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

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: NCT06586112
Run by: Alumis Inc
People needed: 912
Starts: 2024-07-25
Expected to finish: 2025-11-20
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). 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:
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
Participants 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 participant's immune status
Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
History of any immune-mediated or inflammatory medical condition for which participants requires current systemic corticosteroids
Stable doses of inhaled corticosteroids for treatment of asthma are allowed
Known current malignancy or current evaluation for a potential malignancy or history of malignancy within the past 5 years prior to screening, except for adequately treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
Live vaccines within 4 weeks prior to Study Day 1
Participant has planned surgery during the study period

Where it is running

Scottsdale Clinical Trials — Scottsdale, Arizona, United States
Northwest Arkansas Clinical Trials Center (NWACTC), PLLC — Rogers, Arkansas, United States
Exalt Clinical Research — Chula Vista, California, United States
California Dermatology & Clinical Research Institute — Encinitas, California, United States
First OC Dermatology Research Inc — Fountain Valley, California, United States
Marvel Clinical Research, LLC — Huntington Beach, California, United States
Sunwise Clinical Research, LLC — Lafayette, California, United States
Wallace Medical Group Inc — Los Angeles, California, United States
Northridge Clinical Trials - Elite Clinical Network — Northridge, California, United States
Pasadena Clinical Trials — Pasadena, California, United States
Therapeutics Clinical Research — San Diego, California, United States
Unison Clinical Trials/ Shahram Jacobs MD — Sherman Oaks, California, United States
Olive View - UCLA Education & Research Institute — Sylmar, California, United States
California Dermatology Institute - Thousand Oaks — Thousand Oaks, California, United States
Clearlyderm Dermatology - West Boca Raton — Boca Raton, Florida, United States
Driven Clinical Research — Coral Gables, Florida, United States
Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
Glick Skin Institute - Margate — Margate, Florida, United States
San Marcus Research Clinic, Inc - Miami — Miami Lakes, Florida, United States
Savin Medical Group LLC — Miami Lakes, Florida, United States
Oceanic Research Group — North Miami Beach, Florida, United States
LENUS Research — Sweetwater, Florida, United States
Caban Skin Institute — Tampa, Florida, United States
ForCare Medical Center — Tampa, Florida, United States
Alliance Dermatology — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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