In short
Clinical trials are studying VTX2735 SODIUM in people with recurrent pericarditis, a condition where the lining around the heart becomes inflamed again and again. The trial is looking mainly at safety and tolerability in a phase 2 open-label study. It also helps define which patients may be able to take part.
Key points
- Clinical trials of VTX2735 SODIUM are focused on recurrent pericarditis. The available study is a phase 2 open-label pilot trial with 31 planned participants. Its main goal is to evaluate safety and tolerability. The primary outcome measures the number and severity of adverse events, serious adverse events, and treatment stops caused by side effects. This trial is authorised and studies people with recurrent pericarditis.
Trial overview
The available study is a phase 2 open-label pilot study of VTX2735 SODIUM in people with recurrent pericarditis. The trial brief says it is being done to evaluate the safety and tolerability of VTX2735 SODIUM in participants with recurrent pericarditis.
Study design and phase
This is an interventional study, which means the researchers give a planned treatment and then observe what happens. It is also described as open-label, so the study treatment is not hidden from participants or researchers. The study is in phase 2, a stage that usually looks at safety and early signals in a specific patient group.
Who can participate
The trial is for participants with recurrent pericarditis. The source data do not give more detailed entry rules, so other eligibility requirements are not listed here.
What is being measured
The main outcome is the incidence and severity of adverse events, serious adverse events, and adverse events that lead to study treatment discontinuation. These events are tracked from the first dose through the end of the follow-up period. In simple terms, the study is checking how often unwanted medical problems happen, how serious they are, and whether they make people stop treatment.
Trial status and size
The study status is Authorised. The planned enrollment is 31 participants, which makes this a small pilot study. The title also describes the study as a phase 2a open-label pilot study, which suggests it is an early step within phase 2 research.