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RECRUITING
NCT06836232
PHASE2

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

Sponsor: 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 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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-01-28

Completion Date

2027-10

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

DRUG

VTX2735

Dose A, Daily

DRUG

VTX2735

Dose B, Daily

DRUG

VTX2735

Dose C, Daily

DRUG

VTX2735

Dose D, Daily

DRUG

VTX2735

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