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

Description

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.

Conditions

Plaque Psoriasis

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Study Overview

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Study Details

Study overview

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.

A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (ONWARD2)

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

Condition
Plaque Psoriasis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Total Skin and Beauty Dermatology Center, PC, Birmingham, Alabama, United States, 35203

Chandler

Chandler Clinical Trials, Chandler, Arizona, United States, 85224

Phoenix

Medical Dermatology Specialists, Phoenix, Arizona, United States, 85006

Tucson

Noble Clinical Research, Tucson, Arizona, United States, 85704

Encino

Raoof MD, Encino, California, United States, 91436

Long Beach

Long Beach Research Institute, Long Beach, California, United States, 90805

Los Angeles

Dermatology Research Associates, Los Angeles, California, United States, 90045

Pomona

Empire Clinical Research - Pomona, Pomona, California, United States, 91767

Santa Ana

Southern California Clinical Research, Santa Ana, California, United States, 92701

Santa Monica

Clinical Science Institute Dermatology Institute, Santa Monica, California, United States, 90404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Males or females, age ≥18 years
  • 2. Diagnosis of plaque psoriasis for ≥6 months
  • 3. Plaques covering ≥10% of BSA
  • 4. PASI ≥12
  • 5. sPGA ≥3
  • 6. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception
  • 1. Nonplaque psoriasis or other inflammatory skin conditions
  • 2. Immune-mediated conditions commonly associated with psoriasis (eg inflammatory bowel disease). Patients with psoriatic arthritis may participate
  • 3. Pregnant, lactating, or planning to get pregnant during the study
  • 4. 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
  • 5. Lack of clinical response to a TYK2, IL-12, or IL-23 targeted psoriasis treatment
  • 6. Patients with QTcF \>450 msec (males) or \>470 msec (females) at Screening
  • 7. Unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months
  • 8. Evidence of recent or recurrent herpes zoster or herpes simplex viral infection
  • 9. Evidence of active infection or positive test result for hepatitis B, hepatitis C, HIV or TB
  • 10. History of serious bacterial, fungal, or viral infections that led to hospitalization, or any recent serious infection requiring antibiotic treatment
  • 11. Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the patient's immune status
  • 12. Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
  • 13. History of any immune-mediated or inflammatory medical condition for which patient requires current systemic corticosteroids

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alumis Inc,

Study Record Dates

2026-06