Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis (ONWARD3)

An Extension Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy, and Durability of Response to ESK-001

The objective of the ESK-001-018 long term extension is to evaluate the safety and efficacy of ESK-001 over time. The scientific questions it aims to answer are:

• 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Psoriasis; Plaque Psoriasis; Psoriasis (PsO); Moderate Psoriasis; Severe Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: Open-Label Envudeucitinib; Drug: Blinded Envudeucitinib

• Study Type: Interventional
• Enrollment (Estimated): 1680
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Premier Specialist
  • South Australia
    • Campbelltown, South Australia, Australia, 5074
      • North Eastern Health Specialists
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
• Bulgaria
  • Gabrovo, Bulgaria, 5300
    • Multiprofile Hospital For Active Treatment Dr Tota Venkova
  • Pleven, Bulgaria, 5800
    • Medikal Center Kordis
  • Sofia, Bulgaria, 1431
    • University Multiprofile Hospital for Active Treatment Alexandrovska
  • Sofia, Bulgaria, 1404
    • Skin and Venereal Diseases Center EOOD
  • Sofia, Bulgaria, 1431
    • DCC Aleksandrovka
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C3
      • Alberta DermaSurgery
    • Edmonton, Alberta, Canada, T6H 4J8
      • VIDA Dermatology/VIDA Clinical Research
    • Edmonton, Alberta, Canada, T5J 3S9
      • Rejuvenation Medical Group Edmonton Downtown
    • Red Deer, Alberta, Canada, T4P 1K4
      • CARe Clinic Red Deer
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Enverus Medical
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • CCA Medical Research Corp
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical and Surgical Dermatology Center
    • Coburg, Ontario, Canada, K9A 0Z4
      • Skin Health
    • Guelph, Ontario, Canada, N1L 0B3
      • Guelph Dermatology Research
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Dermatrials Research Inc
    • London, Ontario, Canada, N6H 5L5
      • Derm Effects
    • London, Ontario, Canada, N6A 2C2
      • Centricity Research London
    • Markham, Ontario, Canada, L3P1X2
      • Lynderm Research
    • Mississauga, Ontario, Canada, L4Y 4C5
      • DermEdge Research Inc
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Clear Skin Dermatology
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatolgy Centre
    • North York, Ontario, Canada, M3B 0A7
      • Canadian Dermatology Centre
    • Oakville, Ontario, Canada, L6J 7W5
      • Institute of Cosmetic and Laser Surgery
    • Oakville, Ontario, Canada, L6H6P8
      • Rejuvenation Dermatology - Oakville
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Centre for Dermatology
    • Toronto, Ontario, Canada, M4W 2N4
      • Dermatology on Bloor
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Research Centre
    • Toronto, Ontario, Canada, M2N 3A6
      • North York Research Inc
    • Waterloo, Ontario, Canada, N2J 1C4
      • Alliance Clinical Trials Inc
    • Windsor, Ontario, Canada, N8T 1E6
      • XLR8 Medical Research
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm
    • Québec, Quebec, Canada, G1V 4X7
      • Centre of Research in Dermatology Quebec CRDQ
    • Verdun, Quebec, Canada, H4G 3E7
      • Dermatologie Sima Inc
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 2C1
      • Skinsense Medical Research
• Czechia
  • Brno, Czechia, 602 00
    • Pratia Brno
  • Kutná Hora, Czechia, 284 01
    • Lékárna Pod Kaňkem
