An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

Phase 2

Recruiting

• Conditions: Recurrent Pericarditis
• Interventions: Drug: VTX2735

• Registration Number: NCT06836232
• Lead Sponsor: Zomagen Biosciences Ltd.

Brief Summary

This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP). Approximately 30 patients will take VTX2735.

The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 6-week Open Label Treatment period (a participant receives active Dose A), a 7-week Extension Treatment period (a participant meets criteria for continuing and receives active Dose A) and a 14-day Follow-Up Period.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-28
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-14
• Study First Posted: 2025-02-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VTX2735	VTX2735	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of VTX2735	Day 1 of treatment period through study completion, up to 15 weeks	Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation

Secondary Outcome Measures

Name	Time	Method
Effect of VTX2735 on pericardial pain	Day 1 of treatment period to Week 6 of treatment period	Change from baseline in Numeric Pain Rating Scale (NRS) over time through Week 6
Effect of VTX2735 on inflammation	Day 1 of treatment period to Week 6 of treatment period	Change from baseline in High-Sensitivity C-Reactive Protein (hs-CRP) over time through Week 6

Trial Locations

Locations (6)

Local Site #840012; 🇺🇸 Tucson, Arizona, United States

Local Site #840016; 🇺🇸 St. Augustine, Florida, United States

Local Site #840008; 🇺🇸 Chicago, Illinois, United States

Local Site #840002; 🇺🇸 Park Ridge, Illinois, United States

Local Site #840011; 🇺🇸 Owensboro, Kentucky, United States

Local Site #840001; 🇺🇸 Houston, Texas, United States