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

Purpose

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.

Condition

  • Plaque Psoriasis

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion 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

Exclusion Criteria

  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 * Stable doses of inhaled corticosteroids for treatment of asthma are allowed 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ESK-001 		ESK-001 administered as an oral tablet
  • Drug: ESK-001
    ESK-001
Placebo Comparator
Placebo 		Matching oral placebo
  • Drug: Placebo
    Placebo
Active Comparator
Apremilast 		Apremilast administered as an oral capsule
  • Drug: Apremilast
    Apremilast

Recruiting Locations

Alliance Dermatology
Phoenix, Arizona 85032

Scottsdale Clinical Trials
Scottsdale, Arizona 85260

Northwest Arkansas Clinical Trials Center (NWACTC), PLLC
Rogers, Arkansas 72758-8600

Exalt Clinical Research
Chula Vista, California 91910

California Dermatology & Clinical Research Institute
Encinitas, California 92024-7700

First OC Dermatology Research Inc
Fountain Valley, California 92708

Marvel Clinical Research, LLC
Huntington Beach, California 92647

Sunwise Clinical Research, LLC
Lafayette, California 94549

Wallace Medical Group Inc
Los Angeles, California 90056

Northridge Clinical Trials - Elite Clinical Network
Northridge, California 91325

Pasadena Clinical Trials
Pasadena, California 91101

Therapeutics Clinical Research
San Diego, California 92123

Unison Clinical Trials/ Shahram Jacobs MD
Sherman Oaks, California 91403-1814

Olive View - UCLA Education & Research Institute
Sylmar, California 91342

California Dermatology Institute - Thousand Oaks
Thousand Oaks, California 91320-2130

Clearlyderm Dermatology - West Boca Raton
Boca Raton, Florida 33428

Driven Clinical Research
Coral Gables, Florida 33134

Jacksonville Center for Clinical Research
Jacksonville, Florida 32216

Accel Research Sites - Maitland
Maitland, Florida 32751

Glick Skin Institute - Margate
Margate, Florida 33063-7011

San Marcus Research Clinic, Inc - Miami
Miami Lakes, Florida 33014

Savin Medical Group LLC
Miami Lakes, Florida 33014

Oceanic Research Group
North Miami Beach, Florida 33169

LENUS Research
Sweetwater, Florida 33172

Caban Skin Institute
Tampa, Florida 33607

ForCare Medical Center
Tampa, Florida 33613-1244

Skin Care Physicians of Georgia - Warner Robins
Macon, Georgia 31217

Velocity Clinical Research, Boise
Meridian, Idaho 83642

MetroMed Clinical Trials
Chicago, Illinois 60614-3625

Arlington Dermatology
Rolling Meadows, Illinois 60008

NorthShore Medical Group - Dermatology - Skokie
Skokie, Illinois 60077-1049

Dundee Dermatology
West Dundee, Illinois 60118

Dawes Fretzin Clinical Research Group
Columbus, Indiana 47201

The South Bend Clinic
South Bend, Indiana 46617

Equity Medical - Bowling Green
Bowling Green, Kentucky 42104

Velocity Clinical Research at The Dermatology Clinic, Baton Rouge
Baton Rouge, Louisiana 70808

MetroBoston Clinical Partners
Brighton, Massachusetts 02135

Great Lakes Research Group Inc.
Bay City, Michigan 48706

Cleaver Dermatology
Kirksville, Missouri 63501-5362

OptiSkin
New York, New York 10128-0724

Duke University School of Medicine
Durham, North Carolina 27713

The Skin Surgery Center for Clinical Research
Winston-Salem, North Carolina 27103

The Ohio State University Wexner Medical Center (OSUWMC) - OSU Dermatology East - Columbus
Gahanna, Ohio 43230-5317

Dermatologists of Southwestern Ohio, LLC
Mason, Ohio 45040-4520

Unity Clinical Research (UCR)
Oklahoma City, Oklahoma 73118

Velocity Clinical Research, Medford
Medford, Oregon 97504

Oregon Medical Research Center
Portland, Oregon 97201

Paddington Testing Company Inc.
Philadelphia, Pennsylvania 19103

UPMC Department of Dermatology
Pittsburgh, Pennsylvania 15213

Clinical Research Center of the Carolinas
Charleston, South Carolina 29407

Coastal Carolina Research Center (CCRC) - North Charleston
North Charleston, South Carolina 29405

Health Concepts
Rapid City, South Dakota 57702-9208

Discover Dermatology, LLC d/b/a Goodlettsville Dermatology Research
Goodlettsville, Tennessee 37072-2301

Discover Dermatology, LLC d/b/a Cumberland Skin Center for Clinical Research under Objective Health
Hermitage, Tennessee 37076

Studies in Dermatology, LLC
Cypress, Texas 77429

Reveal Research Institute
Frisco, Texas 75033

Center for Clinical Studies - Texas Medical Center
Houston, Texas 77004

Heights Dermatology & Aesthetic Center
Houston, Texas 77008

Austin Institute for Clinical Research - Houston
Houston, Texas 77056

Stride Clinical Research LLC
Sugar Land, Texas 77479

University of Utah Health Care - Midvalley Health Center
Murray, Utah 84107

Frontier Dermatology
Mill Creek, Washington 98012

More Details

NCT ID
NCT06586112
Status
Recruiting
Sponsor
Alumis Inc

Study Contact

Alumis Information
(650) 231-6625
clinicaltrials@alumis.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center