An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

Recruiting now · Phase 2

Conditions studied: Recurrent Pericarditis

In brief

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

Key facts

Study ID: NCT06836232
Run by: Zomagen Biosciences Ltd.
People needed: 50
Starts: 2025-01-28
Expected to finish: 2027-10-01
Last updated by the study team: 2026-05-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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.

Where it is running

Local Site #840101 — Ottawa, Ontario, Canada (enrolling)
Local Site #840014 — Orange, California, United States (enrolling)
Local Site #840016 — Saint Augustine, Florida, United States (enrolling)
Local Site #840008 — Chicago, Illinois, United States (enrolling)
Local Site #840018 — Charlottesville, Virginia, United States (enrolling)
Local Site #840004 — Richmond, Virginia, United States (enrolling)
Local Site #840021 — Seattle, Washington, United States (enrolling)
Local Site #840010 — Boston, Massachusetts, United States (enrolling)
Local Site #840005 — Rochester, Minnesota, United States (enrolling)
Local Site #840020 — New York, New York, United States (enrolling)
Local Site #840017 — Cleveland, Ohio, United States (enrolling)
Local Site #840019 — Houston, Texas, United States (enrolling)
Local Site #840001 — Houston, Texas, United States (enrolling)
Local Site #840013 — Salt Lake City, Utah, United States (enrolling)
Local Site #840022 — Burlington, Vermont, United States (enrolling)
Local Site #840002 — Park Ridge, Illinois, United States
Local Site #840011 — Owensboro, Kentucky, United States
Local Site #840012 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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