NCT05715125TerminatedPhase 2
VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA)
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
Source: ClinicalTrials.gov · Last updated 27 Dec 2024
Reason given: sponsor decision
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 205 (actual)
- First submitted
- 19 Jan 2023
- Start date
- 31 Jan 2023
- Primary completion date
- 2 Jan 2024
- Lead sponsor
- Ventyx Biosciences, Inc
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT05715125
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has inflammatory bowel disease or active uveitis
- Has a history of chronic or recurrent infectious disease
- Has hepatitis B or hepatitis C infection, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or active tuberculosis (TB) at screening
Other
- Has non-plaque psoriasis at Screening or Day 1
- Has a known immune deficiency or is immunocompromised
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (46)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - | Haskovo | Bulgaria | Unknown status |
| - | Plovdiv | Bulgaria | Unknown status |
| - | Plovdiv | Bulgaria | Unknown status |
| - | Hlučín | Czechia | Unknown status |
| - | Ostrava | Czechia | Unknown status |
| - | Pardubice | Czechia | Unknown status |
| - | Prague | Czechia | Unknown status |
| - | Zlín | Czechia | Unknown status |
| - | Berlin | Germany | Unknown status |
| - | Hamburg | Germany | Unknown status |
| - | A Coruña | Spain | Unknown status |
| - | Lleida | Spain | Unknown status |
| - | Seville | Spain | Unknown status |
| - | Budapest | Hungary | Unknown status |
| - | Hódmezővásárhely | Hungary | Unknown status |
| - | Kistarcsa | Hungary | Unknown status |
| - | Gdynia | Poland | Unknown status |
| - | Katowice | Poland | Unknown status |
| - | Krakow | Poland | Unknown status |
| - | Lodz | Poland | Unknown status |
| - | Lodz | Poland | Unknown status |
| - | Lodz | Poland | Unknown status |
| - | Lublin | Poland | Unknown status |
| - | Nadarzyn | Poland | Unknown status |
| - | Olsztyn | Poland | Unknown status |
| - | Poznan | Poland | Unknown status |
| - | Torun | Poland | Unknown status |
| - | Warsaw | Poland | Unknown status |
| - | Warsaw | Poland | Unknown status |
| - | Wroclaw | Poland | Unknown status |
| - | Wroclaw | Poland | Unknown status |
| - | Baytown | United States | Unknown status |
| - | Beckley | United States | Unknown status |
| - | Clearwater | United States | Unknown status |
| - | Duncansville | United States | Unknown status |
| - | Eagan | United States | Unknown status |
| - | Lexington | United States | Unknown status |
| - | Lubbock | United States | Unknown status |
| - | Mesquite | United States | Unknown status |
| - | Miami Lakes | United States | Unknown status |
| - | Middleburg Heights | United States | Unknown status |
| - | Newport Beach | United States | Unknown status |
| - | Okemos | United States | Unknown status |
| - | Phoenix | United States | Unknown status |
| - | Saint Clair Shores | United States | Unknown status |
| - | South Charleston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.