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NCT06836232PHASE2Recruiting

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

Zomagen Biosciences Ltd.

Start Date

1/28/2025

Completion Date

10/1/2027

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 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

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

VTX2735

DRUG

VTX2735

DRUG

VTX2735

DRUG

VTX2735

DRUG

VTX2735

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Conditions

Recurrent Pericarditis

Locations

Local Site #840012

Tucson, Arizona 85718

United States

Local Site #840014

Orange, California 92868

United States

Local Site #840016

Saint Augustine, Florida 32086

United States

Local Site #840008

Chicago, Illinois 60611

United States

Local Site #840002

Park Ridge, Illinois 60068

United States

Local Site #840011

Owensboro, Kentucky 42303

United States

Local Site #840010

Boston, Massachusetts 02114

United States

Local Site #840005

Rochester, Minnesota 55905

United States

Local Site #840020

New York, New York 10032

United States

Local Site #840017

Cleveland, Ohio 44195

United States

Local Site #840019

Houston, Texas 77030

United States

Local Site #840001

Houston, Texas 77034

United States

Local Site #840013

Salt Lake City, Utah 84132

United States

Local Site #840022

Burlington, Vermont 05401

United States

Local Site #840018

Charlottesville, Virginia 22908

United States

Local Site #840004

Richmond, Virginia 23219

United States

Local Site #840021

Seattle, Washington 98105

United States

Local Site #840101

Ottawa, Ontario K1Y 4W7

Canada