An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

April 29, 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • 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 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        • Withdrawn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
    • 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

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
Intervention / Treatment
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

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

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

Zomagen Biosciences Ltd.

Investigators

  • 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)

January 28, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

February 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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