A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis
- Registration Number
- NCT06586112
- Lead Sponsor
- Alumis Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 840
- Males or females, age ≥18 years
- Diagnosis of plaque psoriasis for ≥6 months
- Plaques covering ≥10% of BSA
- PASI ≥12
- sPGA ≥3
- Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception
-
Nonplaque psoriasis or other inflammatory skin conditions
-
immune-mediated conditions commonly associated with psoriasis (eg inflammatory bowel disease). Participants with psoriatic arthritis may participate
-
Pregnant, lactating, or planning to get pregnant during the study
-
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
-
Lack of clinical response to a TYK2, IL-12, or IL-23 targeted psoriasis treatment
-
Participants with QTcF >450 msec (males) or >470 msec (females) at Screening
-
Unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months
-
Evidence of recent or recurrent herpes zoster or herpes simplex viral infection
-
Evidence of active infection or positive test result for hepatitis B, hepatitis C, HIV or TB
-
History of serious bacterial, fungal, or viral infections that led to hospitalization, or any recent serious infection requiring antibiotic treatment
-
Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
-
Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
-
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
-
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
-
Live vaccines within 4 weeks prior to Study Day 1
-
Participant has planned surgery during the study period
-
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
-
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
-
Evidence of severe depressive symptoms or active suicidal ideation or behavior
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ESK-001 ESK-001 ESK-001 administered as an oral tablet Placebo Placebo Matching oral placebo Apremilast Apremilast Apremilast administered as an oral capsule
- Primary Outcome Measures
Name Time Method To determine whether ESK-001 reduces the severity of psoriasis by 75% (using the PASI) or by at least 2 points (using sPGA score) compared to placebo 16 weeks Proportion of participants achieving ≥75% reduction in PASI score. Proportion of participants achieving a score of 0 or 1 on sPGA.
- Secondary Outcome Measures
Name Time Method To compare the Psoriasis Area and Severity Index (PASI-90 and PASI-100) between ESK-001 and placebo or apremilast 24 weeks Proportion of participants achieving of ≥90% or 100% reduction in PASI
To compare the Psoriasis Area and Severity Index (PASI-75) between ESK-001 and apremilast 24 weeks Proportion of participants achieving of ≥75% reduction in PASI
To compare the Static Physician's Global Assessment (sPGA-0/1) between ESK-001 and apremilast 24 weeks Proportion of participants achieving a score of 0 or 1 on sPGA
To compare the affected body surface area (%BSA) between ESK-001 and placebo or apremilast 24 weeks Change from baseline in %BSA
To compare the scalp specific Physician's Global Assessment (ssPGA) between ESK-001 and placebo or apremilast. 24 weeks Proportion of participants achieving a score of 0 or 1 on ssPGA
To compare the Psoriasis Symptoms and Signs Diary (PSSD) between ESK-001 and placebo or apremilast 24 weeks Proportion of participants achieving a score of 0
To compare the Dermatology Life Quality Index (DLQI) between ESK-001 and placebo or apremilast 24 weeks Proportion of participants achieving a score of 0 or 1
To compare the Pruritus numeric rating scale (NRS) between ESK-001 and placebo 24 weeks Change from baseline in Pruritus NRS
Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) 24 weeks Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
To characterize the pharmacokinetics of ESK-001 24 weeks Maximum \[Cmax\] and minimum \[Cmin\] plasma concentration
Trial Locations
- Locations (183)
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
Accel Research Sites - Maitland
🇺🇸Maitland, 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
Great Lakes Research Group Inc.
🇺🇸Bay City, Michigan, United States
Cleaver Dermatology
🇺🇸Kirksville, Missouri, United States
OptiSkin
🇺🇸New York, New York, United States
Duke University School of Medicine
🇺🇸Durham, North Carolina, United States
The Skin Surgery Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, 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
Clinical Research Center of the Carolinas
🇺🇸Charleston, South Carolina, United States
Coastal Carolina Research Center (CCRC) - North Charleston
🇺🇸North Charleston, South Carolina, 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
Heights Dermatology & Aesthetic Center
🇺🇸Houston, Texas, United States
Austin Institute for Clinical Research - Houston
🇺🇸Houston, Texas, United States
Stride Clinical Research LLC
🇺🇸Sugar Land, 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
Veracity Clinical Research
🇦🇺Woolloongabba, Queensland, Australia
North Eastern Health Specialists (NEHS)
🇦🇺Campbelltown, South Australia, Australia
DermEdge Research
🇨🇦Mississauga, Ontario, Canada
Skin Health Institute Inc.
🇦🇺Carlton, Victoria, Australia
Sinclair Dermatology
🇦🇺East Melbourne, Victoria, Australia
C H U de Liege
🇧🇪Liège, Liege, Belgium
Multiprofile Hospital for Active Treatment Dr Tota Venkova
🇧🇬Gabrovo, Bulgaria
Medikal Center Kordis
🇧🇬Pleven, Bulgaria
Skin and Venereal Diseases Center EOOD
🇧🇬Sofia, Bulgaria
Diagnostic Consultative Center Aleksandrovska EOOD
🇧🇬Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Alexandrovska
🇧🇬Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
🇧🇬Sofia, Bulgaria
Clineca
🇧🇬Stara Zagora, 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
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
🇨🇿Plzen, Bory, Czechia
Pratia Brno s.r.o.
