An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

Launched by ZOMAGEN BIOSCIENCES LTD. · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called VTX2735 to see if it is safe and effective for people with recurrent pericarditis, which is a condition that causes chest pain and inflammation around the heart. The trial will involve about 30 participants aged 18 to 75 who have had at least one episode of pericarditis and are currently experiencing symptoms. To be eligible, participants must be able to provide consent and have a certain level of pain and inflammation.

During the study, participants will go through several phases: first, a 30-day screening period to see if they qualify, followed by a 6-week treatment phase where they will receive VTX2735, and then a 7-week extension for those who continue to meet the criteria. After treatment, there will be a 14-day follow-up period. This study is currently recruiting participants, and it is important for potential candidates to discuss with their healthcare provider to determine if they meet the eligibility criteria and if this trial is a good option for them.

Gender

ALL

Eligibility 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 ≤ 1 mg/dL 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.