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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (16 locations)

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