Status:
RECRUITING
An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis
Lead Sponsor:
Zomagen Biosciences Ltd.
Conditions:
Recurrent Pericarditis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP). Cohort A will include up to 30 participants and will consist of the f...
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 ≤ 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.
Key Trial Info
Start Date :
January 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06836232
Start Date
January 28 2025
End Date
October 1 2026
Last Update
February 17 2026
Active Locations (16)
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1
Local Site #840012
Tucson, Arizona, United States, 85718
2
Local Site #840014
Orange, California, United States, 92868
3
Local Site #840016
Saint Augustine, Florida, United States, 32086
4
Local Site #840008
Chicago, Illinois, United States, 60611