed consent and able to comply with the protocol * Previously had an index (first) episode of pericarditis which met the criteria for an acute pericarditis event * Ongoing symptomatic episode of pericarditis, or may have an episode of recurrent pericarditis in the next 4 weeks. * CRP by local laboratory assessment prior to first dose of study treatment (participants with CRP ≤ 10 mg/L must be receiving corticosteroid treatment for RP and have evidence of pericardial inflammation) * Pericarditis pain score ≥ 4 based on the 11-point NRS. * Stable doses of NSAIDs, colchicine, and/or oral corticosteroids (if receiving these treatments) Exclusion Criteria: * Current or prior diagnosis of pericarditis that is secondary to specific prohibited causes, including but not limited to tuberculosis, blunt trauma, tumor, myocarditis, or systemic autoimmune diseases. * History of clinically significant immunosuppressive disorder, autoimmune/autoinflammatory disorder, or primary or secondary immunodeficiency. * Clinically important history of a medical disorder that would compromise safety or data quality, per the Investigator's judgment.
Where this trial is running
Tucson, Arizona and 16 other locations
- Local Site #840012 — Tucson, Arizona, United States (Withdrawn)
- Local Site #840014 — Orange, California, United States (Recruiting)
- Local Site #840016 — Saint Augustine, Florida, United States (Recruiting)
- Local Site #840008 — Chicago, Illinois, United States (Recruiting)
- Local Site #840002 — Park Ridge, Illinois, United States (Withdrawn)
- Local Site #840011 — Owensboro, Kentucky, United States (Withdrawn)
- Local Site #840010 — Boston, Massachusetts, United States (Recruiting)
- Local Site #840005 — Rochester, Minnesota, United States (Recruiting)
- Local Site #840020 — New York, New York, United States (Recruiting)
- Local Site #840017 — Cleveland, Ohio, United States (Recruiting)
- Local Site #840019 — Houston, Texas, United States (Recruiting)
- Local Site #840001 — Houston, Texas, United States (Recruiting)
- Local Site #840013 — Salt Lake City, Utah, United States (Recruiting)
- Local Site #840018 — Charlottesville, Virginia, United States (Recruiting)
- Local Site #840004 — Richmond, Virginia, United States (Recruiting)
- Local Site #840021 — Seattle, Washington, United States (Recruiting)
- Local Site #840101 — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Ventyx Clinical Trial Contact
- Email: ClinicalTrials@ventyxbio.com
- Phone: 888-411-5176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.