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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
205

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ventyx Biosciences, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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