NCT06836232

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
13mo left

Started Jan 2025

Geographic Reach
3 countries

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Jan 2025Oct 2027

Study Start

First participant enrolled

January 28, 2025

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

2.7 years

First QC Date

February 14, 2025

Last Update Submit

September 21, 2026

Conditions

Recurrent Pericarditis

Keywords

VentyxZomagenRecurrent PericarditisVTX2735NLRP3 InhibitorNLRP3Inflammasome

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of VTX2735

    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 Outcomes (2)

  • Effect of VTX2735 on pericardial pain

    Day 1 of treatment period to Week 6 of treatment period

  • Effect of VTX2735 on inflammation

    Day 1 of treatment period to Week 6 of treatment period

Study Arms (5)

Cohort A

EXPERIMENTAL
Drug: VTX2735

Cohort B Treatment Group B1

EXPERIMENTAL
Drug: VTX2735

Cohort B Treatment Group B2

EXPERIMENTAL
Drug: VTX2735

Cohort C Treatment Group C1

EXPERIMENTAL
Drug: VTX2735

Cohort C Treatment Group C2

EXPERIMENTAL
Drug: VTX2735

Interventions

VTX2735DRUG

Dose A, Daily

Also known as: LY5625574
Cohort A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

UC San Diego Health

La Jolla, California, 92037, United States

NOT YET RECRUITING

University of California Irvine Medical Center

Orange, California, 92868, United States

RECRUITING

Flourish Research - St. Augustine - PPDS

Saint Augustine, Florida, 32086, United States

RECRUITING

Bluhm Cardiovascular Institute of Northwestern

Chicago, Illinois, 60611, United States

RECRUITING

MGH Heart Failure and Cardiac Transplant Center Corrigan Minehan Heart Center

Boston, Massachusetts, 02114, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905-0002, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Orion Medical

Houston, Texas, 77034, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

NOT YET RECRUITING

University of Virginia Health System Advanced Heart Failure and Transplant Center

Richmond, Virginia, 23298, United States

RECRUITING

VCU North Hospital

Richmond, Virginia, 23298, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

University Hospital Ghent

Ghent, 9000, Belgium

NOT YET RECRUITING

University Hospitals Leuven, Campus Gasthuisberg

Leuven, 3000, Belgium

NOT YET RECRUITING

McGill University Health Centre

Montreal, H4A 3J1, Canada

NOT YET RECRUITING

University of Ottawa Heart Institute

Ottawa, K1Y 4S7, Canada

RECRUITING

MeSH Terms

Conditions

Pericarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Ventyx Clinical Trial Contact

CONTACT

888-411-5176ClinicalTrials@ventyxbio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 20, 2025

Study Start

January 28, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(15)CA(2)BE(2)