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

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

222

Study ID:

NCT05655299

Recruitment Status:

Active, not recruiting

Sponsor:

Ventyx Biosciences, Inc

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There are 38 Locations for this study

See Locations Near You

Local Site # 840012
Birmingham Alabama, 35205, United States
Local Site # 840006
Birmingham Alabama, 35244, United States
Local Site # 840028
Phoenix Arizona, 85032, United States
Local Site # 840032
Bryant Arkansas, 72022, United States
Local Site # 840041
North Little Rock Arkansas, 72117, United States
Local Site # 840031
Fountain Valley California, 92708, United States
Local Site # 840026
Lomita California, 90717, United States
Local Site # 840019
Santa Rosa California, 95405, United States
Local Site # 840003
Sherman Oaks California, 91403, United States
Local Site # 840040
Boca Raton Florida, 33486, United States
Local Site # 840011
Doral Florida, 33122, United States
Local Site # 840023
Hialeah Florida, 33012, United States
Local Site # 840021
Miami Lakes Florida, 33104, United States
Local Site # 840044
North Miami Beach Florida, 33162, United States
Local Site # 840010
Ocala Florida, 34470, United States
Local Site # 840004
Tampa Florida, 33607, United States
Local Site # 840001
Tampa Florida, 33613, United States
Local Site # 840045
West Palm Beach Florida, 33406, United States
Local Site # 840029
Marietta Georgia, 30060, United States
Local Site # 840035
Clarksville Indiana, 47129, United States
Local Site # 840005
Indianapolis Indiana, 46250, United States
Local Site # 840030
Plainfield Indiana, 46168, United States
Local Site # 840013
Louisville Kentucky, 40241, United States
Local Site # 840022
Rockville Maryland, 20850, United States
Local Site # 840008
Brighton Massachusetts, 02135, United States
Local Site # 840016
Bay City Michigan, 48706, United States
Local Site # 840007
Fort Gratiot Michigan, 48059, United States
Local Site # 840002
Troy Michigan, 48084, United States
Local Site # 840034
New Brighton Minnesota, 55112, United States
Local Site # 840024
Saint Joseph Missouri, 64506, United States
Local Site # 840027
Portsmouth New Hampshire, 03801, United States
Local Site # 840042
Wilmington North Carolina, 28405, United States
Local Site # 840037
Mason Ohio, 45040, United States
Local Site # 840009
Portland Oregon, 97223, United States
Local Site # 840038
Rapid City South Dakota, 57702, United States
Local Site # 840015
Murfreesboro Tennessee, 37130, United States
Local Site # 840039
Pflugerville Texas, 78660, United States
Local Site # 840014
Spokane Washington, 99202, United States
Local Site # 124012
Fredericton , , Canada
Local Site # 124010
Mississauga , , Canada
Local Site # 124002
Montréal , , Canada
Local Site # 124004
North Bay , , Canada
Local Site # 124011
Oshawa , , Canada
Local Site # 124007
Peterborough , , Canada
Local Site # 124008
Québec City , , Canada
Local Site # 124005
Toronto , , Canada
Local Site # 124006
Windsor , , Canada
Local Site # 616015
Białystok , , Poland
Local Site # 616016
Białystok , , Poland
Local Site # 616001
Katowice , , Poland
Local Site # 616014
Kraków , , Poland
Local Site #616010
Lublin , , Poland
Local Site # 616011
Mikołów , , Poland
Local Site # 616009
Nowa Sól , , Poland
Local Site # 616003
Ostrowiec Świętokrzyski , , Poland
Local Site # 616008
Poznań , , Poland
Local Site # 616007
Szczecin , , Poland
Local Site # 616013
Szczecin , , Poland
Local Site # 616005
Warszawa , , Poland
Local Site # 616002
Wrocław , , Poland
Local Site # 616006
Wrocław , , Poland
Local Site # 616018
Wrocław , , Poland
Local Site # 616004
Łódź , , Poland

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

222

Study ID:

NCT05655299

Recruitment Status:

Active, not recruiting

Sponsor:


Ventyx Biosciences, Inc

How clear is this clinincal trial information?

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