Recruiting
Phase 2

VTX2735

Sponsor:

Zomagen Biosciences Ltd.

Code:

NCT06836232

Conditions

Recurrent Pericarditis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

VTX2735

VTX2735

VTX2735

VTX2735

VTX2735

Study Details

Brief summary:

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

Conditions

Recurrent Pericarditis

Study ID

NCT06836232

Start date

Jan 28, 2025

Status verified date

May, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A

experimental: Cohort B Treatment Group B1

experimental: Cohort B Treatment Group B2

experimental: Cohort C Treatment Group C1

experimental: Cohort C Treatment Group C2

Interventions

VTX2735

Dose A, Daily

VTX2735

Dose B, Daily

VTX2735

Dose C, Daily

VTX2735

Dose D, Daily

VTX2735

Dose E, Daily

Primary outcome measure

  • Safety and tolerability of VTX2735 [ Time Frame: Day 1 of treatment period through study completion, up to 26 weeks ]

Central Contacts and Locations

Central contacts

Ventyx Clinical Trial Contact

888-411-5176ClinicalTrials@ventyxbio.com

Locations

Local Site #840014

Recruiting

Orange, California, United States, 92868

Local Site #840016

Recruiting

Saint Augustine, Florida, United States, 32086

Local Site #840008

Recruiting

Chicago, Illinois, United States, 60611

Local Site #840010

Recruiting

Boston, Massachusetts, United States, 02114

Local Site #840005

Recruiting

Rochester, Minnesota, United States, 55905

Local Site #840020

Recruiting

New York, New York, United States, 10032

Local Site #840017

Recruiting

Cleveland, Ohio, United States, 44195

Local Site #840019

Recruiting

Houston, Texas, United States, 77030

Local Site #840001

Recruiting

Houston, Texas, United States, 77034

Local Site #840013

Recruiting

Salt Lake City, Utah, United States, 84132

Local Site #840022

Recruiting

Burlington, Vermont, United States, 05401

Local Site #840018

Recruiting

Charlottesville, Virginia, United States, 22908

Local Site #840004

Recruiting

Richmond, Virginia, United States, 23219

Local Site #840021

Recruiting

Seattle, Washington, United States, 98105

Local Site #840101

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

More Information

Sponsor

Zomagen Biosciences Ltd.

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Zomagen Biosciences Ltd. on 2026-05-22.