Clinical trial NCT05715125: VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Keywords: TYK2 inhibitor
Psoriatic arthritis
Ventyx
VTX958
Tranquility
Lead sponsor: Ventyx Biosciences, Inc
Sponsor class: INDUSTRY
First posted: 2023-02-06
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned at the beginning of the study to either Dose A, Dose B, or placebo group, where they stay for the remainder of the study.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Proportion of participants achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 16
timeFrame: Week 16
measure: Incidence of Treatment Emergent Adverse Events (TEAEs) from week 0 through week 16
timeFrame: Week 16
Secondary outcomes:
measure: Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) scores at Week 16
timeFrame: Week 16
measure: 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
timeFrame: Week 16
measure: Change from baseline in Short Form Health Survey - 36 items (SF-36) physical component score (PCS) at Week 16
timeFrame: Week 16
measure: Proportion of participants achieving 50% improvement in American College of Rheumatology criteria (ACR50) at Week 16
timeFrame: Week 16
measure: Proportion of participants achieving 70% improvement in American College of Rheumatology criteria (ACR70) at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site # 840001
state: Arizona
city: Newport Beach
country: United States
facility: Site # 840016
state: California
city: Clearwater
country: United States
facility: Site # 840004
state: Florida
city: Miami Lakes
country: United States
facility: Site # 840014
state: Florida
city: Lexington
country: United States
facility: Site # 840017
state: Kentucky
city: Okemos
country: United States
facility: Site # 840018
state: Michigan
city: Saint Clair Shores
country: United States
facility: Site #840012
state: Michigan
city: Eagan
country: United States
facility: Site # 840019
state: Minnesota
city: Middleburg Heights
country: United States
facility: Site # 840003
state: Ohio
city: Duncansville
country: United States
facility: Site # 840007
state: Pennsylvania
city: Baytown
country: United States
facility: Site # 840010
state: Texas
city: Lubbock
country: United States
facility: Site # 840006
state: Texas
city: Mesquite
country: United States
facility: Site # 840015
state: Texas
city: Beckley
country: United States
facility: Site # 840011
state: West Virginia
city: South Charleston
country: United States
facility: Site # 840008
state: West Virginia
city: Haskovo
country: Bulgaria
facility: Site # 100004
city: Plovdiv
country: Bulgaria
facility: Site # 100001
city: Plovdiv
country: Bulgaria
facility: Site # 100002
city: Hlučín
country: Czechia
facility: Site # 203004
city: Ostrava
country: Czechia
facility: Site # 203001
city: Pardubice
country: Czechia
facility: Site # 203003
city: Praha 5
country: Czechia
facility: Site # 203005
city: Zlín
country: Czechia
facility: Site # 203002
city: Berlin
country: Germany
facility: Site # 276002
city: Hamburg
country: Germany
facility: Site # 276001
city: Budapest
country: Hungary
facility: Site # 348003
city: Hódmezővásárhely
country: Hungary
facility: Site # 348001
city: Kistarcsa
country: Hungary
facility: Site # 348004
city: Gdynia
country: Poland
facility: Site # 616015
city: Katowice
country: Poland
facility: Site # 616007
city: Kraków
country: Poland
facility: Site # 616010
city: Lublin
country: Poland
facility: Site # 616013
city: Nadarzyn
country: Poland
facility: Site # 616002
city: Olsztyn
country: Poland
facility: Site # 616011
city: Poznań
country: Poland
facility: Site # 616004
city: Toruń
country: Poland
facility: Site # 616008
city: Warszawa
country: Poland
facility: Site # 616006
city: Warszawa
country: Poland
facility: Site #616001
city: Wrocław
country: Poland
facility: Site # 616003
city: Wrocław
country: Poland
facility: Site # 616016
city: Łódź
country: Poland
facility: Site # 616009
city: Łódź
country: Poland
facility: Site # 616012
city: Łódź
country: Poland
facility: Site # 616014
city: A Coruña
country: Spain
facility: Site # 724002
city: Lleida
country: Spain
facility: Site # 724005
city: Sevilla
country: Spain
facility: Site # 724001
Study officials:
affiliation: Ventyx Biosciences, Inc
name: Matt Cascino, MD
role: STUDY_DIRECTOR
References: