An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

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.

Conditions

Recurrent Pericarditis

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Study Overview

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Study Details

Study overview

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.

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

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

Condition
Recurrent Pericarditis
Intervention / Treatment

-

Contacts and Locations

Park Ridge

Local Site #840002, Park Ridge, Illinois, United States, 60068

Houston

Local Site #840001, Houston, Texas, United States, 77034

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zomagen Biosciences Ltd.,

Henrik Sonnergren, MD, PhD, STUDY_DIRECTOR, Ventyx Biosciences

Study Record Dates

2026-01