  • Nový Jičín, Czechia, 74101
    • Nemocnice Novy Jicin
  • Olomouc, Czechia, 77900
    • Dermskin sro
  • Ostrava, Czechia, 70200
    • CCR Ostrava
  • Pardubice, Czechia, 530 02
    • Pratia Pardubice as
  • Pilsen, Czechia, 301 00
    • Fakultni nemocnice Plzen Dermatovenerologicka klinika
  • Prague, Czechia, 10034
    • Fakultni Nemocnice Kralovske Vinohrady FNKV Dermatovenerologicka Klinika
  • Prague, Czechia, 15000
    • Praglandia
  • Prague, Czechia, 101 00
    • Pratia Prague
  • Svitavy, Czechia, 568 02
    • Dermatologicka ambulance Svitavy
  • Královéhradecký kraj
    • Náchod, Královéhradecký kraj, Czechia, 547 01
      • Dermamedica
  • Moravian Silesian
    • Ostrava, Moravian Silesian, Czechia, 70200
      • Vesalion s.r.o
  • Prague
    • Prague, Prague, Czechia, 1 110 00
      • Sanatorium Profesora Arenbergera
    • Prague, Prague, Czechia, 100 00
      • Clintrial sro
• Estonia
  • Tallinn, Estonia, 10128
    • Center for Clinical and Basic Research AS
  • Tartu, Estonia, 50106
    • Kliiniliste Uuringute Keskus OU
  • Harju
    • Tallinn, Harju, Estonia, 10117
      • Innomedica
  • Tartu
    • Tartu, Tartu, Estonia, 50417
      • Tartu University Hospital
• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 6000
      • Centre Azur Nice
  • Essais Cliniques
    • Rouen, Essais Cliniques, France, 76031
      • CHU de Rouen
• Germany
  • Berlin, Germany, 10789
    • ISA - Interdisciplinary Study Association GmbH
  • Münster, Germany, NRW 48149
    • Universitaetsklinikum Muenster
  • Osnabrück, Germany, 49074
    • KliFOs Klinische Forschung Osnabruck
  • Augsburg
    • Augsburg, Augsburg, Germany, 86150
      • Hautarztpraxis Dr Mihaescu
  • Baden-Wurttemberg
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Eberhard Karls Universitaet Tuebingen Universitaets Hautklinik Tuebingen
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Universitätsklinikum Erlangen
  • Brandenburg
    • Mahlow, Brandenburg, Germany, 15831
      • Hautarztpraxis Mahlow
  • Hesse
    • Darmstadt, Hesse, Germany, 64283
      • Rosenpark Research
    • Frankfurt am Main, Hesse, Germany, 60590
      • Universitätsklinikum Frankfurt
  • Lower Saxony
    • Bad Bentheim, Lower Saxony, Germany, 48455
      • Fachklinik Bad Bentheim
    • Bramsche, Lower Saxony, Germany, 49565
      • Hautarztpraxis an der Hase
    • Oldenburg, Lower Saxony, Germany, 26133
      • Klinikum Oldenburg
  • Mecklenburg-Vorpommern
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
      • Klinische forschung Schwerin GmbH
  • North Rhine-Westphalia
    • Bielefeld, North Rhine-Westphalia, Germany, 33647
      • Klinikum Bielefeld
    • Bochum, North Rhine-Westphalia, Germany, 44793
      • Hautarztpraxis Dr Niesmann and Dr Othlinghaus
    • Remscheid, North Rhine-Westphalia, Germany, 42897
      • Intramedis CSS
  • Rhinelkand-Palatinate
    • Mainz, Rhinelkand-Palatinate, Germany, 55128
      • Dermatologische Praxis Dres Quist
  • Saxony
    • Dresden, Saxony, Germany, 1069
      • Klinische Forschung Dresden GmbH
    • Dresden, Saxony, Germany, 1097
      • Praxis fur Dermatologie und Venerologie
  • Saxony-Anhalt
    • Magdeburg, Saxony-Anhalt, Germany, 39104
      • Haut Ambulatorium Magdeburg
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitatsklinikum Schleswig Holstein
    • Kiel, Schleswig-Holstein, Germany, 24148
      • MVZ DermaKiel GmbH
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Universitatsklinikum Schleswig Holstein
• Hungary
  • Budapest, Hungary, 1152
    • UNO Medical Trials Kft.
