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

Ventyx Biosciences

Status and phase: Terminated; Phase 2

Conditions: Psoriatic Arthritis

Treatments: Drug: Placebo; Drug: Dose A VTX958; Drug: Dose B VTX958

Study type: Interventional

Funder types: Industry

Identifiers

NCT05715125

VTX958-203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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205 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

VTX958 Dose A

Experimental group

Treatment:

Drug: Dose A VTX958

VTX958 Dose B

Experimental group

Treatment:

Drug: Dose B VTX958