Skip to main content
Back to Trials
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

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Recurrent Pericarditis

Locations

UC San Diego Health

La Jolla, California 92037

United States

University of California Irvine Medical Center

Orange, California 92868

United States

Flourish Research - St. Augustine - PPDS

Saint Augustine, Florida 32086

United States

Bluhm Cardiovascular Institute of Northwestern

Chicago, Illinois 60611

United States

MGH Heart Failure and Cardiac Transplant Center Corrigan Minehan Heart Center

Boston, Massachusetts 02114

United States

Mayo Clinic

Rochester, Minnesota 55905-0002

United States

Columbia University Irving Medical Center

New York, New York 10032

United States

The Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

Orion Medical

Houston, Texas 77034

United States

University of Utah

Salt Lake City, Utah 84132

United States

University of Vermont Medical Center

Burlington, Vermont 05401

United States

University of Virginia Health System Advanced Heart Failure and Transplant Center

Richmond, Virginia 23298

United States

VCU North Hospital

Richmond, Virginia 23298

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

University Hospital Ghent

Ghent, 9000

Belgium

University Hospitals Leuven, Campus Gasthuisberg

Leuven, 3000

Belgium

McGill University Health Centre

Montreal, H4A 3J1

Canada

University of Ottawa Heart Institute

Ottawa, K1Y 4S7

Canada

General Hospital of Athens "Ippokratio"

Athens, 11527

Greece