An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

NCT ID: NCT06836232

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-28

Study Completion Date

2026-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Recurrent Pericarditis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A

Group Type EXPERIMENTAL

VTX2735

Intervention Type DRUG

Dose A, daily

VTX2735

Intervention Type DRUG

Dose B, Daily

Cohort B Treatment Group B1

Group Type EXPERIMENTAL

VTX2735

Intervention Type DRUG

Dose B, Daily

Cohort B Treatment Group B2

Group Type EXPERIMENTAL

VTX2735

Intervention Type DRUG

Dose C, daily

Interventions

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VTX2735

Dose A, daily

Intervention Type DRUG

VTX2735

Dose B, Daily

Intervention Type DRUG

VTX2735

Dose C, daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zomagen Biosciences Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henrik Sonnergren, MD, PhD

Role: STUDY_DIRECTOR

Ventyx Biosciences

Locations

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Local Site #840012

Tucson, Arizona, United States

Site Status RECRUITING

Local Site #840014

Orange, California, United States

Site Status RECRUITING

Local Site #840016

Saint Augustine, Florida, United States

Site Status RECRUITING

Local Site #840008

Chicago, Illinois, United States

Site Status RECRUITING

Local Site #840002

Park Ridge, Illinois, United States

Site Status RECRUITING

Local Site #840011

Owensboro, Kentucky, United States

Site Status WITHDRAWN

Local Site #840010

Boston, Massachusetts, United States

Site Status RECRUITING

Local Site #840005

Rochester, Minnesota, United States

Site Status RECRUITING

Local Site #840020

New York, New York, United States

Site Status RECRUITING

Local Site #840017

Cleveland, Ohio, United States

Site Status RECRUITING

Local Site #840019

Houston, Texas, United States

Site Status RECRUITING

Local Site #840001

Houston, Texas, United States

Site Status RECRUITING

Local Site #840013

Salt Lake City, Utah, United States

Site Status RECRUITING

Local Site #840018

Charlottesville, Virginia, United States

Site Status RECRUITING

Local Site #840004

Richmond, Virginia, United States

Site Status RECRUITING

Local Site #840021

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ventyx Clinical Trial Contact

Role: CONTACT

888-411-5176 ext. ext 108

Other Identifiers

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VTX2735-202

Identifier Type: -

Identifier Source: org_study_id

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