Phase 2a Open-Label Pilot Study to Test Safety and Effectiveness of VTX2735 for Recurrent Pericarditis in Adults Aged 18 to 75

What this Trial Is About

Researchers are studying VTX2735 to understand its safety and effectiveness in people diagnosed with Recurrent Pericarditis. This Phase 2a open-label pilot study aims to evaluate how well participants tolerate the drug and how it affects pain and inflammation related to their condition. Participants will be adults aged 18 to 75 years who have experienced an episode of pericarditis and currently have symptoms or a risk of recurrence within the next four weeks. The study includes three groups Cohorts A, B, and C with different dosing schedules of VTX2735. Each cohort begins with a 30-day screening period to assess eligibility. Cohort A participants receive Dose A daily for 6 weeks, with possible extensions including the same dose or Dose B for up to 7 weeks and 11 weeks respectively, followed by a 14-day follow-up. Cohorts B and C also receive daily doses of VTX2735 various doses B, C, D, or E during a 6-week treatment period, with possible 18-week extension periods and a 14-day follow-up. Participants will have their symptoms, such as pericardial pain and inflammation, monitored regularly during treatment. Safety and tolerability of VTX2735 are tracked from the first day of treatment through study completion, up to 26 weeks. The study involves assessments like pain scoring and blood tests for inflammation markers. Overall, participants can expect regular visits for treatment, monitoring, and follow-up over several months as researchers gather information on the drugs effects and safety.

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis