AzTrials
AzTrials

Plaque PsoriasisPhase 3ONWARD3NCT06846541

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

A Phase 3 study testing Open-Label Envudeucitinib and Blinded Envudeucitinib in people with Plaque Psoriasis and Psoriasis (PsO), run by Alumis Inc at 268 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis, Psoriasis (PsO), Psoriasis
What is being tested?
Open-Label Envudeucitinib and Blinded Envudeucitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,680 participants
Where
268 sitesin 16 countries
Study dates
8 Jan 2025to Nov 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females, age ≥18 years
  • Completed either of the two previous (parent) studies of ESK-001 (ESK-001-016 or ESK-001-017)
  • ESK-001 safety and tolerability were acceptable in the parent study
  • 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

Who cannot join

  • Pregnant, lactating, or planning to get pregnant during the study period
  • 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
  • Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol

Trial locations and contacts

268 sites in 16 countries.

268 sites in 16 countries

United States92 sites

  • Asheville Clinical Trials

    Asheville, North Carolina, 28803

  • Velocity Clinical Research

    Baton Rouge, Louisiana, 70808

  • Zenith Research Inc.

    Beverly Hills, California, 90212

  • Total Dermatology

    Birmingham, Alabama, 35203

  • Optima Research Boardman

    Boardman, Ohio, 44512

  • Clearlyderm Dermatology West Boca Raton

    Boca Raton, Florida, 33428

  • Equity Medical

    Bowling Green, Kentucky, 42104

  • MetroBoston Clinical Partners

    Brighton, Massachusetts, 02135

  • Chandler Clinical Trials

    Chandler, Arizona, 85224

  • Exalt Clinical Research Inc

    Chula Vista, California, 91910

  • Michigan Center for Research Company

    Clarkston, Michigan, 48346

  • DS Research of Southern Indiana

    Clarksville, Indiana, 47129

  • Dawes Fretzin Clinical Research Group

    Columbus, Indiana, 47201

  • Driven Clinical Research

    Coral Gables, Florida, 33134

  • Studies in Dermatology LLC

    Cypress, Texas, 77433

  • Modern Research Associates PLLC

    Dallas, Texas, 75231

  • Henry Ford Medical Center Farmington

    Detroit, Michigan, 48202

  • NYC Health and Hospitals Elmhurst

    Elmhurst, New York, 11373

  • California Dermatology and Clinical Research Institute

    Encinitas, California, 92024

  • Raoof MD

    Encino, California, 91436

  • FXM Clinical Research Ft. Lauderdale LLC

    Fort Lauderdale, Florida, 33308

  • First OC Dermatology Research Inc

    Fountain Valley, California, 92708

  • Reveal Research Institute

    Frisco, Texas, 75033

  • The Ohio State University Wexner Medical Center OSUWMC OSU Dermatology East Columbus

    Gahanna, Ohio, 43230

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Center for Clinical Studies Texas Medical Center

    Houston, Texas, 77004

  • Austin Institute for Clinical Research

    Houston, Texas, 77056

  • Marvel Clinical Research LLC

    Huntington Beach, California, 92647

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Clinical Partners LLC

    Johnston, Rhode Island, 02919

  • Cleaver Dermatology

    Kirksville, Missouri, 63501

  • Las Vegas Clinical Trials

    Las Vegas, Nevada, 89030

  • Long Beach Research Institute

    Long Beach, California, 90805

  • Olive View UCLA Education and Research Institute

    Los Angeles, California, 90024

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • Wallace Medical Group Inc

    Los Angeles, California, 90056

  • DS Research of Kentucky

    Louisville, Kentucky, 40241

  • Glick Skin Institute

    Margate, Florida, 33063

  • Dermatologists of Southwestern Ohio LLC

    Mason, Ohio, 45040

  • Velocity Clinical Research

    Medford, Oregon, 97504

  • SMS Clinical Research

    Mesquite, Texas, 75149

  • AppleMed Research Group

    Miami, Florida, 33126

  • FAX Pharma Clinical Research Inc

    Miami, Florida, 33146

  • FXM Clinical Research Miami LLC

    Miami, Florida, 33175

  • Las Mercedes Medical Research

    Miami, Florida, 33196

  • Procare Research Center

    Miami Gardens, Florida, 33014

  • San Marcus Research Clinic Inc - Miami

    Miami Lakes, Florida, 33014

  • Savin Medical Group LLC

    Miami Lakes, Florida, 33014

  • Frontier Dermatology

    Mill Creek, Washington, 98012

  • FXM Clinical Research Miramar LLC

    Miramar, Florida, 33027

  • University of Utah Health Care Midvalley Health Center

    Murray, Utah, 84107

  • Associated Skin Care Specialists Minnesota Clinical Study Center

    New Brighton, Minnesota, 55112

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Pioneer Clinical Research NY

    New York, New York, 10016

  • Cameron Dermatology

    New York, New York, 10023

  • OptiSkin

    New York, New York, 10128

  • Oceanic Research Group

    North Miami Beach, Florida, 33169

  • Northridge Clinical Trials

    Northridge, California, 91325

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Unity Clinical Research UCR

    Oklahoma City, Oklahoma, 73118

  • Schlessinger MD

    Omaha, Nebraska, 68144

  • Pasadena Clinical Trials

    Pasadena, California, 91101

  • Alliance Dermatology

    Pheonix, Arizona, 85032

  • Paddington Testing Company Inc

    Philadelphia, Pennsylvania, 19103

  • UPMC Department of Dermatology

    Pittsburgh, Pennsylvania, 15213

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • Empire Clinical Research Pomona

    Pomona, California, 91767

  • Oregon Medical Research Center

    Portland, Oregon, 97201

  • Northwest AR Clinical Trials Center PLLC

    Rogers, Arkansas, 72758

  • Arlington Dermatology

    Rolling Meadows, Illinois, 60008

  • Integrative Skin Science and Research

    Sacramento, California, 95815

  • Progressive Clinical Research San Antonio

    San Antonio, Texas, 78213

  • Therapeutics Clinical Research

    San Diego, California, 92123

  • Southern California Clinical Research

    Santa Ana, California, 92701

  • Clinical Science Institute Dermatology Institute

    Santa Monica, California, 90404

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260

  • Unison Clinical Trials

    Sherman Oaks, California, 91403

  • NorthShore Medical Group Dermatology Skokie

    Skokie, Illinois, 60077

  • The South Bend Clinic

    South Bend, Indiana, 46617

  • Jordan Valley Dermatology

    South Jordan, Utah, 84095

  • DermResearchCenter of New York

    Stony Brook, New York, 11790

  • Lenus Research and Medical Group LLC

    Sweetwater, Florida, 33172

  • Advanced Clinical Research Institute

    Tampa, Florida, 33607

  • ForCare Medical Center

    Tampa, Florida, 33613

  • California Dermatology Institute Thousand Oaks

    Thousand Oaks, California, 91320

  • Revival Research Institute

    Troy, Michigan, 48084

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • Sunwise Clinical Research LLC

