A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001

Completed · Phase 3 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT06588738

Run by

Alumis Inc

People needed

862

Starts

2024-08-20

Expected to finish

2025-12-18

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Nonplaque psoriasis or other inflammatory skin conditions
• Immune-mediated conditions commonly associated with psoriasis (eg inflammatory bowel disease). Patients 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:
• Topical within 2 weeks
• Phototherapy or any systemic treatments within 4 weeks
• Any biologic agent targeted to IL-12 or IL-23 within 6 months, oral IL-12 or IL-23 or TNFα inhibitor within 2 months, or IL-17 within 4 months
• Systemic immunosuppressants or immunomodulatory drugs within 4 weeks
• Modulators of B cells within 6 months, or T cells within 3 months
• JAK inhibitors or TYK2 inhibitors within 4 weeks
• PDE4 inhibitor within 2 months
• Any investigational agent, within 30 days or 5 half-lives or is currently enrolled in an investigational study
• Lack of clinical response to a TYK2, IL-12, or IL-23 targeted psoriasis treatment
• Patients with QTcF >450 msec (males) or >470 msec (females) at Screening
• Unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months
• Evidence of recent or recurrent herpes zoster or herpes simplex viral infection
• Evidence of active infection or positive test result for hepatitis B, hepatitis C, HIV or TB
• History of serious bacterial, fungal, or viral infections that led to hospitalization, or any recent serious infection requiring antibiotic treatment
• Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the patient's immune status
• Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
• History of any immune-mediated or inflammatory medical condition for which patient requires current systemic corticosteroids

Where it is running

• 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
• 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
• Southern California Clinical Research — Santa Ana, California, United States
• Clinical Science Institute Dermatology Institute — Santa Monica, California, United States
• FXM Clinical Research Ft. Lauderdale LLC — Fort Lauderdale, Florida, United States
• Direct Helpers Research Center (DHRC) — Hialeah, Florida, United States
• AppleMed Research Group under WCG — Miami, Florida, United States
• FAX Pharma Clinical Research Inc — Miami, Florida, United States
• FXM Clinical Research - Miami LLC — Miami, Florida, United States
• Las Mercedes Medical Research — Miami, Florida, United States
• FXM Clinical Research Miramar LLC — Miramar, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• DS Research of Southern Indiana — Clarksville, Indiana, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• DS Research of Kentucky — Louisville, Kentucky, United States
• Michigan Center for Research Company — Clarkston, Michigan, United States
• Henry Ford Medical Center - Farmington Road — Detroit, Michigan, United States
• Total Skin and Beauty Dermatology Center, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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