🇨🇿Brno, Moravia, Czechia
Dermskin, s.r.o.
🇨🇿Olomouc, Moravia, Czechia
Kozni ambulance Kutna Hora, s.r.o.
🇨🇿Kutna Hora, Czechia
DERMAMEDICA, s.r.o.
🇨🇿Nachod, 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
🇩🇪Tuebingen, Baden-Württemberg, Germany
Hautarztpraxis Dr. Mihaescu
🇩🇪Augsburg, Bayern, Germany
emovis GmbH
🇩🇪Berlin, Brandenburg, Germany
Hautarztpraxis Mahlow
🇩🇪Mahlow, Brandenburg, Germany
Klinikum Darmstadt GmbH - Hautklinik
🇩🇪Darmstadt, Hessen, Germany
Universitatsklinikum Frankfurt
🇩🇪Frankfurt, Hessen, Germany
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, Lower Saxony, Germany
Hautarztpraxis an der Hase
🇩🇪Bramsche, Lower Saxony, Germany
Siteworks
🇩🇪Lohne, Lower Saxony, Germany
Universitätsklinikum Köln
🇩🇪Cologne, North Rhine-Westphalia, Germany
Klinikum Bielefeld
🇩🇪Bielefeld, NRW, Germany
Universitatsklinikum Bonn
🇩🇪Bonn, NRW, Germany
Pro Derma
🇩🇪Dülmen, NRW, Germany
Intramedis CSS
🇩🇪Remscheid, NRW, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Clinical Research Center CRC
🇩🇪Mainz, Rhineland-Palatinate, Germany
Universitatsklinikum Carl Gustav Carus an der Technischen Universitat Dresden
🇩🇪Dresden, Saxonia, Germany
Universitatsklinikum Schleswig-Holstein
🇩🇪Kiel, Schleswig-Holstein, Germany
Charite Universitaetsmedizin Berlin Campus Virchow Klinikum CVK
🇩🇪Berlin, 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
Yamanashi Prefectural Central Hospital
🇯🇵Yamanashi, Kofu-shi, Japan
Nagoya City University Hospital
🇯🇵Aichi, Nagoya-shi, Japan
Okayama University Hospital
🇯🇵Okayama, Okayama-shi, Japan
Seoul St Marys Hospital
🇰🇷Seoul, Korea, Republic of
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
Tohoku University Hospital
🇯🇵Miyagi, Sendai-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
Chosun Universtiy Hospital
🇰🇷Gwangju, Dong-gu, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Gwangjin-gu, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang-si, Gyeonggi-do, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Songpa-gu, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kyung Hee University Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Centrum Medyczne Synexus Wroclaw
🇵🇱Wroclaw, Dolnoslaskie, Poland
Centrum Medyczne Pratia Bydgoszcz
🇵🇱Bydgoszcz, Kujawsko-Pomorskie, Poland
Velocity Clinical Research, Skierniewice
🇵🇱Skierniewice, Lodzkie, Poland
WroMedica
🇵🇱Wroclaw, Lower Silesia, Poland
Diamond Clinic
🇵🇱Krakow, Malopolska, Poland
MICS Medical Center Warsaw
🇵🇱Warsaw, Mazovia, Poland
FutureMeds Warszawa Centrum
🇵🇱Warsaw, Mazovia, Poland
High Med Przychodnia Specjalistyczna
🇵🇱Warsaw, Mazovia, Poland
Centrum Medyczne Reuma Park
🇵🇱Warsaw, Mazovia, Poland
RoyalDerm
🇵🇱Warsaw, Mazowiecke, Poland
Specjalistyczny Ośrodek Alergologiczno-Internistyczny "ALL-MED"
🇵🇱Krakow, MA, Poland
ClinicMed Daniluk, Nowak Spolka Komandytowa
🇵🇱Bialystok, Podlaskie, Poland
AES Gdansk
🇵🇱Gdansk, Pomorskie, Poland
Derm Art Institute
🇵🇱Gdynia, Pomorskie, Poland
Centrum Medyczne Synexus Gdynia
🇵🇱Gdynia, Pomorskie, Poland
Centrum Medyczne Angelius Provita (Angelius Provita Medical Centre)
🇵🇱Katowice, Silesia, Poland
Laser Clinic
🇵🇱Szczecin, Zachodniopomorskie, Poland
Centrum Badań Klinicznych PI House Sp. Z O.O.
🇵🇱Gdańsk, Poland
Pratia Małopolskie Centrum Medyczne (MCM) Kraków
🇵🇱Krakow, Poland
Rheuma Medicus
🇵🇱Warsaw, Poland
Centrum Medyczne Synexus Warszawa
🇵🇱Warsaw, Poland
Hospital da Senhora da Oliveira
🇵🇹Guimaraes, Braga, Portugal
Unidade Local de Saude Braga
🇵🇹Braga, Portugal
Hospital CUF Descobertas
🇵🇹Lisbon, Portugal
Unidade Local de Saude Santo Antonio Hospital de Santo Antonio
🇵🇹Porto, Portugal