VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis
- Conditions
- Psoriasis
- Interventions
- Registration Number
- NCT05655299
- Lead Sponsor
- Ventyx Biosciences, Inc
- Brief Summary
This is a study to understand if taking VTX958 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), a 16-week Long Term Extension (LTE) period, a 36-week Open Label Extension (OLE) period and a 4-week Follow-Up Period. The maximal duration of treatment will be 17 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 222
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VTX958 Dose A VTX958 Dose A - VTX958 Dose B VTX958 Dose B - VTX958 Dose C VTX958 Dose C - Placebo Placebo - VTX958 Dose D VTX958 Dose D -
- Primary Outcome Measures
Name Time Method Psoriasis Area and Severity Index (PASI) Efficacy at 16 weeks Day 1 of Placebo-controlled treatment period to week 16 Proportion of subjects achieving PASI-75 at Week 16
Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate through study completion Screening through study completion, up to 76 weeks Incidence of AEs and SAEs
- Secondary Outcome Measures
Name Time Method Dermatology Life Quality Index (DLQI) Efficacy at 16 weeks Day 1 of Placebo-controlled treatment period to week 16 Change from baseline in DLQI scores at Week 16
Body Surface Area (BSA) Efficacy at 16 weeks Day 1 of Placebo-controlled treatment period to week 16 Change from baseline in BSA at Week 16
Static Physician's Global Assessment (sPGA) Efficacy at 16 weeks Day 1 of Placebo-controlled treatment period to week 16 Proportion of participants achieving a sPGA score of 0 (clear) or 1 (almost clear) at Week 16
PASI Efficacy at 16 weeks Day 1 of Placebo-controlled treatment period to week 16 Proportion of participants achieving PASI-100 at Week 16
Trial Locations
- Locations (63)
Local Site # 616003
🇵🇱Ostrowiec Świętokrzyski, Poland
Local Site # 124010
🇨🇦Mississauga, Canada
Local Site # 124008
🇨🇦Québec City, Canada
Local Site # 124007
🇨🇦Peterborough, Canada
Local Site # 616016
🇵🇱Białystok, Poland
Local Site # 840009
🇺🇸Portland, Oregon, United States
Local Site # 840006
🇺🇸Birmingham, Alabama, United States
Local Site # 840005
🇺🇸Indianapolis, Indiana, United States
Local Site # 840028
🇺🇸Phoenix, Arizona, United States
Local Site # 840035
🇺🇸Clarksville, Indiana, United States
Local Site # 840004
🇺🇸Tampa, Florida, United States
Local Site # 840001
🇺🇸Tampa, Florida, United States
Local Site # 124006
🇨🇦Windsor, Canada
Local Site # 840012
🇺🇸Birmingham, Alabama, United States
Local Site # 840032
🇺🇸Bryant, Arkansas, United States
Local Site # 840041
🇺🇸North Little Rock, Arkansas, United States
Local Site # 840031
🇺🇸Fountain Valley, California, United States
Local Site # 840019
🇺🇸Santa Rosa, California, United States
Local Site # 840026
🇺🇸Lomita, California, United States
Local Site # 840003
🇺🇸Sherman Oaks, California, United States
Local Site # 840040
🇺🇸Boca Raton, Florida, United States
Local Site # 840011
🇺🇸Doral, Florida, United States
Local Site # 840023
🇺🇸Hialeah, Florida, United States
Local Site # 840044
🇺🇸North Miami Beach, Florida, United States
Local Site # 840021
🇺🇸Miami Lakes, Florida, United States
Local Site # 840010
🇺🇸Ocala, Florida, United States
Local Site # 840030
🇺🇸Plainfield, Indiana, United States
Local Site # 840029
🇺🇸Marietta, Georgia, United States
Local Site # 840008
🇺🇸Brighton, Massachusetts, United States
Local Site # 840022
🇺🇸Rockville, Maryland, United States
Local Site # 840016
🇺🇸Bay City, Michigan, United States
Local Site # 840024
🇺🇸Saint Joseph, Missouri, United States
Local Site # 840007
🇺🇸Fort Gratiot, Michigan, United States
Local Site # 840042
🇺🇸Wilmington, North Carolina, United States
Local Site # 840034
🇺🇸New Brighton, Minnesota, United States
Local Site # 840002
🇺🇸Troy, Michigan, United States
Local Site # 840027
🇺🇸Portsmouth, New Hampshire, United States
Local Site # 840038
🇺🇸Rapid City, South Dakota, United States
Local Site # 840037
🇺🇸Mason, Ohio, United States
Local Site #616010
🇵🇱Lublin, Poland
Local Site # 840039
🇺🇸Pflugerville, Texas, United States
Local Site # 840015
🇺🇸Murfreesboro, Tennessee, United States
Local Site # 840014
🇺🇸Spokane, Washington, United States
Local Site # 124012
🇨🇦Fredericton, Canada
Local Site # 124011
🇨🇦Oshawa, Canada
Local Site # 124002
🇨🇦Montréal, Canada
Local Site # 124004
🇨🇦North Bay, Canada
Local Site # 124005
🇨🇦Toronto, Canada
Local Site # 616001
🇵🇱Katowice, Poland
Local Site # 616015
🇵🇱Białystok, Poland
Local Site # 616011
🇵🇱Mikołów, Poland
Local Site # 616014
🇵🇱Kraków, Poland
Local Site # 616009
🇵🇱Nowa Sól, Poland
Local Site # 616008
🇵🇱Poznań, Poland
Local Site # 616007
🇵🇱Szczecin, Poland
Local Site # 616005
🇵🇱Warszawa, Poland
Local Site # 616013
🇵🇱Szczecin, Poland
Local Site # 616002
🇵🇱Wrocław, Poland
Local Site # 616004
🇵🇱Łódź, Poland
Local Site # 616006
🇵🇱Wrocław, Poland
Local Site # 616018
🇵🇱Wrocław, Poland
Local Site # 840045
🇺🇸West Palm Beach, Florida, United States
Local Site # 840013
🇺🇸Louisville, Kentucky, United States