    Walnut Creek, California, 94596

  • Grekin Skin Institute

    Warren, Michigan, 48088

  • Center for Clinical Studies (CCS) - Webster/Clear Lake Location

    Webster, Texas, 77598

  • Dundee Dermatology

    West Dundee, Illinois, 60118

  • WDC Cosmetic and Research

    Wilmington, North Carolina, 28405

Other trials in United States

Poland39 sites

  • ClinicMed Daniluk Nowak SpK

    Bialystok, Podlaskie Voivodeship, 15-879

  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • AES Gdansk

    Gdansk, Pomeranian Voivodeship, 80-382

  • Centrum Badan Klinicznych PI House

    Gdansk, Poneranian, 80-546

  • Pratia Gdynia

    Gdynia, Pomeranian Voivodeship, 81-338

  • Derm Art Institute

    Gdynia, Pomeranian Voivodeship, 81-415

  • Synexus Sp zo o Oddzial w Gdyni

    Gdynia, Pomeranian Voivodeship, 81-537

  • Pratia Katowice

    Katowice, Silesian Voivodeship, 40-018

  • Centrum Medyczne Angelius Provita

    Katowice, Silesian Voivodeship, 40-611

  • Research Solutions

    Katowice, Silesian Voivodeship, 40-748

  • Care Clinic Katowice

    Katowice, 40-568

  • Centrum Medyczne dr Rajzer spolka zoo

    Krakow, Malopolska, 30-438

  • Diamond Clinic

    Krakow, Malopolska, 31-559

  • Centrum Medyczne All Med Badania Kliniczne

    Krakow, 30-033

  • Pratia MCM Krakow

    Krakow, 30-727

  • Krakowskie Centrum Medyczne

    Krakow, 31-501

  • Dermoklinika

    Lodz, Łódź Voivodeship, 90-436

  • FutureMeds Lodz

    Lodz, Łódź Voivodeship, 91-363

  • Luxderm

    Lublin, 20-573

  • Zanamed Medical Clinic Sp z o o

    Lublin, 20-601

  • Specderm

    Podlaski, Bialystok, 15 - 375

  • Klinika Dermatologii Uniwersytecki Szpital Kliniczny im F Chopina

    Rzeszów, 35-329

  • Velocity Clinical Research Skierniewice

    Skierniewice, Łódź Voivodeship, 96-100

  • RCMed Oddział Sochaczew

    Sochaczew, Masovian Voivodeship, 96-500

  • Laser Clinic

    Szczecin, West Pomeranian Voivodeship, 70-332

  • FutureMeds Warszawa Centrum

    Warsaw, Masovian Voivodeship, 00-215

  • Clinical Best Solutions

    Warsaw, Masovian Voivodeship, 00-710

  • MICS Medical Center Warsaw

    Warsaw, Masovian Voivodeship, 00-874

  • High Med Przychodnia Specjalistyczna

    Warsaw, Masovian Voivodeship, 01-817

  • Centrum Medyczne Evimed

    Warsaw, Masovian Voivodeship, 02-625

  • Centrum Medyczne Reuma Park

    Warsaw, Masovian Voivodeship, 02-665

  • RoyalDerm

    Warsaw, Mazowiecke, 02-962

  • Rheuma Medicus

    Warsaw, 02-118

  • MTZ Clinical Research Sp z o o

    Warsaw, 02-172

  • Centrum Medyczne Synexus Warszawa

    Warsaw, 02-672

  • Klinika Ambroziak Dermatologia Kliniczna

    Warsaw, 02-953

  • Synexus Centrum Medyczne Osteomed Wroclaw

    Wroclaw, Lower Silesian Voivodeship, 50-381

  • WroMedica

    Wroclaw, Lower Silesian Voivodeship, 51-685

  • dermMedica

    Wroclaw, 51-503

Other trials in Poland

Canada29 sites

  • CCA Medical Research Corp

    Ajax, Ontario, L1S 7K8

  • SimcoDerm Medical and Surgical Dermatology Center

    Barrie, Ontario, L4M 7G1

  • SKiN Health

    Coburg, Ontario, K9A 0Z4

  • Rejuvenation Medical Group Edmonton Downtown

    Edmonton, Alberta, T5J 3S9

  • Alberta DermaSurgery

    Edmonton, Alberta, T6G 1C3

  • VIDA Dermatology/VIDA Clinical Research

    Edmonton, Alberta, T6H 4J8

