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 approximately 16 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
222
Dose A
Dose B
Dose C
Dose D
Placebo
Local Site # 840012
Birmingham, Alabama, United States
Local Site # 840006
Birmingham, Alabama, United States
Local Site # 840028
Phoenix, Arizona, United States
Local Site # 840032
Bryant, Arkansas, United States
Local Site # 840041
North Little Rock, Arkansas, United States
Local Site # 840031
Psoriasis Area and Severity Index (PASI) Efficacy at 16 weeks
Proportion of subjects achieving PASI-75 at Week 16
Time frame: Day 1 of Placebo-controlled treatment period to week 16
Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate through study completion
Incidence of AEs and SAEs
Time frame: Screening through study completion, up to 76 weeks
Static Physician's Global Assessment (sPGA) Efficacy at 16 weeks
Proportion of participants achieving a sPGA score of 0 (clear) or 1 (almost clear) at Week 16
Time frame: Day 1 of Placebo-controlled treatment period to week 16
PASI Efficacy at 16 weeks
Change and percent change from baseline in PASI at Week 16
Time frame: Day 1 of Placebo-controlled treatment period to week 16
PASI Efficacy at 16 weeks
Proportion of participants achieving PASI-90 at Week 16
Time frame: Day 1 of Placebo-controlled treatment period to week 16
PASI Efficacy at 16 weeks
Proportion of participants achieving PASI-100 at Week 16
Time frame: Day 1 of Placebo-controlled treatment period to week 16
Dermatology Life Quality Index (DLQI) Efficacy at 16 weeks
Change from baseline in DLQI scores at Week 16
Time frame: Day 1 of Placebo-controlled treatment period to week 16
Body Surface Area (BSA) Efficacy at 16 weeks
Change from baseline in BSA at Week 16
Time frame: Day 1 of Placebo-controlled treatment period to week 16
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Fountain Valley, California, United States
Local Site # 840026
Lomita, California, United States
Local Site # 840019
Santa Rosa, California, United States
Local Site # 840003
Sherman Oaks, California, United States
Local Site # 840040
Boca Raton, Florida, United States
...and 53 more locations