RECRUITING

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

Conditions

Recurrent Pericarditis Ventyx Zomagen VTX2735 NLRP3 Inhibitor NLRP3 Inflammasome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP). Approximately 30 patients will take VTX2735. The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 6-week Open Label Treatment period (a participant receives active Dose A), a 7-week Extension Treatment period (a participant meets criteria for continuing and receives active Dose A) and 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

Quick Facts

Study Start:2025-01-28

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06836232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 ≤ 1 mg/dL 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)	* 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.

Inclusion Criteria

Exclusion 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 ≤ 1 mg/dL 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)

* 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.

Contacts and Locations

Study Contact

Ventyx Clinical Trial Contact

CONTACT

888-411-5176

ClinicalTrials@ventyxbio.com

Principal Investigator

Henrik Sonnergren, MD, PhD

STUDY_DIRECTOR

Ventyx Biosciences

Study Locations (Sites)

Local Site #840002

Park Ridge, Illinois, 60068

United States

Local Site #840001

Houston, Texas, 77034

United States

Collaborators and Investigators

Sponsor: Zomagen Biosciences Ltd.

Henrik Sonnergren, MD, PhD, STUDY_DIRECTOR, Ventyx Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-28

Study Completion Date2026-01

Study Record Updates

Study Start Date2025-01-28

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

Ventyx
Zomagen
Recurrent Pericarditis
VTX2735
NLRP3 Inhibitor
NLRP3
Inflammasome

Additional Relevant MeSH Terms

Recurrent Pericarditis