  • Guelph Dermatology Research

    Guelph, Ontario, N1L 0B3

  • Dermatrials Research Inc

    Hamilton, Ontario, L8N 1Y2

  • Centricity Research London

    London, Ontario, N6A 2C2

  • Derm Effects

    London, Ontario, N6H 5L5

  • Lynderm Research

    Markham, Ontario, L3P1X2

  • DermEdge Research Inc

    Mississauga, Ontario, L4Y 4C5

  • Innovaderm

    Montreal, Quebec, H2X 2V1

  • Clear Skin Dermatology

    Newmarket, Ontario, L3Y 5G8

  • North Bay Dermatolgy Centre

    North Bay, Ontario, P1B 3Z7

  • Canadian Dermatology Centre

    North York, Ontario, M3B 0A7

  • Rejuvenation Dermatology - Oakville

    Oakville, Ontario, L6H6P8

  • Institute of Cosmetic and Laser Surgery

    Oakville, Ontario, L6J 7W5

  • Centre of Research in Dermatology Quebec CRDQ

    Québec, Quebec, G1V 4X7

  • CaRe Clinic Red Deer

    Red Deer, Alberta, T4P 1K4

  • The Centre for Dermatology

    Richmond Hill, Ontario, L4B 1A5

  • Skinsense Medical Research

    Saskatoon, Saskatchewan, S7K 2C1

  • Enverus Medical

    Surrey, British Columbia, V3V 0C6

  • North York Research Inc

    Toronto, Ontario, M2N 3A6

  • Toronto Research Centre

    Toronto, Ontario, M3H 5Y8

  • Dermatology on Bloor

    Toronto, Ontario, M4W 2N4

  • Dermatologie Sima Inc

    Verdun, Quebec, H4G 3E7

  • Alliance Clinical Trials Inc

    Waterloo, Ontario, N2J 1C4

  • XLR8 Medical Research

    Windsor, Ontario, N8T 1E6

Other trials in Canada

Germany23 sites

  • Hautarztpraxis Dr Mihaescu

    Augsburg, Augsburg, 86150

  • Fachklinik Bad Bentheim

    Bad Bentheim, Lower Saxony, 48455

  • ISA - Interdisciplinary Study Association GmbH

    Berlin, 10789

  • Klinikum Bielefeld

    Bielefeld, North Rhine-Westphalia, 33647

  • Hautarztpraxis Dr Niesmann and Dr Othlinghaus

    Bochum, North Rhine-Westphalia, 44793

  • Hautarztpraxis an der Hase

    Bramsche, Lower Saxony, 49565

  • Rosenpark Research

    Darmstadt, Hesse, 64283

  • Klinische Forschung Dresden GmbH

    Dresden, Saxony, 1069

  • Praxis fur Dermatologie und Venerologie

    Dresden, Saxony, 1097

  • Universitatsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Universitatsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60590

  • Universitatsklinikum Schleswig Holstein

    Kiel, Schleswig-Holstein, 24105

  • MVZ DermaKiel GmbH

    Kiel, Schleswig-Holstein, 24148

  • Universitatsklinikum Schleswig Holstein

    Lübeck, Schleswig-Holstein, 23538

  • Haut Ambulatorium Magdeburg

    Magdeburg, Saxony-Anhalt, 39104

  • Hautarztpraxis Mahlow

    Mahlow, Brandenburg, 15831

  • Dermatologische Praxis Dres Quist

    Mainz, Rhinelkand-Palatinate, 55128

  • Universitaetsklinikum Muenster

    Münster, NRW 48149

  • Klinikum Oldenburg

    Oldenburg, Lower Saxony, 26133

  • KliFOs Klinische Forschung Osnabruck

    Osnabrück, 49074

  • Intramedis CSS

    Remscheid, North Rhine-Westphalia, 42897

  • Klinische Forschung Schwerin GmbH

    Schwerin, Mecklenburg-Vorpommern, 19055

  • Eberhard Karls Universitaet Tuebingen Universitaets Hautklinik Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Japan20 sites

  • Asahikawa Medical University Hospital

    Asahikawa, Hokkaido, 078-8510

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Hokkaido University Hospital

