RECRUITING

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

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). Cohort A will include up to 30 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 up to 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

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:2026-10
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 CriteriaExclusion Criteria
  1. * Participants are male or female ≥ 18 years up to ≤ 75 years of age.
  2. * Capable of giving signed informed consent and able to comply with the protocol
  3. * Previously had an index (first) episode of pericarditis which met the criteria for an acute pericarditis event
  4. * Ongoing symptomatic episode of pericarditis, or may have an episode of recurrent pericarditis in the next 4 weeks.
  5. * 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)
  6. * Pericarditis pain score ≥ 4 based on the 11-point NRS.
  7. * Stable doses of NSAIDs, colchicine, and/or oral corticosteroids (if receiving these treatments)
  1. * 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.
  2. * History of clinically significant immunosuppressive disorder, autoimmune/autoinflammatory disorder, or primary or secondary immunodeficiency.
  3. * 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 #840012
Tucson, Arizona, 85718
United States
Local Site #840014
Orange, California, 92868
United States
Local Site #840016
Saint Augustine, Florida, 32086
United States
Local Site #840008
Chicago, Illinois, 60611
United States
Local Site #840002
Park Ridge, Illinois, 60068
United States
Local Site #840011
Owensboro, Kentucky, 42303
United States
Local Site #840010
Boston, Massachusetts, 02114
United States
Local Site #840005
Rochester, Minnesota, 55905
United States
Local Site #840017
Cleveland, Ohio, 44195
United States
Local Site #840019
Houston, Texas, 77030
United States
Local Site #840001
Houston, Texas, 77034
United States
Local Site #840013
Salt Lake City, Utah, 84132
United States
Local Site #840018
Charlottesville, Virginia, 22908
United States
Local Site #840004
Richmond, Virginia, 23219
United States
Local Site #840021
Seattle, Washington, 98105
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 Date2026-10

Study Record Updates

Study Start Date2025-01-28
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Ventyx
  • Zomagen
  • Recurrent Pericarditis
  • VTX2735
  • NLRP3 Inhibitor
  • NLRP3
  • Inflammasome

Additional Relevant MeSH Terms

  • Recurrent Pericarditis