VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA)

December 23, 2024 updated by: Ventyx Biosciences, Inc

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Patients With Active Psoriatic Arthritis

The objective of this study is to evaluate if VTX958 is safe and effective in adult participants with active Psoriatic Arthritis. Approximately 195 eligible participants will take VTX958 Dose A, VTX958 Dose B, or matching placebo (no active drug) for 16 weeks and then move on to a 36 week Long Term Extension (LTE). The study will include 16 weeks of treatment, 36 weeks of LTE, and a 30-day follow-up period.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two doses of VTX958 tablets, Dose A and Dose B, in adults with active Psoriatic Arthritis. Approximately 195 participants will be assigned in a 1:1:1 ratio to one of three groups, VTX958 Dose A, VTX958 Dose B, or placebo, for 16 weeks and then move on to a 36 week Long Term Extension (LTE). The study consists of a 30-day screening period, a 16 week double-blind treatment period, 36 weeks of LTE, and a 30 day follow-up period.

Study Type

Interventional

Enrollment (Actual)

205

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 Locations

  • Bulgaria
      • Haskovo, Bulgaria, 6300
        • Site # 100004
      • Plovdiv, Bulgaria, 4003
        • Site # 100001
      • Plovdiv, Bulgaria, 4004
        • Site # 100002
  • Czechia
      • Hlučín, Czechia, 748 01
        • Site # 203004
      • Ostrava, Czechia, 702 00
        • Site # 203001
      • Pardubice, Czechia, 530 02
        • Site # 203003
      • Praha 5, Czechia, 150 00
        • Site # 203005
      • Zlín, Czechia, 760 01
        • Site # 203002
  • Germany
      • Berlin, Germany, 12161
        • Site # 276002
      • Hamburg, Germany, 20095
        • Site # 276001
  • Hungary
      • Budapest, Hungary, 1036
        • Site # 348003
      • Hódmezővásárhely, Hungary, 6800
        • Site # 348001
      • Kistarcsa, Hungary, 2143
        • Site # 348004
  • Poland
      • Gdynia, Poland, 81-338
        • Site # 616015
      • Katowice, Poland, 40-081
        • Site # 616007
      • Kraków, Poland, 30-727
        • Site # 616010
      • Lublin, Poland, 20-582
        • Site # 616013
      • Nadarzyn, Poland, 05-830
        • Site # 616002
      • Olsztyn, Poland, 10-117
        • Site # 616011
      • Poznań, Poland, 61-113
        • Site # 616004
      • Toruń, Poland, 87-100
        • Site # 616008
      • Warszawa, Poland, 00-874
        • Site # 616006
      • Warszawa, Poland, 03-291
        • Site #616001
      • Wrocław, Poland, 52-416
        • Site # 616003
      • Wrocław, Poland, 53-224
        • Site # 616016
      • Łódź, Poland, 90-265
        • Site # 616009
      • Łódź, Poland, 90-436
        • Site # 616012
      • Łódź, Poland, 91-495
        • Site # 616014
  • Spain
      • A Coruña, Spain, 15006
        • Site # 724002
      • Lleida, Spain, 25198
        • Site # 724005
      • Sevilla, Spain, 41009
        • Site # 724001
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Site # 840001
    • California
      • Newport Beach, California, United States, 92663
        • Site # 840016
    • Florida
      • Clearwater, Florida, United States, 33765
        • Site # 840004
      • Miami Lakes, Florida, United States, 33014
        • Site # 840014
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Site # 840017
    • Michigan
      • Okemos, Michigan, United States, 48864
        • Site # 840018
      • Saint Clair Shores, Michigan, United States, 48081
        • Site #840012
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • Site # 840019
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Site # 840003
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Site # 840007
    • Texas
      • Baytown, Texas, United States, 77521
        • Site # 840010
      • Lubbock, Texas, United States, 79410
        • Site # 840006
      • Mesquite, Texas, United States, 75150
        • Site # 840015
    • West Virginia
      • Beckley, West Virginia, United States, 25802
        • Site # 840011
      • South Charleston, West Virginia, United States, 25309
        • Site # 840008

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with Psoriatic Arthritis for 6 months or more prior to Screening
  • Documented history or active signs of at least 1 confirmed lesion of plaque psoriasis and/or nail changes attributed to psoriasis
  • Active PsA as defined by 3 or more swollen joints and 3 or more tender joints at Screening and Day 1
  • Women must not be of childbearing potential or must agree to use a highly effective contraception during the study and for 30 days after the last dose of the study product
  • Men with a partner who is of childbearing potential must agree to use condoms during the study and for 90 days after the last dose of study product

Exclusion Criteria:

  • Has non-plaque psoriasis at Screening or Day 1
  • Has inflammatory bowel disease or active uveitis
  • Has a history of chronic or recurrent infectious disease
  • Has a known immune deficiency or is immunocompromised
  • Has hepatitis B or hepatitis C infection, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or active tuberculosis (TB) at screening

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: VTX958 Dose A
Drug: Dose A VTX958
Dose A VTX958
Experimental: VTX958 Dose B
Drug: Dose B VTX958
Dose B VTX958

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 16
Time Frame: Week 16
Number of participants reaching ACR20 at week 16, compared to the total number of participants in each cohort
Week 16
Incidence of Treatment Emergent Adverse Events (TEAEs) from week 0 through week 16
Time Frame: Week 16
The number and proportion of participants who have at least 1 TEAE after exposure to the study drug
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) scores at Week 16
Time Frame: Week 16
HAQ-DI assesses functional ability. It is a 20 question instrument that assesses the degree of difficulty with accomplishing tasks in 8 functional areas (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty) to 3 (inability to perform a task in that area). The overall HAQ-DI score is the mean of the 8 functional area scores and ranges from 0 to 3. Lower scores are indicative of improved functional ability.
Week 16
Proportion of participants achieving 75% reduction in the Psoriasis Area and Severity Index (PASI75) score at Week 16, in participants with at least 3% body surface area (BSA) involvement at baseline
Time Frame: Week 16
PASI is used to assess the severity of psoriasis and response to therapy. Each body region is evaluated separately for body surface area percentage of involvement and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement) and for erythema, induration, and scaling, each is rated on scale of 0 to 4 (from none to maximum severity). PASI numeric scores range from 0 (no psoriasis) to 72 (maximal disease). Higher scores indicate more severe disease.
Week 16
Change from baseline in Short Form Health Survey - 36 items (SF-36) physical component score (PCS) at Week 16
Time Frame: Week 16
SF-36 is a 36-item, patient-reported measure of health status and quality of life, which includes 8 domains (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health). Each of the 8 domains contribute in different proportions to the physical component summary (PCS) score and the mental component summary (MCS) score, which are normalized to general US population norms and range from 0 to 100 (where higher scores correspond to a better quality of life).
Week 16
Proportion of participants achieving 50% improvement in American College of Rheumatology criteria (ACR50) at Week 16
Time Frame: Week 16
Number of participants reaching ACR50 at week 16, compared to the total number of participants in each cohort
Week 16
Proportion of participants achieving 70% improvement in American College of Rheumatology criteria (ACR70) at Week 16
Time Frame: Week 16
Number of participants reaching ACR70 at week 16, compared to the total number of participants in each cohort
Week 16

Collaborators and Investigators

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

Sponsor

Ventyx Biosciences, Inc

Investigators

  • Study Director: Matt Cascino, MD, Ventyx Biosciences, Inc

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 31, 2023

Primary Completion (Actual)

January 2, 2024

Study Completion (Actual)

January 2, 2024

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

February 4, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTX958-203

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.

Subscribe