Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
NCT ID: NCT06846541
Last Updated: 2025-10-28
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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RECRUITING
PHASE3
1680 participants
INTERVENTIONAL
2025-01-08
2028-11-30
Brief Summary
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* How safe is taking ESK-001 long-term in people with moderate to severe plaque psoriasis?
* Does taking ESK-001 long-term reduce the severity of people's plaque psoriasis?
Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks. After 24 weeks, the first 200 patients meeting at least PASI-75 clinical response will be randomly assigned to receive ESK-001 or placebo. At any point during this time, the patients losing the initial clinical response may return to the open-label ESK-001 treatment. Patients who complete Week 48 will return to open-label ESK-001 treatment and they will receive ESK-001 until the end of the study or discontinuation. All the remaining patients not meeting the entry criteria for the randomized withdrawal phase will continue to receive open-label ESK-001 for the remainder of the study.
Patients taking part in the study must be men or women aged at least 18 years old and have completed a previous (parent) study of ESK-001 in moderate to severe plaque psoriasis.
Patients must consent and agree to:
* ensure drug daily compliance until end of study or discontinuation.
* visit the clinic for checkups and assessments.
* provide blood and urine samples.
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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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Open-Label ESK-001
Open-Label ESK-001 administered as an oral tablet
Open-Label ESK-001
Open-Label ESK-001
Blinded ESK-001
Blinded ESK-001 administered as an oral tablet
Blinded ESK-001
Blinded ESK-001 during Randomized Treatment Withdrawal Period
Placebo
Matching placebo administered as an oral tablet
Placebo
Placebo during Randomized Treatment Withdrawal Period
Interventions
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Open-Label ESK-001
Open-Label ESK-001
Blinded ESK-001
Blinded ESK-001 during Randomized Treatment Withdrawal Period
Placebo
Placebo during Randomized Treatment Withdrawal Period
Eligibility Criteria
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Inclusion Criteria
2. Completed either of the two previous (parent) studies of ESK-001 (ESK-001-016 or ESK-001-017)
3. ESK-001 safety and tolerability were acceptable in the parent study
4. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception for the entirety of the study
Exclusion Criteria
2. Any acute or chronic illness/condition or evidence of an unstable clinical condition that in the Investigator's judgment will substantially increase the risk to the patient if they continue to receive ESK-001 treatment in this extension study
3. Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol
18 Years
ALL
No
Sponsors
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Alumis Inc
INDUSTRY
Responsible Party
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Locations
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Pheonix, Arizona, United States
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Noble Clinical Research
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Northwest AR Clinical Trials Center PLLC
Rogers, Arkansas, United States
Zenith Research Inc.
Beverly Hills, California, United States
Exalt Clinical Research Inc
Chula Vista, California, United States
California Dermatology and Clinical Research Institute
Encinitas, California, United States
Raoof MD
Encino, California, United States
First OC Dermatology Research Inc
Fountain Valley, California, United States
Marvel Clinical Research LLC
Huntington Beach, California, United States
Long Beach Research Institute
Long Beach, California, United States
