An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

May 20, 2026 updated by: Zomagen Biosciences Ltd.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Recruiting
        • Local Site #840101
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85718
        • Withdrawn
        • Local Site #840012
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • Local Site #840014
    • Florida
      • Saint Augustine, Florida, United States, 32086
        • Recruiting
        • Local Site #840016
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Local Site #840008
      • Park Ridge, Illinois, United States, 60068
        • Withdrawn
        • Local Site #840002
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Withdrawn
        • Local Site #840011
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Local Site #840010
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Local Site #840005
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Local Site #840020
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Local Site #840017
    • Texas
      • Houston, Texas, United States, 77034
        • Recruiting
        • Local Site #840001
      • Houston, Texas, United States, 77030
        • Recruiting
        • Local Site #840019
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • Local Site #840013
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • Local Site #840022
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • Local Site #840018
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Local Site #840004
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Local Site #840021

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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 ≤ 10 mg/L 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort A
Drug: VTX2735
Dose B, Daily
Drug: VTX2735
Dose A, Daily
Drug: VTX2735
Dose C, Daily
Drug: VTX2735
Dose D, Daily
Drug: VTX2735
Dose E, Daily
Experimental: Cohort B Treatment Group B1
Drug: VTX2735
Dose B, Daily
Drug: VTX2735
Dose A, Daily
Drug: VTX2735
Dose C, Daily
Drug: VTX2735
Dose D, Daily
Drug: VTX2735
Dose E, Daily
Experimental: Cohort B Treatment Group B2
Drug: VTX2735
Dose B, Daily
Drug: VTX2735
Dose A, Daily
Drug: VTX2735
Dose C, Daily
Drug: VTX2735
Dose D, Daily
Drug: VTX2735
Dose E, Daily
Experimental: Cohort C Treatment Group C1
Drug: VTX2735
Dose B, Daily
Drug: VTX2735
Dose A, Daily
Drug: VTX2735
Dose C, Daily
Drug: VTX2735
Dose D, Daily
Drug: VTX2735
Dose E, Daily
Experimental: Cohort C Treatment Group C2
Drug: VTX2735
Dose B, Daily
Drug: VTX2735
Dose A, Daily
Drug: VTX2735
Dose C, Daily
Drug: VTX2735
Dose D, Daily
Drug: VTX2735
Dose E, Daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability of VTX2735
Time Frame: Day 1 of treatment period through study completion, up to 26 weeks
Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation
Day 1 of treatment period through study completion, up to 26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect of VTX2735 on pericardial pain
Time Frame: Day 1 of treatment period to Week 6 of treatment period
Change from baseline in Numeric Pain Rating Scale (NRS) over time through Week 6
Day 1 of treatment period to Week 6 of treatment period
Effect of VTX2735 on inflammation
Time Frame: Day 1 of treatment period to Week 6 of treatment period
Change from baseline in High-Sensitivity C-Reactive Protein (hs-CRP) over time through Week 6
Day 1 of treatment period to Week 6 of treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zomagen Biosciences Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Beatriz Lindstrom, PhD, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VTX2735-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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