The goal of this clinical trial is to learn if ESK-001 works to treat moderate to severe plaque psoriasis. The main questions it aims to answer are: * Does ESK-001 reduce the severity of people's psoriasis? * How safe is ESK-001 in people with moderate to severe plaque psoriasis? The study includes 2 comparators: a placebo control (a 'dummy' tablet that does not contain the medicine ESK-001 but looks just like it) and an active control (apremilast, which is a medicine approved to treat psoriasis). People taking part in this study must be men or women aged at least 18 years and have had plaque psoriasis for at least 6 months, currently moderate to severe. Participants will: * take drug every day for 24 weeks. * visit the clinic for checkups and tests. * fill out questionnaires about their psoriasis, itch severity, and change in quality of life. * be assessed for health issues and side effects, physical examinations, vital signs, heart electrical activity measurements, and psychological health. * provide blood and urine samples.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
862
ESK-001
Placebo
Apremilast
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
Chandler Clinical Trials
Chandler, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Zenith Research Inc.
Beverly Hills, California, United States
Raoof MD
Encino, California, United States
To determine whether ESK-001 reduces the severity of psoriasis by 75% (using the PASI) or by at least 2 points (using sPGA score) compared to placebo
Proportion of patients achieving ≥75% reduction in PASI score. Proportion of patients achieving a score of 0 or 1 on sPGA.
Time frame: 16 weeks
To compare the Psoriasis Area and Severity Index (PASI-90 and PASI-100) between ESK-001 and placebo or apremilast
Proportion of patients achieving of ≥90% or 100% reduction in PASI
Time frame: 24 weeks
To compare the Psoriasis Area and Severity Index (PASI-75) between ESK-001 and apremilast
Proportion of patients achieving of ≥75% reduction in PASI
Time frame: 24 weeks
To compare the Static Physician's Global Assessment (sPGA-0/1) between ESK-001 and apremilast
Proportion of patients achieving a score of 0 or 1 on sPGA
Time frame: 24 weeks
To compare the affected body surface area (%BSA) between ESK-001 and placebo or apremilast
Change from baseline in %BSA
Time frame: 24 weeks
To compare the scalp specific Physician's Global Assessment (ssPGA) between ESK-001 and placebo or apremilast
Proportion of patients achieving a score of 0 or 1 on ssPGA
Time frame: 24 weeks
To compare the Psoriasis Symptoms and Signs Diary (PSSD) between ESK-001 and placebo or apremilast
Proportion of patients achieving a score of 0
Time frame: 24 weeks
To compare the Dermatology Life Quality Index (DLQI) between ESK-001 and placebo or apremilast
Proportion of patients achieving a score of 0 or 1
Time frame: 24 weeks
To compare the Pruritus numeric rating scale (NRS) between ESK-001 and placebo
Change from baseline in Pruritus NRS (scale is from 0 (no pain) to 10 (severe pain)).
Time frame: 24 weeks
Proportion of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: 24 weeks
To characterize the pharmacokinetics of ESK-001
Maximum \[Cmax\] and minimum \[Cmin\] plasma concentration
Time frame: 24 weeks
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Long Beach Research Institute
Long Beach, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Empire Clinical Research - Pomona
Pomona, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
UC San Diego
San Diego, California, United States
...and 114 more locations