Overview

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

Status:
Recruiting
Trial end date:
2024-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ventyx Biosciences, Inc
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