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An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis | Clinical Trials | Clareo Health

RECRUITINGPHASE2

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

A Phase 2a, Open-Label Pilot Study to Evaluate the Safety/Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of VTX2735 in Participants With Recurrent Pericarditis

NCT06836232•Zomagen Biosciences Ltd.

View on ClinicalTrials.gov

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 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 up to 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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (16)

Local Site #840012

Tucson, Arizona, 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 #840002

Park Ridge, Illinois, United States

Local Site #840011

Owensboro, Kentucky, 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

Key Dates

Start Date

January 28, 2025

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2026

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Recurrent Pericarditis

Interventions

VTX2735

DRUG

VTX2735

DRUG

VTX2735

DRUG

Contacts

Ventyx Clinical Trial Contact

CONTACT

888-411-5176 ClinicalTrials@ventyxbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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