ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (ONWARD1)

Quick Facts

Study Start:2024-07-25

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06586112

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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). Participants 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. Participants 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 participant'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 participants requires current systemic corticosteroids 14. 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 15. Live vaccines within 4 weeks prior to Study Day 1 16. Participant has planned surgery during the study period 17. Any acute or chronic illness/condition or evidence of an unstable clinical condition that, in the opinion of the Investigator, will substantially increase the risk to the participant if he or she participates in the study 18. History of mental illness within the last 5 years, unless receiving a fixed regimen of psychiatric medications for at least 6 months before screening or has not required or been prescribed any psychiatric medication within 12 months before screening 19. Evidence of severe depressive symptoms or active suicidal ideation or behavior

Inclusion Criteria

Exclusion 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). Participants 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. Participants 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 participant'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 participants requires current systemic corticosteroids
14. 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
15. Live vaccines within 4 weeks prior to Study Day 1
16. Participant has planned surgery during the study period
17. Any acute or chronic illness/condition or evidence of an unstable clinical condition that, in the opinion of the Investigator, will substantially increase the risk to the participant if he or she participates in the study
18. History of mental illness within the last 5 years, unless receiving a fixed regimen of psychiatric medications for at least 6 months before screening or has not required or been prescribed any psychiatric medication within 12 months before screening
19. Evidence of severe depressive symptoms or active suicidal ideation or behavior

Contacts and Locations

Study Locations (Sites)

Alliance Dermatology

Phoenix, Arizona, 85032

United States

Scottsdale Clinical Trials

Scottsdale, Arizona, 85260

United States

Northwest Arkansas Clinical Trials Center (NWACTC), PLLC

Rogers, Arkansas, 72758-8600

United States

Exalt Clinical Research

Chula Vista, California, 91910

United States

California Dermatology & Clinical Research Institute

Encinitas, California, 92024-7700

United States

First OC Dermatology Research Inc

Fountain Valley, California, 92708

United States

Marvel Clinical Research, LLC

Huntington Beach, California, 92647

United States

Sunwise Clinical Research, LLC

Lafayette, California, 94549

United States

Wallace Medical Group Inc

Los Angeles, California, 90056

United States

Northridge Clinical Trials - Elite Clinical Network

Northridge, California, 91325

United States

Pasadena Clinical Trials

Pasadena, California, 91101

United States

Therapeutics Clinical Research

San Diego, California, 92123

United States

Unison Clinical Trials/ Shahram Jacobs MD

Sherman Oaks, California, 91403-1814

United States

Olive View - UCLA Education & Research Institute

Sylmar, California, 91342

United States

California Dermatology Institute - Thousand Oaks

Thousand Oaks, California, 91320-2130

United States

Clearlyderm Dermatology - West Boca Raton

Boca Raton, Florida, 33428

United States

Driven Clinical Research

Coral Gables, Florida, 33134

United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216

United States

Accel Research Sites - Maitland

Maitland, Florida, 32751

United States

Glick Skin Institute - Margate

Margate, Florida, 33063-7011

United States

San Marcus Research Clinic, Inc - Miami

Miami Lakes, Florida, 33014

United States

Savin Medical Group LLC

Miami Lakes, Florida, 33014

United States

Oceanic Research Group

North Miami Beach, Florida, 33169

United States

LENUS Research

Sweetwater, Florida, 33172

United States

Caban Skin Institute

Tampa, Florida, 33607

United States

ForCare Medical Center

Tampa, Florida, 33613-1244

United States

Skin Care Physicians of Georgia - Warner Robins

Macon, Georgia, 31217

United States

Velocity Clinical Research, Boise

Meridian, Idaho, 83642

United States

MetroMed Clinical Trials

Chicago, Illinois, 60614-3625

United States

Arlington Dermatology

Rolling Meadows, Illinois, 60008

United States

NorthShore Medical Group - Dermatology - Skokie

Skokie, Illinois, 60077-1049

United States

Dundee Dermatology

West Dundee, Illinois, 60118

United States

Dawes Fretzin Clinical Research Group

Columbus, Indiana, 47201

United States

The South Bend Clinic

South Bend, Indiana, 46617

United States

Equity Medical - Bowling Green

Bowling Green, Kentucky, 42104

United States

Velocity Clinical Research at The Dermatology Clinic, Baton Rouge

Baton Rouge, Louisiana, 70808

United States

Tulane University School of Medicine

New Orleans, Louisiana, 70112

United States

MetroBoston Clinical Partners

Brighton, Massachusetts, 02135

United States

Great Lakes Research Group Inc.

Bay City, Michigan, 48706

United States

Cleaver Dermatology

Kirksville, Missouri, 63501-5362

United States

OptiSkin

New York, New York, 10128-0724

United States

Duke University School of Medicine

Durham, North Carolina, 27713

United States

The Skin Surgery Center for Clinical Research

Winston-Salem, North Carolina, 27103

United States

The Ohio State University Wexner Medical Center (OSUWMC) - OSU Dermatology East - Columbus

Gahanna, Ohio, 43230-5317

United States

Dermatologists of Southwestern Ohio, LLC

Mason, Ohio, 45040-4520

United States

Unity Clinical Research (UCR)

Oklahoma City, Oklahoma, 73118

United States

Velocity Clinical Research, Medford

Medford, Oregon, 97504

United States

Oregon Medical Research Center

Portland, Oregon, 97201

United States

Paddington Testing Company Inc.

Philadelphia, Pennsylvania, 19103

United States

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213

United States

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407

United States

Coastal Carolina Research Center (CCRC) - North Charleston

North Charleston, South Carolina, 29405

United States

Health Concepts

Rapid City, South Dakota, 57702-9208

United States

Discover Dermatology, LLC d/b/a Goodlettsville Dermatology Research

Goodlettsville, Tennessee, 37072-2301

United States

Discover Dermatology, LLC d/b/a Cumberland Skin Center for Clinical Research under Objective Health

Hermitage, Tennessee, 37076

United States

UT Health Houston Department of Dermatology

Bellaire, Texas, 77401

United States

Studies in Dermatology, LLC

Cypress, Texas, 77429

United States

Reveal Research Institute

Frisco, Texas, 75033

United States

Center for Clinical Studies - Texas Medical Center

Houston, Texas, 77004

United States

Heights Dermatology & Aesthetic Center

Houston, Texas, 77008

United States

Austin Institute for Clinical Research - Houston

Houston, Texas, 77056

United States

Stride Clinical Research LLC

Sugar Land, Texas, 77479

United States

University of Utah Health Care - Midvalley Health Center

Murray, Utah, 84107

United States

Frontier Dermatology

Mill Creek, Washington, 98012

United States

Collaborators and Investigators

Sponsor: Alumis Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-25

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-07-25

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Plaque Psoriasis