NCT05715125

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Ventyx Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	Dose A VTX958	Dose A VTX958
DRUG	Dose B VTX958	Dose B VTX958
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-01-31
• Primary completion: 2024-01-02
• Completion: 2024-01-02
• First posted: 2023-02-06
• Last updated: 2024-12-27

Locations

46 sites across 7 countries: United States, Bulgaria, Czechia, Germany, Hungary, Poland, Spain

Regulatory

• FDA-regulated drug study