    Hokkaido, Sapporo-shi, 060-8648

  • Tokyo Medical University Ibaraki Medical Center

    Ibaraki, Inashiki-gun, 300-0395

  • Saruwatari Dermatology Clinic

    Kagoshima, Kagoshima-Shi, 890-0046

  • Kanto Rosai Hospital

    Kanagawa, Kawasaki-shi, 211-8510

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Okayama University Hospital

    Okayama, Okayama-shi, 700-8558

  • Osaka Metropolitan University Hospital

    Osaka, Osaka-shi, 545-8586

  • Nippon Life Hospital

    Osaka, Osaka-Shi, 550-0006

  • Kindai University Hospital

    Osaka, Sayama-Shi, 589-8511

  • National Hospital Organization Sagamihara National Hospital

    Sagamihara, Kanagawa, 252-0392

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, Osaka, 593-8324

  • Osaka University Hospital

    Suita, Osaka, 565-0871

  • Nihon University Itabashi Hospital

    tabashi City, Tokyo, 173-8610

  • Medical Corporation Jitai kai Tachikawa Dermatology Clinic

    Tachikawa, Tokyo, 190-0023

  • Tokyo Medical University Hospital

    Tokyo, Shinjuku-Ku, 160-0023

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505

  • Yokohama City University Hospital

    Yokohama, Kanagawa-shi, 236-0004

Other trials in Japan

Czechia15 sites

  • Pratia Brno

    Brno, 602 00

  • Lékárna Pod Kaňkem

    Kutná Hora, 284 01

  • Dermamedica

    Náchod, Hradec Králové Region, 547 01

  • Nemocnice Novy Jicin

    Nový Jičín, 74101

  • Dermskin sro

    Olomouc, 77900

  • Vesalion s.r.o

    Ostrava, Moravian Silesian, 70200

  • CCR Ostrava

    Ostrava, 70200

  • Pratia Pardubice as

    Pardubice, 530 02

  • Fakultni nemocnice Plzen Dermatovenerologicka klinika

    Pilsen, 301 00

  • Sanatorium Profesora Arenbergera

    Prague, Prague, 1 110 00

  • Clintrial sro

    Prague, Prague, 100 00

  • Fakultni Nemocnice Kralovske Vinohrady FNKV Dermatovenerologicka Klinika

    Prague, 10034

  • Pratia Prague

    Prague, 101 00

  • Praglandia

    Prague, 15000

  • Dermatologicka ambulance Svitavy

    Svitavy, 568 02

Other trials in Czechia

Hungary8 sites

  • DermaMed Research Kf

    Békés, Oroshaza, 5900

  • UNO Medical Trials Kft.

    Budapest, 1152

  • Bőrgyógyászati Klinika, Debreceni Egyetem Orvos - és Egészségtudományi Centrum

    Debrecen, Hajdú-Bihar, 4032

  • Orvostudomanyi Kutato es Fejleszto Kft

    Debrecen, 4027

  • DERMA B Kft

    Debrecen, 4031

  • Bacs Kiskun County Teaching Hospital

    Kecskemét, Bács-Kiskun county, 6000

  • Allergo-Derm Bakos Kft

    Szolnok, JN, 5000

  • Medmare Bt

    Veszprém, 8200

Other trials in Hungary

Latvia7 sites

  • Semigallia Ltd

    Kuldīga, Kuldigas, LV3301

  • Riga 1st Hospital

    Riga, Riga, LV1001

  • SIA Veseliba un estetika

    Riga, Riga, LV1009

  • Med Art clinic

    Riga, LV1003

  • Veselibas Centrs 4

    Riga, LV1003

  • Veselibas Centrs 4 Filiale Dermatologijas Klinika

    Riga, LV1013

  • Smite Aija medical practice in dermatology venereology

    Talsi, Talsi, LV3201

Other trials in Latvia

Spain7 sites

  • Hospital Clínico Universitario de Santiago de Compostela

    A Coruña, Santiago de Compostela, 15706

  • University General Hospital Dr Balmis

    Alicante, Alicante, 3010

  • Hospital del Mar

    Barcelona, Barcelona, 8003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital Germans Trias i Pujol