  • Debrecen, Hungary, 4027
    • Orvostudomanyi Kutato es Fejleszto Kft
  • Debrecen, Hungary, 4031
    • DERMA B Kft
  • Veszprém, Hungary, 8200
    • Medmare Bt
  • Bács-Kiskun county
    • Kecskemét, Bács-Kiskun county, Hungary, 6000
      • Bacs Kiskun County Teaching Hospital
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Bőrgyógyászati Klinika, Debreceni Egyetem Orvos - és Egészségtudományi Centrum
  • JN
    • Szolnok, JN, Hungary, 5000
      • Allergo-Derm Bakos Kft
  • Oroshaza
    • Békés, Oroshaza, Hungary, 5900
      • DermaMed Research Kf
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Nagoya City University Hospital
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 814-0180
      • Fukuoka University Hospital
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 078-8510
      • Asahikawa Medical University Hospital
  • Inashiki-gun
    • Ibaraki, Inashiki-gun, Japan, 300-0395
      • Tokyo Medical University Ibaraki Medical Center
  • Kagoshima-Shi
    • Kagoshima, Kagoshima-Shi, Japan, 890-0046
      • Saruwatari Dermatology Clinic
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0392
      • National Hospital Organization Sagamihara National Hospital
  • Kanagawa-shi
    • Yokohama, Kanagawa-shi, Japan, 236-0004
      • Yokohama City University Hospital
  • Kawasaki-shi
    • Kanagawa, Kawasaki-shi, Japan, 211-8510
      • Kanto Rosai Hospital
  • Mie-ken
    • Tsu, Mie-ken, Japan, 514-8507
      • Mie University Hospital
  • Okayama-shi
    • Okayama, Okayama-shi, Japan, 700-8558
      • Okayama University Hospital
  • Osaka
    • Sakai, Osaka, Japan, 593-8324
      • Dermatology and Ophthalmology Kume Clinic
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Osaka-Shi
    • Osaka, Osaka-Shi, Japan, 550-0006
      • Nippon Life Hospital
  • Osaka-shi
    • Osaka, Osaka-shi, Japan, 545-8586
      • Osaka Metropolitan University Hospital
  • Sapporo-shi
    • Hokkaido, Sapporo-shi, Japan, 060-8648
      • Hokkaido University Hospital
  • Sayama-Shi
    • Osaka, Sayama-Shi, Japan, 589-8511
      • Kindai University Hospital
  • Shinjuku-Ku
    • Tokyo, Shinjuku-Ku, Japan, 160-0023
      • Tokyo Medical University Hospital
  • Tokyo
    • Tachikawa, Tokyo, Japan, 190-0023
      • Medical Corporation Jitai kai Tachikawa Dermatology Clinic
    • tabashi City, Tokyo, Japan, 173-8610
      • Nihon University Itabashi Hospital
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
      • Yamaguchi University Hospital
• Latvia
  • Riga, Latvia, LV1003
    • Med Art Clinic
  • Riga, Latvia, LV1003
    • Veselibas Centrs 4
  • Riga, Latvia, LV1013
    • Veselibas Centrs 4 Filiale Dermatologijas Klinika
  • Kuldigas
    • Kuldīga, Kuldigas, Latvia, LV3301
      • Semigallia Ltd
  • Rīga
    • Riga, Rīga, Latvia, LV1001
      • Riga 1st Hospital
    • Riga, Rīga, Latvia, LV1009
      • SIA Veseliba un estetika
  • Talsi
    • Talsi, Talsi, Latvia, LV3201
      • Smite Aija Medical Practice in Dermatology Venereology
• Poland
  • Katowice, Poland, 40-568
    • Care Clinic Katowice
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne
  • Krakow, Poland, 30-727
    • Pratia McM Krakow
  • Krakow, Poland, 30-033
    • Centrum Medyczne All Med Badania Kliniczne
  • Lublin, Poland, 20-573
    • Luxderm
  • Lublin, Poland, 20-601
    • Zanamed Medical Clinic sp z o o
  • Rzeszów, Poland, 35-329
    • Klinika Dermatologii Uniwersytecki Szpital Kliniczny im F Chopina
  • Warsaw, Poland, 02-172
    • MTZ Clinical Research Sp z o o
  • Warsaw, Poland, 02-118
    • Rheuma Medicus
  • Warsaw, Poland, 02-672
    • Centrum Medyczne Synexus Warszawa
  • Warsaw, Poland, 02-953
    • Klinika Ambroziak Dermatologia Kliniczna
  • Wroclaw, Poland, 51-503
    • dermMedica
  • Bialystok
    • Podlaski, Bialystok, Poland, 15 - 375
      • Specderm
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
      • Centrum Medyczne Pratia Bydgoszcz
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 51-685
      • WroMedica
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-381
      • Synexus Centrum Medyczne Osteomed Wroclaw
  • Malopolska
    • Krakow, Malopolska, Poland, 31-559
      • Diamond Clinic
    • Krakow, Malopolska, Poland, 30-438
