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

Sponsor

Ventyx Biosciences, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05715125

Collaborator

(none)

195

Enrollment

Locations

Arms

Anticipated Duration (Months)

97.5

Patients Per Site

7.5

Patients Per Site Per Month

Study Details

Study Description

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. The study will include 16 weeks of treatment and a 30-day follow-up period.

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis	Drug: Dose A VTX958 Drug: Dose B VTX958 Drug: Placebo	Phase 2

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. The study consists of a 30-day screening period, a 16 week double-blind treatment period, and a 30 day follow-up period.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

195 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The study has a double-blind design, meaning that the participant, care provider, and investigator will not know what treatment group each participant has been assigned to. This blinding will last from randomization until the end of the study.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 31, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Proportion of participants achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 16 [Week 16]
Number of participants reaching ACR20 at week 16, compared to the total number of participants in each cohort
Incidence of Treatment Emergent Adverse Events (TEAEs) from week 0 through week 16 [Week 16]
The number and proportion of participants who have at least 1 TEAE after exposure to the study drug

Secondary Outcome Measures

Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) scores at Week 16 [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.
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 [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.
Change from baseline in Short Form Health Survey - 36 items (SF-36) physical component score (PCS) at Week 16 [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).
Proportion of participants achieving 50% improvement in American College of Rheumatology criteria (ACR50) at Week 16 [Week 16]
Number of participants reaching ACR50 at week 16, compared to the total number of participants in each cohort
Proportion of participants achieving 70% improvement in American College of Rheumatology criteria (ACR70) at Week 16 [Week 16]
Number of participants reaching ACR70 at week 16, compared to the total number of participants in each cohort

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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