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

Psoriatic Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05715125
• Other study ID #: VTX958-203
• Status: Terminated
• Phase: Phase 2
• Start date: January 31, 2023
• Est. completion date: January 2, 2024

Study information

• Verified date: January 2024
• Source: Ventyx Biosciences, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 205
• Est. completion date: January 2, 2024
• Est. primary completion date: January 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Dose A VTX958
Dose A VTX958
• Dose B VTX958
Dose B VTX958
• Placebo
Placebo

Locations

Country	Name	City	State
Bulgaria	Site # 100004	Haskovo
Bulgaria	Site # 100001	Plovdiv
Bulgaria	Site # 100002	Plovdiv
Czechia	Site # 203004	Hlucín
Czechia	Site # 203001	Ostrava
Czechia	Site # 203003	Pardubice
Czechia	Site # 203005	Praha 5
Czechia	Site # 203002	Zlín
Germany	Site # 276002	Berlin
Germany	Site # 276001	Hamburg
Hungary	Site # 348003	Budapest
Hungary	Site # 348001	Hódmezovásárhely
Hungary	Site # 348004	Kistarcsa
Poland	Site # 616015	Gdynia
Poland	Site # 616007	Katowice
Poland	Site # 616010	Kraków
Poland	Site # 616009	Lódz
Poland	Site # 616012	Lódz
Poland	Site # 616014	Lódz
Poland	Site # 616013	Lublin
Poland	Site # 616002	Nadarzyn
Poland	Site # 616011	Olsztyn
Poland	Site # 616004	Poznan
Poland	Site # 616008	Torun
Poland	Site # 616006	Warszawa
Poland	Site #616001	Warszawa
Poland	Site # 616003	Wroclaw
Poland	Site # 616016	Wroclaw
Spain	Site # 724002	A Coruña
Spain	Site # 724005	Lleida
Spain	Site # 724001	Sevilla
United States	Site # 840010	Baytown	Texas
United States	Site # 840011	Beckley	West Virginia
United States	Site # 840004	Clearwater	Florida
United States	Site # 840007	Duncansville	Pennsylvania
United States	Site # 840019	Eagan	Minnesota
United States	Site # 840017	Lexington	Kentucky
United States	Site # 840006	Lubbock	Texas
United States	Site # 840015	Mesquite	Texas
United States	Site # 840014	Miami Lakes	Florida
United States	Site # 840003	Middleburg Heights	Ohio
United States	Site # 840016	Newport Beach	California
United States	Site # 840018	Okemos	Michigan
United States	Site # 840001	Phoenix	Arizona
United States	Site #840012	Saint Clair Shores	Michigan
United States	Site # 840008	South Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Ventyx Biosciences, Inc

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Germany,  Hungary,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 16	Number of participants reaching ACR20 at week 16, compared to the total number of participants in each cohort	Week 16
Primary	Incidence of Treatment Emergent Adverse Events (TEAEs) from week 0 through week 16	The number and proportion of participants who have at least 1 TEAE after exposure to the study drug	Week 16
Secondary	Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) scores at 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
Secondary	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	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
Secondary	Change from baseline in Short Form Health Survey - 36 items (SF-36) physical component score (PCS) at 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
Secondary	Proportion of participants achieving 50% improvement in American College of Rheumatology criteria (ACR50) at Week 16	Number of participants reaching ACR50 at week 16, compared to the total number of participants in each cohort	Week 16
Secondary	Proportion of participants achieving 70% improvement in American College of Rheumatology criteria (ACR70) at Week 16	Number of participants reaching ACR70 at week 16, compared to the total number of participants in each cohort	Week 16