      • Centrum Medyczne dr Rajzer Spolka Zoo
  • Masovian Voivodeship
    • Sochaczew, Masovian Voivodeship, Poland, 96-500
      • RCMed Oddział Sochaczew
    • Warsaw, Masovian Voivodeship, Poland, 00-215
      • FutureMeds Warszawa Centrum
    • Warsaw, Masovian Voivodeship, Poland, 00-710
      • Clinical Best Solutions
    • Warsaw, Masovian Voivodeship, Poland, 02-625
      • Centrum Medyczne Evimed
    • Warsaw, Masovian Voivodeship, Poland, 00-874
      • MICS Medical Center Warsaw
    • Warsaw, Masovian Voivodeship, Poland, 01-817
      • High Med Przychodnia Specjalistyczna
    • Warsaw, Masovian Voivodeship, Poland, 02-665
      • Centrum Medyczne Reuma Park
  • Mazowiecke
    • Warsaw, Mazowiecke, Poland, 02-962
      • Royalderm
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-879
      • ClinicMed Daniluk Nowak SpK
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-382
      • AES Gdansk
    • Gdynia, Pomeranian Voivodeship, Poland, 81-338
      • Pratia Gdynia
    • Gdynia, Pomeranian Voivodeship, Poland, 81-415
      • Derm Art Institute
    • Gdynia, Pomeranian Voivodeship, Poland, 81-537
      • Synexus Sp zo o Oddzial w Gdyni
  • Poneranian
    • Gdansk, Poneranian, Poland, 80-546
      • Centrum Badan Klinicznych PI House
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-611
      • Centrum Medyczne Angelius Provita
    • Katowice, Silesian Voivodeship, Poland, 40-018
      • Pratia Katowice
    • Katowice, Silesian Voivodeship, Poland, 40-748
      • Research Solutions
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 70-332
      • Laser Clinic
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 90-436
      • Dermoklinika
    • Lodz, Łódź Voivodeship, Poland, 91-363
      • FutureMeds Lodz
    • Skierniewice, Łódź Voivodeship, Poland, 96-100
      • Velocity Clinical Research Skierniewice
• Portugal
  • Porto, Portugal, 4099-001
    • Unidade Local de Saude Santo Antonio Hospital de Santo Antonio
  • Braga District
    • Guimarães, Braga District, Portugal, 4835-044
      • Hospital da Senhora da Oliveira
  • Lisbon District
    • Lisbon, Lisbon District, Portugal, 1998-018
      • Hospital CUF Descobertas
• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • GCM Medical Group PSC Hato Rey Site
  • Puerto Rico
    • Caguas, Puerto Rico, Puerto Rico, 00725
      • Centro Reumatologico de Cagus
    • Ponce, Puerto Rico, Puerto Rico, 00716
      • Ponce Medical School Foundation Inc
    • San Juan, Puerto Rico, Puerto Rico, 00909
      • Clinical Research Puerto Rico
• South Korea
  • Seoul, South Korea, 3080
    • Seoul National University Hospital
  • Seoul, South Korea, 5030
    • Konkuk University Medical Center
  • Busan
    • Seogu, Busan, South Korea, 49241
      • Pusan National University Hospital
  • Dong-gu
    • Gwangju, Dong-gu, South Korea, 61453
      • Chosun Universtiy Hospital
  • Gyeonggi-do
    • Anyang-si, Gyeonggi-do, South Korea, 14068
      • Hallym University Sacred Heart Hospital
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
• Spain
  • Barcelona, Spain, 8041
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 8916
    • Hospital Germans Trias i Pujol
  • Manises, Spain, 46940
    • Hospital de Manises
  • Alicante
    • Alicante, Alicante, Spain, 3010
      • University General Hospital Dr Balmis
  • Barcelona
    • Barcelona, Barcelona, Spain, 8003
      • Hospital del Mar
  • Madrid
    • Madrid, Madrid, Spain, 28046
      • Hospital Universitario La Paz
  • Santiago de Compostela
    • A Coruña, Santiago de Compostela, Spain, 15706
      • Hospital Clinico Universitario de Santiago de Compostela
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35203
      • Total Dermatology
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Chandler Clinical Trials
    • Pheonix, Arizona, United States, 85032
      • Alliance Dermatology
    • Scottsdale, Arizona, United States, 85260
      • Scottsdale Clinical Trials
    • Tucson, Arizona, United States, 85704
      • Noble Clinical Research
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Northwest AR Clinical Trials Center PLLC
  • California
    • Beverly Hills, California, United States, 90212
      • Zenith Research Inc.
