Psoriasis Clinical Trial
VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis
Summary
This is a study to understand if taking VTX958 daily orally is safe and effective in participants diagnosed with moderate to severe psoriasis (PsO). Approximately 200 patients will take VTX958 Dose A, VTX958 Dose B, VTX958 Dose C, VTX958 Dose D, or placebo.
The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 16-week double-blind period (a participant receives active Dose A, Dose B, Dose C, Dose D, or placebo), and a 4-week Follow-Up Period. The maximal duration of treatment will be 4 months
Eligibility Criteria
Inclusion Criteria:
Male or female participant aged 18 years or older.
History of primarily plaque psoriasis for at least 6 months prior to the screening visit.
Has had stable psoriasis conditions for at least 3 months before screening.
Has moderate to severe plaque psoriasis as defined by a PASI score of ≥ 12 and an sPGA score of ≥ 3 at screening and Day 1.
Has plaque psoriasis covering ≥ 10% of the total BSA at screening and Day 1.
Deemed by the investigator to be eligible for phototherapy or systemic therapy.
Females of childbearing potential must agree to use a highly effective contraceptive method from at least 4 weeks prior to Day 1 until at least 4 weeks after the last dose of study product.
Exclusion Criteria:
Female who is breastfeeding, pregnant, lactating, or who is planning to become pregnant during the study.
Has evidence of erythrodermic, pustular, predominantly inverse or guttate psoriasis, or drug-induced psoriasis.
History of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
Participant is known to have immune deficiency or is immunocompromised.
Has immune-mediated conditions commonly associated with psoriasis, such as psoriatic arthritis, active uveitis, inflammatory bowel disease, that currently require systemic treatment (including corticosteroids, immunosuppressants, or biologics).
Note: Participants with immune-mediated conditions commonly associated with psoriasis that do not require systemic treatment may be included in the study.
Has used any topical medication that could affect psoriasis (including corticosteroids, retinoids, vitamin D analogues [such as calcipotriol], Janus kinase [JAK] inhibitors, or tar) within 2 weeks prior to Day 1.
Has used any systemic treatment that could affect psoriasis (including corticosteroids, oral retinoids, immunosuppressive medication, anakinra, methotrexate, cyclosporine, oral JAK inhibitors, or apremilast) within 4 weeks prior to Day 1.
Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed.
Participant has received any ultraviolet B (UVB) phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day 1.
Participant has had psoralen and ultraviolet A (PUVA) treatment within 4 weeks prior to Day 1.
Participant has received treatment with an investigational or marketed TYK2 inhibitor.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 38 Locations for this study
Birmingham Alabama, 35205, United States
Birmingham Alabama, 35244, United States
Phoenix Arizona, 85032, United States
Bryant Arkansas, 72022, United States
North Little Rock Arkansas, 72117, United States
Fountain Valley California, 92708, United States
Lomita California, 90717, United States
Santa Rosa California, 95405, United States
Sherman Oaks California, 91403, United States
Boca Raton Florida, 33486, United States
Doral Florida, 33122, United States
Hialeah Florida, 33012, United States
Miami Lakes Florida, 33104, United States
North Miami Beach Florida, 33162, United States
Ocala Florida, 34470, United States
Tampa Florida, 33607, United States
Tampa Florida, 33613, United States
West Palm Beach Florida, 33406, United States
Marietta Georgia, 30060, United States
Clarksville Indiana, 47129, United States
Indianapolis Indiana, 46250, United States
Plainfield Indiana, 46168, United States
Louisville Kentucky, 40241, United States
Rockville Maryland, 20850, United States
Brighton Massachusetts, 02135, United States
Bay City Michigan, 48706, United States
Fort Gratiot Michigan, 48059, United States
Troy Michigan, 48084, United States
New Brighton Minnesota, 55112, United States
Saint Joseph Missouri, 64506, United States
Portsmouth New Hampshire, 03801, United States
Wilmington North Carolina, 28405, United States
Mason Ohio, 45040, United States
Portland Oregon, 97223, United States
Rapid City South Dakota, 57702, United States
Murfreesboro Tennessee, 37130, United States
Pflugerville Texas, 78660, United States
Spokane Washington, 99202, United States
Fredericton , , Canada
Mississauga , , Canada
Montréal , , Canada
North Bay , , Canada
Oshawa , , Canada
Peterborough , , Canada
Québec City , , Canada
Toronto , , Canada
Windsor , , Canada
Białystok , , Poland
Białystok , , Poland
Katowice , , Poland
Kraków , , Poland
Lublin , , Poland
Mikołów , , Poland
Nowa Sól , , Poland
Ostrowiec Świętokrzyski , , Poland
Poznań , , Poland
Szczecin , , Poland
Szczecin , , Poland
Warszawa , , Poland
Wrocław , , Poland
Wrocław , , Poland
Wrocław , , Poland
Łódź , , Poland
How clear is this clinincal trial information?