Psoriasis Clinical Trial
VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA)
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.
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.
Eligibility 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
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There are 30 Locations for this study
Phoenix Arizona, 85032, United States
Newport Beach California, 92663, United States
Clearwater Florida, 33765, United States
Miami Lakes Florida, 33014, United States
Lexington Kentucky, 40504, United States
Okemos Michigan, 48864, United States
Saint Clair Shores Michigan, 48081, United States
Eagan Minnesota, 55121, United States
Middleburg Heights Ohio, 44130, United States
Duncansville Pennsylvania, 16635, United States
Jackson Tennessee, 38305, United States
Baytown Texas, 77521, United States
Lubbock Texas, 79410, United States
Mesquite Texas, 75150, United States
Beckley West Virginia, 25802, United States
South Charleston West Virginia, 25309, United States
Hlučín , 748 0, Czechia
Ostrava , 702 0, Czechia
Pardubice , 530 0, Czechia
Praha 5 , 150 0, Czechia
Zlín , 760 0, Czechia
Hamburg , 20095, Germany
Budapest , 1036, Hungary
Hódmezővásárhely , 6800, Hungary
Toruń , 87-10, Poland
Wrocław , 52-41, Poland
Wrocław , 53-22, Poland
A Coruña , 15006, Spain
Málaga , 29009, Spain
Mérida , 6800, Spain
Sevilla , 41009, Spain
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