Olive View UCLA Education and Research Institute
Los Angeles, California, United States
Dermatology Research Associates
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Wallace Medical Group Inc
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Northridge Clinical Trials
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Pasadena Clinical Trials
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Empire Clinical Research Pomona
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Integrative Skin Science and Research
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Southern California Clinical Research
Santa Ana, California, United States
Clinical Science Institute Dermatology Institute
Santa Monica, California, United States
Unison Clinical Trials
Sherman Oaks, California, United States
California Dermatology Institute Thousand Oaks
Thousand Oaks, California, United States
Sunwise Clinical Research LLC
Walnut Creek, California, United States
Clearlyderm Dermatology West Boca Raton
Boca Raton, Florida, United States
Driven Clinical Research
Coral Gables, Florida, United States
FXM Clinical Research Ft. Lauderdale LLC
Fort Lauderdale, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Glick Skin Institute
Margate, Florida, United States
AppleMed Research Group
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
Procare Research Center
Miami Gardens, Florida, United States
San Marcus Research Clinic Inc - Miami
Miami Lakes, Florida, United States
Savin Medical Group LLC
Miami Lakes, Florida, United States
FXM Clinical Research Miramar LLC
Miramar, Florida, United States
Oceanic Research Group
North Miami Beach, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Lenus Research and Medical Group LLC
Sweetwater, Florida, United States
Advanced Clinical Research Institute
Tampa, Florida, United States
ForCare Medical Center
Tampa, Florida, 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
DS Research of Southern Indiana
Clarksville, Indiana, United States
Dawes Fretzin Clinical Research Group
Columbus, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
The South Bend Clinic
South Bend, Indiana, United States
Equity Medical
Bowling Green, Kentucky, United States
DS Research of Kentucky
Louisville, Kentucky, United States
Velocity Clinical Research
Baton Rouge, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
MetroBoston Clinical Partners
Brighton, Massachusetts, United States
Michigan Center for Research Company
Clarkston, Michigan, United States
Henry Ford Medical Center Farmington
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
Cleaver Dermatology
Kirksville, Missouri, 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
OptiSkin
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
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, 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 Partners LLC
Johnston, Rhode Island, United States
Studies in Dermatology LLC
Cypress, Texas, United States
Modern Research Associates PLLC
Dallas, 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, 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
University of Utah Health Care Midvalley Health Center
Murray, Utah, United States
Jordan Valley Dermatology
South Jordan, Utah, United States
Frontier Dermatology
Mill Creek, Washington, United States
Premier Specialist
Kogarah, New South Wales, Australia
North Eastern Health Specialists
Campbelltown, South Australia, Australia
Skin Health Institute
Carlton, Victoria, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Multiprofile Hospital for Active Treatment Dr Tota Venkova
Gabrovo, , Bulgaria
Medikal Center Kordis
Pleven, , Bulgaria
Skin and Venereal Diseases Center EOOD
Sofia, , Bulgaria
DCC Aleksandrovka
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Alexandrovska
Sofia, , Bulgaria
Rejuvenation Medical Group Edmonton Downtown
Edmonton, Alberta, Canada
