A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis
NCT ID: NCT06586112
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
2024-07-25
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
Apremilast
Apremilast
Placebo
Placebo
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). 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
18 Years
ALL
No
Sponsors
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Alumis Inc
INDUSTRY
Responsible Party
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Locations
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Alliance Dermatology
Phoenix, Arizona, United States
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
Skin Care Physicians of Georgia - Warner Robins
Macon, Georgia, United States
Velocity Clinical Research, Boise
Meridian, Idaho, United States
MetroMed Clinical Trials
Chicago, Illinois, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
NorthShore Medical Group - Dermatology - Skokie
Skokie, Illinois, United States
Dundee Dermatology
West Dundee, Illinois, United States
Dawes Fretzin Clinical Research Group
Columbus, Indiana, United States
The South Bend Clinic
South Bend, Indiana, United States
Equity Medical - Bowling Green
Bowling Green, Kentucky, United States
Velocity Clinical Research at The Dermatology Clinic, Baton Rouge
Baton Rouge, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
MetroBoston Clinical Partners
Brighton, Massachusetts, United States
Cleaver Dermatology
Kirksville, Missouri, United States
OptiSkin
New York, New York, United States
The Ohio State University Wexner Medical Center (OSUWMC) - OSU Dermatology East - Columbus
Gahanna, Ohio, United States
Dermatologists of Southwestern Ohio, LLC
Mason, Ohio, United States
Unity Clinical Research (UCR)
Oklahoma City, Oklahoma, United States
Velocity Clinical Research, Medford
Medford, Oregon, United States
Oregon Medical Research Center
Portland, Oregon, United States
Paddington Testing Company Inc.
Philadelphia, Pennsylvania, United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, United States
Health Concepts
Rapid City, South Dakota, United States
Discover Dermatology, LLC d/b/a Goodlettsville Dermatology Research
Goodlettsville, Tennessee, United States
Discover Dermatology, LLC d/b/a Cumberland Skin Center for Clinical Research under Objective Health
Hermitage, Tennessee, United States
UT Health Houston Department of Dermatology
Bellaire, Texas, United States
Studies in Dermatology, LLC
Cypress, Texas, United States
Reveal Research Institute
Frisco, Texas, United States
Center for Clinical Studies - Texas Medical Center
Houston, Texas, United States
Austin Institute for Clinical Research - Houston
Houston, Texas, United States
University of Utah Health Care - Midvalley Health Center
Murray, Utah, United States
Frontier Dermatology
Mill Creek, Washington, United States
Premier Specialists
Kogarah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
North Eastern Health Specialists (NEHS)
Campbelltown, South Australia, Australia
Skin Health Institute Inc.
Carlton, Victoria, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Multiprofile Hospital for Active Treatment Dr Tota Venkova
Gabrovo, Gabrovo, Bulgaria
Clineca
Stara Zagora, Stara Zagora, Bulgaria
Medikal Center Kordis
Pleven, , Bulgaria
Skin and Venereal Diseases Center EOOD
Sofia, , Bulgaria
Diagnostic Consultative Center Aleksandrovska EOOD
Sofia, , Bulgaria
Rejuvenation Medical Group Edmonton Downtown
Edmonton, Alberta, Canada
Enverus Medical Research
Surrey, British Columbia, Canada
Dermatrials Research Inc.
Hamilton, Ontario, Canada
Centricity Research
London, Ontario, Canada
DermEffects
London, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
Institute of Cosmetic & Laser Surgery
Oakville, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
North York Research Inc.
Toronto, Ontario, Canada
Canadian Dermatology Centre
Toronto, Ontario, Canada
Dermatology on Bloor
Toronto, Ontario, Canada
Alliance Clinical Trials
Waterloo, Ontario, Canada
"Centre de Recherche Dermatologique du Quebec Metropolitain Inc."
Québec, Quebec, Canada
Dermatologie Sima Inc.
Verdun, Quebec, Canada
Fakultni nemocnice Plzen Dermatovenerologicka klinika
Pilsen, Bory, Czechia
Pratia Brno s.r.o.
Brno, Moravia, Czechia
Dermskin, s.r.o.
Olomouc, Moravia, Czechia
Kozni ambulance Kutna Hora, s.r.o.
Kutná Hora, , Czechia
DERMAMEDICA, s.r.o.
Náchod, , Czechia
Nemocnice Nový Jičín, A.S.
Nový Jičín, , Czechia
CCR Ostrava, s.r.o.
Ostrava, , Czechia
Vesalion sro
Ostrava, , Czechia
Pratia Pardubice a.s.
Pardubice, , Czechia
Clintrial s.r.o.
Prague, , Czechia
Fakultni Nemocnice Kralovske Vinohrady FNKV Dermatovenerologicka Klinika
Prague, , Czechia
Sanatorium Profesora Arenbergera
Prague, , Czechia
Pratia Prague, s.r.o.
