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(18)

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

Local Site #840019

Houston, Texas, United States

Local Site #840001

Houston, Texas, United States

Local Site #840013

Salt Lake City, Utah, United States

Local Site #840022

Burlington, Vermont, United States

Local Site #840018

Charlottesville, Virginia, United States

Local Site #840004

Richmond, Virginia, United States

Local Site #840021

Seattle, Washington, United States

Local Site #840101

Ottawa, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06836232


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