Alberta DermaSurgery
Edmonton, Alberta, Canada
VIDA Dermatology/VIDA Clinical Research
Edmonton, Alberta, Canada
CaRe Clinic Red Deer
Red Deer, Alberta, Canada
Enverus Medical
Surrey, British Columbia, Canada
CCA Medical Research Corp
Ajax, Ontario, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada
SKiN Health
Coburg, Ontario, Canada
Guelph Dermatology Research
Guelph, Ontario, Canada
Dermatrials Research Inc
Hamilton, Ontario, Canada
Centricity Research London
London, Ontario, Canada
Derm Effects
London, Ontario, Canada
Lynderm Research
Markham, Ontario, Canada
DermEdge Research Inc
Mississauga, Ontario, Canada
Clear Skin Dermatology
Newmarket, Ontario, Canada
North Bay Dermatolgy Centre
North Bay, Ontario, Canada
Canadian Dermatology Centre
North York, Ontario, Canada
Rejuvenation Dermatology - Oakville
Oakville, Ontario, Canada
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
North York Research Inc
Toronto, Ontario, Canada
Toronto Research Centre
Toronto, Ontario, Canada
Dermatology on Bloor
Toronto, Ontario, Canada
Alliance Clinical Trials Inc
Waterloo, Ontario, Canada
XLR8 Medical Research
Windsor, Ontario, Canada
Innovaderm
Montreal, Quebec, Canada
Centre of Research in Dermatology Quebec CRDQ
Québec, Quebec, Canada
Dermatologie Sima Inc
Verdun, Quebec, Canada
Skinsense Medical Research
Saskatoon, Saskatchewan, Canada
Dermamedica
Náchod, Královéhradecký kraj, Czechia
Vesalion s.r.o
Ostrava, Moravian Silesian, Czechia
Sanatorium Profesora Arenbergera
Prague, Prague, Czechia
Clintrial sro
Prague, Prague, Czechia
Pratia Brno
Brno, , Czechia
Lékárna Pod Kaňkem
Kutná Hora, , Czechia
Nemocnice Novy Jicin
Nový Jičín, , Czechia
Dermskin sro
Olomouc, , Czechia
CCR Ostrava
Ostrava, , Czechia
Pratia Pardubice as
Pardubice, , Czechia
Fakultni nemocnice Plzen Dermatovenerologicka klinika
Pilsen, , Czechia
Fakultni Nemocnice Kralovske Vinohrady FNKV Dermatovenerologicka Klinika
Prague, , Czechia
Pratia Prague
Prague, , Czechia
Praglandia
Prague, , Czechia
Dermatologicka ambulance Svitavy
Svitavy, , Czechia
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
Centre Azur Nice
Nice, Alpes Maritimes, France
CHU de Rouen
Rouen, Essais Cliniques, France
Hautarztpraxis Dr Mihaescu
Augsburg, Augsburg, Germany
Eberhard Karls Universitaet Tuebingen Universitaets Hautklinik Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Universitatsklinikum Erlangen
Erlangen, Bavaria, Germany
Hautarztpraxis Mahlow
Mahlow, Brandenburg, Germany
Rosenpark Research
Darmstadt, Hesse, Germany
Universitatsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, Germany
Hautarztpraxis an der Hase
Bramsche, Lower Saxony, Germany
Klinikum Oldenburg
Oldenburg, Lower Saxony, Germany
Klinische Forschung Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, Germany
Klinikum Bielefeld
Bielefeld, North Rhine-Westphalia, Germany
Hautarztpraxis Dr Niesmann and Dr Othlinghaus
Bochum, North Rhine-Westphalia, Germany
Intramedis CSS
Remscheid, North Rhine-Westphalia, Germany
Dermatologische Praxis Dres Quist
Mainz, Rhinelkand-Palatinate, Germany
Klinische Forschung Dresden GmbH
Dresden, Saxony, Germany
Praxis fur Dermatologie und Venerologie
Dresden, Saxony, Germany
Haut Ambulatorium Magdeburg
Magdeburg, Saxony-Anhalt, Germany
Universitatsklinikum Schleswig Holstein
Kiel, Schleswig-Holstein, Germany
MVZ DermaKiel GmbH
Kiel, Schleswig-Holstein, Germany
Universitatsklinikum Schleswig Holstein
Lübeck, Schleswig-Holstein, Germany
ISA - Interdisciplinary Study Association GmbH
Berlin, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
KliFOs Klinische Forschung Osnabruck
Osnabrück, , Germany
Bacs Kiskun County Teaching Hospital
Kecskemét, Bács-Kiskun county, Hungary
Bőrgyógyászati Klinika, Debreceni Egyetem Orvos - és Egészségtudományi Centrum
Debrecen, Hajdú-Bihar, Hungary
Allergo-Derm Bakos Kft
Szolnok, JN, Hungary
DermaMed Research Kf
Békés, Oroshaza, Hungary
UNO Medical Trials Kft.
