A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001
NCT ID: NCT06588738
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
840 participants
INTERVENTIONAL
2024-08-20
2025-12-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ESK-001
ESK-001 administered as an oral tablet
ESK-001
ESK-001
Placebo
Matching oral placebo
Placebo
Placebo
Apremilast
Apremilast administered as an oral capsule
Apremilast
Apremilast
Interventions
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ESK-001
ESK-001
Placebo
Placebo
Apremilast
Apremilast
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Alumis Inc
INDUSTRY
Responsible Party
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Locations
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Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
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
Revival Research Institute
Troy, Michigan, United States
Grekin Skin Institute
Warren, Michigan, United States
Associated Skin Care Specialists - Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Schlessinger MD
Omaha, Nebraska, United States
Las Vegas Clinical Trials
Las Vegas, Nevada, United States
NYC Health and Hospitals Elmhurst
Elmhurst, New York, United States
Pioneer Clinical Research NY
New York, New York, United States
Cameron Dermatology
New York, New York, United States
DermResearchCenter of New York
Stony Brook, New York, United States
Asheville Clinical Trials
Asheville, North Carolina, United States
WDC Cosmetic and Research
Wilmington, North Carolina, United States
Optima Research Boardman
Boardman, Ohio, United States
Clinical Partners LLC
Johnston, Rhode Island, United States
Modern Research Associates PLLC
Dallas, Texas, United States
SMS Clinical Research
Mesquite, Texas, United States
Progressive Clinical Research - San Antonio
San Antonio, Texas, United States
Center for Clinical Studies (CCS) - Webster/Clear Lake Location
Webster, Texas, United States
Jordan Valley Dermatology
South Jordan, Utah, United States
Klinik Hietzing
Vienna, Vienna, Austria
Beacon Dermatology
Calgary, Alberta, Canada
Alberta DermaSurgery
Edmonton, Alberta, Canada
VIDA Dermatology/VIDA Clinical Research
Edmonton, Alberta, Canada
CaRe Clinic Red Deer
Red Deer, Alberta, Canada
Skincare Studio
St. John's, Newfoundland and Labrador, Canada
CCA Medical Research Corp
Ajax, Ontario, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada
SKiN Health
Cobourg, Ontario, Canada
Kingsway Clinical Research
Etobicoke, Ontario, Canada
Guelph Dermatology Research
Guelph, Ontario, Canada
Mediprobe Research
London, Ontario, Canada
Clear Skin Dermatology
Newmarket, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
Rejuvination Dermatology Oakville
Oakville, Ontario, Canada
Toronto Research Centre
Toronto, Ontario, Canada
XLR8 Medical Research
Windsor, Ontario, Canada
Innovaderm
Montreal, Quebec, Canada
SkinSense Medical Research
Saskatoon, Saskatchewan, Canada
Innomedica
Tallinn, Harju, Estonia
Tartu University Hospital
Tartu, Tartu, Estonia
Center for Clinical and Basic Research AS
Tallinn, , Estonia
Kliiniliste Uuringute Keskus OU
Tartu, , Estonia
CHU de Rouen
Rouen, Normandy, France
Centre Azur Nice
Nice, , France
Polyclinique de Courlancy
Reims, , France
Universitatsklinikum Erlangen
Erlangen, Bavaria, Germany
Rosenpark Research
Darmstadt, Hesse, Germany
Klinikum Oldenburg
Oldenburg, Lower Saxony, Germany
Klinische Forschung Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, Germany
Hautarztpraxis Dr Niesmann and Dr Othlinghaus
Bochum, North Rhine-Westphalia, Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, Germany
Dermatologische Praxis Dres Quist
Mainz, Rhinelkand-Palatinate, Germany
Praxis fur Dermatologie und Venerologie
Dresden, Saxony, Germany
Klinische Forschung Dresden GmbH
Dresden, Saxony, Germany
ISA - Interdisciplinary Study Association GmbH
Berlin, State of Berlin, Germany
MVZ DermaKiel GmbH
Kiel, , Germany
Haut Ambulatorium Magdeburg
Magdeburg, , Germany
KliFOs Klinische Forschung Osnabruck
Osnabrück, , Germany
Bacs Kiskun County Teaching Hospital
Kecskemét, Bács-Kiskun county, Hungary
Borgyogyaszati Klinika Debreceni Egyetem Orvos es Egeszsegtudomenyi Centrum
Debrecen, Hajdú-Bihar, Hungary
DERMA B Kft
Debrecen, Hajdú-Bihar Megye, Hungary
DermaMed Research Kf
Békés, Oroshaza, Hungary
Uno Medical Trials Kft
Budapest, , Hungary
Orvostudomanyi Kutato es Fejleszto Kft
Debrecen, , Hungary
Allergo Derm Bakos Kft
Szolnok, , Hungary
Medmare Bt
Veszprém, , Hungary
Sheba Tel HaShomer Medical Centre
Ramat Gan, , Israel
Semigallia Ltd
Kuldīga, Kuldigas, Latvia
Smite Aija Medical Practice in Dermatology Venereology
Talsi, Talsi, Latvia
Riga 1st Hospital
Riga, , Latvia
Med Art Clinic
Riga, , Latvia
Veselibas Centrs 4
Riga, , Latvia
SIA Veseliba un estetika
Riga, , Latvia
Veselibas Centrs 4 Filiale Dermatologijas Klinika
Riga, , Latvia
FutureMeds Krakow
Krakow, Lesser Poland Voivodeship, Poland
Luxderm
Lublin, Lublin Voivodeship, Poland
Centrum Medyczne dr Rajzer Spolka Zoo
Krakow, Malopolska, Poland
RCMed Oddział Sochaczew
Sochaczew, Masovian Voivodeship, Poland
Clinical Best Solutions
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, Poland
Klinika Dermatologii Uniwersytecki Szpital Kliniczny im F Chopina
Rzeszów, Podkarpackie Voivodeship, Poland
Specderm
Bialystok, Podlaskie Voivodeship, Poland
Pratia Gdynia
Gdynia, Pomeranian Voivodeship, Poland
Pratia Katowice
Katowice, Silesian Voivodeship, Poland
Research Solutions
Katowice, Silesian Voivodeship, Poland
Care Clinic Katowice
Katowice, , Poland
Zanamed Medical Clinic Sp z o o
Lublin, , Poland
MTZ Clinical Research Sp z o o
Warsaw, , Poland
Klinika Ambroziak Dermatologia Kliniczna
Warsaw, , Poland
dermMedica
Wroclaw, , Poland
Dermoklinika
Lodz, Łódź Voivodeship, Poland
FutureMeds Lodz
Lodz, Łódź Voivodeship, Poland
GCM Medical Group PSC Hato Rey Site
San Juan, PR, Puerto Rico
Centro Reumatologico de Caguas
Caguas, Puerto Rico, Puerto Rico
Ponce Medical School Foundation Inc
Ponce, Puerto Rico, Puerto Rico
Clinical Research Puerto Rico
Ponce, Puerto Rico, Puerto Rico
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
University General Hospital Dr Balmis
Alicante, Alicante, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital de Manises
Manises, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Countries
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Other Identifiers
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ESK-001-017
Identifier Type: -
Identifier Source: org_study_id