RecruitingPhase 2NCT06836232

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


Sponsor

Zomagen Biosciences Ltd.

Enrollment

50 participants

Start Date

Jan 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called VTX2735, a drug called VTX2735, and others for people with recurrent pericarditis. The study is currently recruiting participants at 18 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVTX2735

Dose A, Daily

DRUGVTX2735

Dose B, Daily

DRUGVTX2735

Dose C, Daily

DRUGVTX2735

Dose D, Daily

DRUGVTX2735

Dose E, Daily


Locations(19)

UC San Diego Health

La Jolla, California, United States

University of California Irvine Medical Center

Orange, California, United States

Flourish Research - St. Augustine - PPDS

Saint Augustine, Florida, United States

Bluhm Cardiovascular Institute of Northwestern

Chicago, Illinois, United States

MGH Heart Failure and Cardiac Transplant Center Corrigan Minehan Heart Center

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Columbia University Irving Medical Center

New York, New York, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Houston Methodist Hospital

Houston, Texas, United States

Orion Medical

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Vermont Medical Center

Burlington, Vermont, United States

University of Virginia Health System Advanced Heart Failure and Transplant Center

Richmond, Virginia, United States

VCU North Hospital

Richmond, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

University Hospital Ghent

Ghent, Belgium

University Hospitals Leuven, Campus Gasthuisberg

Leuven, Belgium

McGill University Health Centre

Montreal, Canada

University of Ottawa Heart Institute

Ottawa, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06836232


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