Table of Contents
- Trial overview
- Study design and phase
- Who can participate
- What is being measured
- Trial status and size
Trial overview
The available study is a phase 2 open-label pilot study of VTX2735 SODIUM in people with recurrent pericarditis.[1] The trial brief says it is being done to evaluate the safety and tolerability of VTX2735 SODIUM in participants with recurrent pericarditis.[1]
Study design and phase
This is an interventional study, which means the researchers give a planned treatment and then observe what happens.[1] It is also described as open-label, so the study treatment is not hidden from participants or researchers.[1] The study is in phase 2, a stage that usually looks at safety and early signals in a specific patient group.[1]
Who can participate
The trial is for participants with recurrent pericarditis.[1] The source data do not give more detailed entry rules, so other eligibility requirements are not listed here.[1]
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.[1] These events are tracked from the first dose through the end of the follow-up period.[1] In simple terms, the study is checking how often unwanted medical problems happen, how serious they are, and whether they make people stop treatment.[1]
Trial status and size
The study status is Authorised.[1] The planned enrollment is 31 participants, which makes this a small pilot study.[1] 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.[1]