Prague, , Czechia
Praglandia
Prague, , Czechia
Dermatologicka ambulance - Svitavy
Svitavy, , Czechia
MUDr Radka Neumannova
Svitavy, , Czechia
Eberhard Karls Universitaet Tuebingen Universitaets Hautklinik Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Hautarztpraxis Dr. Mihaescu
Augsburg, Bavaria, Germany
Hautarztpraxis Mahlow
Mahlow, Brandenburg, Germany
Universitatsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, Germany
Hautarztpraxis an der Hase
Bramsche, Lower Saxony, Germany
Siteworks
Lohne, Lower Saxony, Germany
Klinikum Bielefeld
Bielefeld, North Rhine-Westphalia, Germany
Pro Derma
Dülmen, North Rhine-Westphalia, Germany
Intramedis CSS
Remscheid, North Rhine-Westphalia, Germany
Universitatsklinikum Carl Gustav Carus an der Technischen Universitat Dresden
Dresden, Saxony, Germany
Universitatsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
Fukuoka University Hospital
Fukuoka, Fukuoka-shi, Japan
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan
Nihon University Itabashi Hospital
Tokyo, Itabashi-Ku, Japan
Saruwatari Dermatology Clinic
Kagoshima, Kagoshima-Shi, Japan
Kanto Rosai Hospital
Kanagawa, Kawasaki-shi, Japan
Nagoya City University Hospital
Aichi, Nagoya-shi, Japan
Okayama University Hospital
Okayama, Okayama-shi, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka-shi, Japan
Nippon Life Hospital
Osaka, Osaka-Shi, Japan
National Hospital Organization Sagamihara National Hospital
Kanagawa, Sagamihara, Japan
Dermatology and Ophthalmology Kume Clinic
Osaka, Saka-Shi, Japan
Hokkaido University Hospital
Hokkaido, Sapporo-shi, Japan
Kindai University Hospital
Osaka, Sayama-Shi, Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-Ku, Japan
Osaka University Hospital
Osaka, Suita-shi, Japan
Medical Corporation Jitai kai Tachikawa Dermatology Clinic
Tokyo, Tachikawa-shi, Japan
Mie University Hospital
Mie, Tsu-shi, Japan
Yamaguchi University Hospital
Yamaguchi, Ube-shi, Japan
Yokohama City University Hospital
Kanagawa, Yokohama-shi, Japan
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Specjalistyczny Ośrodek Alergologiczno-Internistyczny "ALL-MED"
Krakow, Lesser Poland Voivodeship, Poland
Centrum Medyczne Synexus Wroclaw
Wroclaw, Lower Silesian Voivodeship, Poland
WroMedica
Wroclaw, Lower Silesian Voivodeship, Poland
Diamond Clinic
Krakow, Malopolska, Poland
MICS Medical Center Warsaw
Warsaw, Masovian Voivodeship, Poland
FutureMeds Warszawa Centrum
Warsaw, Masovian Voivodeship, Poland
High Med Przychodnia Specjalistyczna
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Reuma Park
Warsaw, Masovian Voivodeship, Poland
RoyalDerm
Warsaw, Mazowiecke, Poland
ClinicMed Daniluk, Nowak Spolka Komandytowa
Bialystok, Podlaskie Voivodeship, Poland
AES Gdansk
Gdansk, Pomeranian Voivodeship, Poland
Derm Art Institute
Gdynia, Pomeranian Voivodeship, Poland
Centrum Medyczne Synexus Gdynia
Gdynia, Pomeranian Voivodeship, Poland
Centrum Medyczne Angelius Provita (Angelius Provita Medical Centre)
Katowice, Silesian Voivodeship, Poland
Laser Clinic
Szczecin, West Pomeranian Voivodeship, Poland
Centrum Badań Klinicznych PI House Sp. Z O.O.
Gdansk, , Poland
Pratia Małopolskie Centrum Medyczne (MCM) Kraków
Krakow, , Poland
Rheuma Medicus
Warsaw, , Poland
Centrum Medyczne Synexus Warszawa
Warsaw, , Poland
Velocity Clinical Research, Skierniewice
Skierniewice, Łódź Voivodeship, Poland
Hospital da Senhora da Oliveira
Guimarães, Braga District, Portugal
Hospital CUF Descobertas
Lisbon, Lisbon District, Portugal
Unidade Local de Saude Santo Antonio Hospital de Santo Antonio
Porto, Porto District, Portugal
Chosun Universtiy Hospital
Gwangju, Dong-gu, South Korea
Konkuk University Medical Center
Seoul, Gwangjin-gu, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Pusan National University Hospital
Busan, , South Korea
Kyung Hee University Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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ESK-001-016
Identifier Type: -
Identifier Source: org_study_id