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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05715125
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ventyx Biosciences, Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Matt Cascino, MD
Principal Investigator Affiliation Ventyx Biosciences, Inc
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Bulgaria, Czechia, Germany, Hungary, Poland, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis
Additional Details

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.

Arms & Interventions

Arms

Placebo Comparator: Placebo

Experimental: VTX958 Dose A

Experimental: VTX958 Dose B

Interventions

Drug: - Dose A VTX958

Dose A VTX958

Drug: - Dose B VTX958

Dose B VTX958

Drug: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Site # 840001, Phoenix, Arizona

Status

Recruiting

Address

Site # 840001

Phoenix, Arizona, 85032

Site # 840016, Newport Beach, California

Status

Recruiting

Address

Site # 840016

Newport Beach, California, 92663

Site # 840004, Clearwater, Florida

Status

Recruiting

Address

Site # 840004

Clearwater, Florida, 33765

Site # 840014, Miami Lakes, Florida

Status

Recruiting

Address

Site # 840014

Miami Lakes, Florida, 33014

Site # 840017, Lexington, Kentucky

Status

Recruiting

Address

Site # 840017

Lexington, Kentucky, 40504

Site # 840018, Okemos, Michigan

Status

Recruiting

Address

Site # 840018

Okemos, Michigan, 48864

Site #840012, Saint Clair Shores, Michigan

Status

Recruiting

Address

Site #840012

Saint Clair Shores, Michigan, 48081

Site # 840019, Eagan, Minnesota

Status

Recruiting

Address

Site # 840019

Eagan, Minnesota, 55121

Site # 840003, Middleburg Heights, Ohio

Status

Recruiting

Address

Site # 840003

Middleburg Heights, Ohio, 44130

Site # 840007, Duncansville, Pennsylvania

Status

Recruiting

Address

Site # 840007

Duncansville, Pennsylvania, 16635

Site # 840002, Jackson, Tennessee

Status

Withdrawn

Address

Site # 840002

Jackson, Tennessee, 38305

Site # 840010, Baytown, Texas

Status

Recruiting

Address

Site # 840010

Baytown, Texas, 77521

Site # 840006, Lubbock, Texas

Status

Recruiting

Address

Site # 840006

Lubbock, Texas, 79410

Site # 840015, Mesquite, Texas

Status

Recruiting

Address

Site # 840015

Mesquite, Texas, 75150

Site # 840011, Beckley, West Virginia

Status

Recruiting

Address

Site # 840011

Beckley, West Virginia, 25802

Site # 840008, South Charleston, West Virginia

Status

Recruiting

Address

Site # 840008

South Charleston, West Virginia, 25309

International Sites

Site # 100004, Haskovo, Bulgaria

Status

Recruiting

Address

Site # 100004

Haskovo, , 6300

Site # 100007, Pleven, Bulgaria

Status

Withdrawn

Address

Site # 100007

Pleven, , 5800

Site # 100001, Plovdiv, Bulgaria

Status

Recruiting

Address

Site # 100001

Plovdiv, , 4003

Site # 100002, Plovdiv, Bulgaria

Status

Recruiting

Address

Site # 100002

Plovdiv, , 4004

Site # 100005, Ruse, Bulgaria

Status

Withdrawn

Address

Site # 100005

Ruse, , 7002

Site # 100003, Sofia, Bulgaria

Status

Withdrawn

Address

Site # 100003

Sofia, , 1680

Site # 203004, Hlučín, Czechia

Status

Recruiting

Address

Site # 203004

Hlučín, , 748 01

Site # 203001, Ostrava, Czechia

Status

Recruiting

Address

Site # 203001

Ostrava, , 702 00

Site # 203003, Pardubice, Czechia

Status

Recruiting

Address

Site # 203003

Pardubice, , 530 02

Site # 203005, Praha 5, Czechia

Status

Recruiting

Address

Site # 203005

Praha 5, , 150 00

Site # 203002, Zlín, Czechia

Status

Recruiting

Address

Site # 203002

Zlín, , 760 01

Site # 276002, Berlin, Germany

Status

Recruiting

Address

Site # 276002

Berlin, , 12161

Site # 276001, Hamburg, Germany

Status

Recruiting

Address

Site # 276001

Hamburg, , 20095

Site # 348002, Budapest, Hungary

Status

Withdrawn

Address

Site # 348002

Budapest, , 1026

Site # 348003, Budapest, Hungary

Status

Recruiting

Address

Site # 348003

Budapest, , 1036

Site # 348001, Hódmezővásárhely, Hungary

Status

Recruiting

Address

Site # 348001

Hódmezővásárhely, , 6800

Site # 348004, Kistarcsa, Hungary

Status

Recruiting

Address

Site # 348004

Kistarcsa, , 2143

Site # 616015, Gdynia, Poland

Status

Recruiting

Address

Site # 616015

Gdynia, , 81-338

Site # 616007, Katowice, Poland

Status

Recruiting

Address

Site # 616007

Katowice, , 40-081

Site # 616010, Kraków, Poland

Status

Recruiting

Address

Site # 616010

Kraków, , 30-727

Site # 616013, Lublin, Poland

Status

Recruiting

Address

Site # 616013

Lublin, , 20-582

Site # 616002, Nadarzyn, Poland

Status

Recruiting

Address

Site # 616002

Nadarzyn, , 05-830

Site # 616011, Olsztyn, Poland

Status

Recruiting

Address

Site # 616011

Olsztyn, , 10-117

Site # 616004, Poznań, Poland

Status

Recruiting

Address

Site # 616004

Poznań, , 61-113

Site # 616008, Toruń, Poland

Status

Recruiting

Address

Site # 616008

Toruń, , 87-100

Site # 616006, Warszawa, Poland

Status

Recruiting

Address

Site # 616006

Warszawa, , 00-874

Site #616001, Warszawa, Poland

Status

Recruiting

Address

Site #616001

Warszawa, , 03-291

Site # 616003, Wrocław, Poland

Status

Recruiting

Address

Site # 616003

Wrocław, , 52-416

Site # 616016, Wrocław, Poland

Status

Recruiting

Address

Site # 616016

Wrocław, , 53-224

Site # 616009, Łódź, Poland

Status

Recruiting

Address

Site # 616009

Łódź, , 90-265

Site # 616012, Łódź, Poland

Status

Recruiting

Address

Site # 616012

Łódź, , 90-436

Site # 616014, Łódź, Poland

Status

Recruiting

Address

Site # 616014

Łódź, , 91-495

Site # 724002, A Coruña, Spain

Status

Recruiting

Address

Site # 724002

A Coruña, , 15006

Site # 724005, Lleida, Spain

Status

Recruiting

Address

Site # 724005

Lleida, , 25198

Site # 724004, Málaga, Spain

Status

Withdrawn

Address

Site # 724004

Málaga, , 29009

Site # 724003, Mérida, Spain

Status

Withdrawn

Address

Site # 724003

Mérida, , 6800

Site # 724001, Sevilla, Spain

Status

Recruiting

Address

Site # 724001

Sevilla, , 41009