    • Chula Vista, California, United States, 91910
      • Exalt Clinical Research Inc
    • Encinitas, California, United States, 92024
      • California Dermatology and Clinical Research Institute
    • Encino, California, United States, 91436
      • Raoof MD
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology Research Inc
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research LLC
    • Long Beach, California, United States, 90805
      • Long Beach Research Institute
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Los Angeles, California, United States, 90056
      • Wallace Medical Group Inc
    • Los Angeles, California, United States, 90024
      • Olive View UCLA Education and Research Institute
    • Northridge, California, United States, 91325
      • Northridge Clinical Trials
    • Pasadena, California, United States, 91101
      • Pasadena Clinical Trials
    • Pomona, California, United States, 91767
      • Empire Clinical Research Pomona
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • Santa Ana, California, United States, 92701
      • Southern California Clinical Research
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute Dermatology Institute
    • Sherman Oaks, California, United States, 91403
      • Unison Clinical Trials
    • Thousand Oaks, California, United States, 91320
      • California Dermatology Institute Thousand Oaks
    • Walnut Creek, California, United States, 94596
      • Sunwise Clinical Research LLC
  • Florida
    • Boca Raton, Florida, United States, 33428
      • Clearlyderm Dermatology West Boca Raton
    • Coral Gables, Florida, United States, 33134
      • Driven Clinical Research
    • Fort Lauderdale, Florida, United States, 33308
      • FXM Clinical Research Ft. Lauderdale LLC
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Margate, Florida, United States, 33063
      • Glick Skin Institute
    • Miami, Florida, United States, 33175
      • FXM Clinical Research Miami LLC
    • Miami, Florida, United States, 33126
      • AppleMed Research Group
    • Miami, Florida, United States, 33196
      • Las Mercedes Medical Research
    • Miami, Florida, United States, 33146
      • FAX Pharma Clinical Research Inc
    • Miami Gardens, Florida, United States, 33014
      • Procare Research Center
    • Miami Lakes, Florida, United States, 33014
      • Savin Medical Group LLC
    • Miami Lakes, Florida, United States, 33014
      • San Marcus Research Clinic Inc - Miami
    • Miramar, Florida, United States, 33027
      • FXM Clinical Research Miramar LLC
    • North Miami Beach, Florida, United States, 33169
      • Oceanic Research Group
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Sweetwater, Florida, United States, 33172
      • Lenus Research and Medical Group LLC
    • Tampa, Florida, United States, 33613
      • ForCare Medical Center
    • Tampa, Florida, United States, 33607
      • Advanced Clinical Research Institute
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
    • Skokie, Illinois, United States, 60077
      • NorthShore Medical Group Dermatology Skokie
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Clarksville, Indiana, United States, 47129
      • DS Research of Southern Indiana
    • Columbus, Indiana, United States, 47201
      • Dawes Fretzin Clinical Research Group
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic
  • Kentucky
    • Bowling Green, Kentucky, United States, 42104
      • Equity Medical
    • Louisville, Kentucky, United States, 40241
      • DS Research of Kentucky
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Velocity Clinical Research
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • MetroBoston Clinical Partners
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Michigan Center for Research Company
    • Detroit, Michigan, United States, 48202
      • Henry Ford Medical Center Farmington
    • Troy, Michigan, United States, 48084
      • Revival Research Institute
    • Warren, Michigan, United States, 48088
      • Grekin Skin Institute
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Associated Skin Care Specialists Minnesota Clinical Study Center
  • Missouri
    • Kirksville, Missouri, United States, 63501
      • Cleaver Dermatology
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Schlessinger MD
  • Nevada
    • Las Vegas, Nevada, United States, 89030
      • Las Vegas Clinical Trials
  • New York
    • Elmhurst, New York, United States, 11373
      • NYC Health and Hospitals Elmhurst
    • New York, New York, United States, 10128
      • OPTISKIN
    • New York, New York, United States, 10016
      • Pioneer Clinical Research NY
    • New York, New York, United States, 10023
      • Cameron Dermatology
