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RECRUITING Phase 2 ClinicalTrials.gov

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

Sponsor: Zomagen Biosciences Ltd. • ClinicalTrials.gov ID: NCT06836232

Registry updated: 2026-10-09
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Description

This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP). Cohort A will include approximately 10 participants and will consist of the following: * A 30-day Screening Period (to see if a participant qualifies for the study) * A 6-week Open Label Treatment Period - participant receives VTX2735 Dose A * A 7-week Extension Treatment Period (if a participant meets criteria for extension treatment) - participant receives VTX2735 Dose A * An 11-week Once Daily Treatment Period (if a participant meets criteria for this treatment period) - participant receives VTX2735 Dose B * A 14-day Follow-Up Period Cohort B will include approximately 20 participants and will consist of the following: * A 30-day Screening Period (to see if a participant qualifies for the study) * A 6-week Open Label Treatment Period - participant receives VTX2735 Dose B or C * An 18-week Extension Treatment Period (if a participant meets criteria for extension treatment) - participant receives VTX2735 Dose B or C * A 14-day Follow-Up Period Cohort C will include approximately 20 participants and will consist of the following: * A 30-day Screening Period (to see if a participant qualifies for the study) * A 6-week Open Label Treatment Period - participant receives VTX2735 Dose D or E, and B * An 18-week Extension Treatment Period (if a participant meets criteria for extension treatment) - participant receives VTX2735 Dose B * A 14-day Follow-Up Period

Interventions

  • VTX2735 (Drug)
    Dose A, Daily
  • VTX2735 (Drug)
    Dose B, Daily
  • VTX2735 (Drug)
    Dose C, Daily
  • VTX2735 (Drug)
    Dose D, Daily
  • VTX2735 (Drug)
    Dose E, Daily

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.

Conditions

Recurrent Pericarditis

Locations

  • Site Location #840023 — La Jolla, California, United States
  • Local Site #840014 — Orange, California, United States
  • Local Site #840016 — Saint Augustine, Florida, United States
  • Local Site #840008 — Chicago, Illinois, United States
  • Local Site #840010 — Boston, Massachusetts, United States
  • Local Site #840005 — Rochester, Minnesota, United States
  • Local Site #840020 — New York, New York, United States
  • Local Site #840017 — Cleveland, Ohio, United States
  • Local Site #840019 — Houston, Texas, United States
  • Local Site #840001 — Houston, Texas, United States
  • Local Site #840013 — Salt Lake City, Utah, United States
  • Local Site #840022 — Burlington, Vermont, United States
  • Local Site #840004 — Richmond, Virginia, United States
  • Local Site #840018 — Richmond, Virginia, United States
  • Local Site #840021 — Seattle, Washington, United States
  • Local Site #056001 — Ghent, Belgium
  • Local Site #056002 — Leuven, Belgium
  • Local Site #840102 — Montreal, Canada
  • Local Site #840101 — Ottawa, Canada
  • Local Site #300001 — Athens, Greece
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record