Budapest, , Hungary
Orvostudomanyi Kutato es Fejleszto Kft
Debrecen, , Hungary
DERMA B Kft
Debrecen, , Hungary
Medmare Bt
Veszprém, , Hungary
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan
Tokyo Medical University Ibaraki Medical Center
Ibaraki, Inashiki-gun, Japan
Saruwatari Dermatology Clinic
Kagoshima, Kagoshima-Shi, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa-shi, Japan
Kanto Rosai Hospital
Kanagawa, Kawasaki-shi, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Okayama University Hospital
Okayama, Okayama-shi, Japan
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka-shi, Japan
Nippon Life Hospital
Osaka, Osaka-Shi, Japan
Hokkaido University Hospital
Hokkaido, Sapporo-shi, Japan
Kindai University Hospital
Osaka, Sayama-Shi, Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-Ku, Japan
Nihon University Itabashi Hospital
tabashi City, Tokyo, Japan
Medical Corporation Jitai kai Tachikawa Dermatology Clinic
Tachikawa, Tokyo, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Semigallia Ltd
Kuldīga, Kuldigas, Latvia
Riga 1st Hospital
Riga, Rīga, Latvia
SIA Veseliba un estetika
Riga, Rīga, Latvia
Smite Aija medical practice in dermatology venereology
Talsi, Talsi, Latvia
Med Art clinic
Riga, , Latvia
Veselibas Centrs 4
Riga, , Latvia
Veselibas Centrs 4 Filiale Dermatologijas Klinika
Riga, , Latvia
Specderm
Podlaski, Bialystok, Poland
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Synexus Centrum Medyczne Osteomed Wroclaw
Wroclaw, Lower Silesian Voivodeship, Poland
WroMedica
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Medyczne dr Rajzer spolka zoo
Krakow, Malopolska, Poland
Diamond Clinic
Krakow, Malopolska, Poland
RCMed Oddział Sochaczew
Sochaczew, Masovian Voivodeship, Poland
FutureMeds Warszawa Centrum
Warsaw, Masovian Voivodeship, Poland
Clinical Best Solutions
Warsaw, Masovian Voivodeship, Poland
MICS Medical Center Warsaw
Warsaw, Masovian Voivodeship, Poland
High Med Przychodnia Specjalistyczna
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Reuma Park
Warsaw, Masovian Voivodeship, Poland
RoyalDerm
Warsaw, Mazowiecke, Poland
ClinicMed Daniluk Nowak SpK
Bialystok, Podlaskie Voivodeship, Poland
AES Gdansk
Gdansk, Pomeranian Voivodeship, Poland
Pratia Gdynia
Gdynia, Pomeranian Voivodeship, Poland
Derm Art Institute
Gdynia, Pomeranian Voivodeship, Poland
Synexus Sp zo o Oddzial w Gdyni
Gdynia, Pomeranian Voivodeship, Poland
Centrum Badan Klinicznych PI House
Gdansk, Poneranian, Poland
Pratia Katowice
Katowice, Silesian Voivodeship, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, Poland
Research Solutions
Katowice, Silesian Voivodeship, Poland
Laser Clinic
Szczecin, West Pomeranian Voivodeship, Poland
Care Clinic Katowice
Katowice, , Poland
Centrum Medyczne All Med Badania Kliniczne
Krakow, , Poland
Pratia MCM Krakow
Krakow, , Poland
Krakowskie Centrum Medyczne
Krakow, , Poland
Luxderm
Lublin, , Poland
Zanamed Medical Clinic Sp z o o
Lublin, , Poland
Klinika Dermatologii Uniwersytecki Szpital Kliniczny im F Chopina
Rzeszów, , Poland
Rheuma Medicus
Warsaw, , Poland
MTZ Clinical Research Sp z o o
Warsaw, , Poland
Centrum Medyczne Synexus Warszawa
Warsaw, , Poland
Klinika Ambroziak Dermatologia Kliniczna
Warsaw, , Poland
dermMedica
Wroclaw, , Poland
Dermoklinika
Lodz, Łódź Voivodeship, Poland
FutureMeds Lodz
Lodz, Łódź Voivodeship, 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, , Portugal
Centro Reumatologico de Cagus
Caguas, Puerto Rico, Puerto Rico
Ponce Medical School Foundation Inc
Ponce, Puerto Rico, Puerto Rico
Clinical Research Puerto Rico
San Juan, Puerto Rico, Puerto Rico
GCM Medical Group PSC Hato Rey Site
San Juan, , Puerto Rico
Pusan National University Hospital
Seogu, Busan, South Korea
Chosun Universtiy Hospital
Gwangju, Dong-gu, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
University General Hospital Dr Balmis
Alicante, Alicante, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Clínico Universitario de Santiago de Compostela
A Coruña, Santiago de Compostela, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Germans Trias i Pujol
Barcelona, , Spain
Hospital de Manises
Manises, , Spain
Countries
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Central Contacts
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Other Identifiers
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ESK-001-018
Identifier Type: -
Identifier Source: org_study_id
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