    • Stony Brook, New York, United States, 11790
      • DermResearchCenter of New York
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Clinical Trials
    • Wilmington, North Carolina, United States, 28405
      • WDC Cosmetic and Research
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Optima Research Boardman
    • Gahanna, Ohio, United States, 43230
      • The Ohio State University Wexner Medical Center OSUWMC OSU Dermatology East Columbus
    • Mason, Ohio, United States, 45040
      • Dermatologists of Southwestern Ohio LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Unity Clinical Research UCR
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research
    • Portland, Oregon, United States, 97201
      • Oregon Medical Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Company Inc
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Department of Dermatology
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners LLC
  • Texas
    • Cypress, Texas, United States, 77433
      • Studies in Dermatology LLC
    • Dallas, Texas, United States, 75231
      • Modern Research Associates PLLC
    • Frisco, Texas, United States, 75033
      • Reveal Research Institute
    • Houston, Texas, United States, 77056
      • Austin Institute for Clinical Research
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies Texas Medical Center
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research San Antonio
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies (CCS) - Webster/Clear Lake Location
  • Utah
    • Murray, Utah, United States, 84107
      • University of Utah Health Care Midvalley Health Center
    • South Jordan, Utah, United States, 84095
      • Jordan Valley Dermatology
  • Washington
    • Mill Creek, Washington, United States, 98012
      • Frontier Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males or females, age ≥18 years
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:

1. Pregnant, lactating, or planning to get pregnant during the study period
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-Label ESK-001; Open-Label ESK-001 administered as an oral tablet	Drug: Open-Label Envudeucitinib; Open-Label ESK-001
Experimental: Blinded ESK-001; Blinded ESK-001 administered as an oral tablet	Drug: Blinded Envudeucitinib; Blinded ESK-001 during Randomized Treatment Withdrawal Period
Placebo Comparator: Placebo; Matching placebo administered as an oral tablet	Drug: Placebo; Placebo during Randomized Treatment Withdrawal Period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the long-term safety and tolerability of ESK-001 throughout the duration of the study	Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	Approximately 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-75)	Proportion of patients achieving ≥75% reduction in PASI	24, 48, 72, and 96 weeks
To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-90)	Proportion of patients achieving ≥90% reduction in PASI	24, 48, 72, and 96 weeks
To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-100)	Proportion of patients achieving 100% reduction in PASI	24, 48, 72, and 96 weeks
To assess the long-term efficacy of ESK-001 using the Static Physician's Global Assessment (sPGA 0/1)	Proportion of patients achieving a score of 0 or 1 on sPGA	24, 48, 72, and 96 weeks
To assess the long-term efficacy of ESK-001 based on change in Psoriasis Area and Severity Index (PASI)	Change in Psoriasis Area and Severity Index (PASI) from baseline assessments	24, 48, 72, and 96 weeks
To assess the long-term efficacy of ESK-001 based on change in Affected Body Surface Area (%BSA)	Change in affected body surface area (%BSA) from baseline assessments	24, 48, 72, and 96 weeks
To characterize the loss of PASI-75 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)	Median time to loss of PASI-75 response	Week 48
To characterize the loss of PASI-90 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)	Median time to loss of PASI-90 response	Week 48
To characterize the loss of sPGA-0/1 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)	Median time to loss of sPGA-0/1 response	Week 48
To assess the change in quality of life (QoL) using Dermatology Life Quality Index after long-term ESK-001 administration	Proportion of patients achieving a DLQI-0/1 score of 0 (no effect) or 1 (minimal effect)	Week 24, Week 48, and Week 72

Collaborators and Investigators

• Sponsor: Alumis Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Psoriasis; PASI; ESK-001
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: ESK-001-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The Sponsor Alumis Inc. is a clinical-stage biopharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No