A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque… (NCT06586112) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis
United States912 participantsStarted 2024-07-25
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males or females, age ≥18 years
✓. Diagnosis of plaque psoriasis for ≥6 months
✓. Plaques covering ≥10% of BSA
✓. PASI ≥12
✓. sPGA ≥3
✓. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception
Exclusion criteria
✕. Nonplaque psoriasis or other inflammatory skin conditions
✕. immune-mediated conditions commonly associated with psoriasis (eg inflammatory bowel disease). Participants with psoriatic arthritis may participate
✕. Pregnant, lactating, or planning to get pregnant during the study
✕. Use of drugs prior to Study Day 1 that treat or may affect psoriasis:
What they're measuring
1
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