An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

Last updated: April 30, 2025
Sponsor: Zomagen Biosciences Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Heart Disease

Cardiac Disease

Chest Pain

Treatment

VTX2735

Clinical Study ID

NCT06836232
VTX2735-202
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 foran acute pericarditis event

  • Ongoing symptomatic episode of pericarditis, or may have an episode of recurrentpericarditis 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 RPand 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 thesetreatments)

Exclusion

Exclusion Criteria:

  • Current or prior diagnosis of pericarditis that is secondary to specific prohibitedcauses, 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 ordata quality, per the Investigator's judgment.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: VTX2735
Phase: 2
Study Start date:
January 28, 2025
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Local Site #840012

    Tucson, Arizona 85718
    United States

    Active - Recruiting

  • Local Site #840016

    St. Augustine, Florida 32086
    United States

    Active - Recruiting

  • Local Site #840008

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Local Site #840002

    Park Ridge, Illinois 60068
    United States

    Active - Recruiting

  • Local Site #840011

    Owensboro, Kentucky 42303
    United States

    Active - Recruiting

  • Local Site #840001

    Houston, Texas 77034
    United States

    Active - Recruiting

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