    Barcelona, 8916

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Hospital de Manises

    Manises, 46940

Other trials in Spain

South Korea6 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 14068

  • Chosun Universtiy Hospital

    Gwangju, Dong-gu, 61453

  • Pusan National University Hospital

    Seogu, Busan, 49241

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 3080

  • Konkuk University Medical Center

    Seoul, 5030

Other trials in South Korea

Bulgaria5 sites

  • Multiprofile Hospital for Active Treatment Dr Tota Venkova

    Gabrovo, 5300

  • Medikal Center Kordis

    Pleven, 5800

  • Skin and Venereal Diseases Center EOOD

    Sofia, 1404

  • DCC Aleksandrovka

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment Alexandrovska

    Sofia, 1431

Other trials in Bulgaria

Australia4 sites

  • North Eastern Health Specialists

    Campbelltown, South Australia, 5074

  • Skin Health Institute

    Carlton, Victoria, 3053

  • Sinclair Dermatology

    East Melbourne, Victoria, 3002

  • Premier Specialist

    Kogarah, New South Wales, 2217

Other trials in Australia

Estonia4 sites

  • Innomedica

    Tallinn, Harju, 10117

  • Center for Clinical and Basic Research AS

    Tallinn, 10128

  • Tartu University Hospital

    Tartu, Tartu, 50417

  • Kliiniliste Uuringute Keskus OU

    Tartu, 50106

Other trials in Estonia

Puerto Rico4 sites

  • Centro Reumatologico de Cagus

    Caguas, Puerto Rico, 00725

  • Ponce Medical School Foundation Inc

    Ponce, Puerto Rico, 00716

  • Clinical Research Puerto Rico

    San Juan, Puerto Rico, 00909

  • GCM Medical Group PSC Hato Rey Site

    San Juan, 00917

Other trials in Puerto Rico

Portugal3 sites

  • Hospital da Senhora da Oliveira

    Guimarães, Braga District, 4835-044

  • Hospital CUF Descobertas

    Lisbon, Lisbon District, 1998-018

  • Unidade Local de Saude Santo Antonio Hospital de Santo Antonio

    Porto, 4099-001

Other trials in Portugal

France2 sites

  • Centre Azur Nice

    Nice, Alpes Maritimes, 6000

  • CHU de Rouen

    Rouen, Essais Cliniques, 76031

Other trials in France

About this study

Official title: 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?
Read more

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.
Being tested
Open-Label Envudeucitinib, Blinded Envudeucitinib, Placebo
Keywords
Psoriasis, PASI, Safety, ESK-001
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open-Label EnvudeucitinibDrug

    Open-Label ESK-001

  • Blinded EnvudeucitinibDrug

    Blinded ESK-001 during Randomized Treatment Withdrawal Period

  • PlaceboDrug

    Placebo during Randomized Treatment Withdrawal Period

Study groups in NCT06846541
Study groupRoleWhat they receive
Open-Label ESK-001ExperimentalOpen-Label ESK-001 administered as an oral tablet
Receives: Drug: Open-Label Envudeucitinib
Blinded ESK-001ExperimentalBlinded ESK-001 administered as an oral tablet
Receives: Drug: Blinded Envudeucitinib
PlaceboPlacebo comparatorMatching placebo administered as an oral tablet
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Approximately 4 years

Secondary outcomes (10)

  1. 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

    Measured: 24, 48, 72, and 96 weeks

  2. 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

    Measured: 24, 48, 72, and 96 weeks

  3. 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

    Measured: 24, 48, 72, and 96 weeks

  4. 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

    Measured: 24, 48, 72, and 96 weeks

  5. 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

    Measured: 24, 48, 72, and 96 weeks

  6. 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

    Measured: 24, 48, 72, and 96 weeks

  7. 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

    Measured: Week 48

  8. 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

    Measured: Week 48

  9. 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

    Measured: Week 48

  10. 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)

    Measured: Week 24, Week 48, and Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2025
  2. Study start8 Jan 2025
  3. Primary completionNov 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,680 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06846541
Sponsor's protocol ID
ESK-001-018
Acronym
ONWARD3
Status last verified
Apr 2026
First submitted
27 Jan 2025
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: The Sponsor Alumis Inc. is a clinical-stage biopharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Open-Label Envudeucitinib and Blinded Envudeucitinib in people with Plaque Psoriasis and Psoriasis (PsO), run by Alumis Inc at 268 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 268 sites in United States, Poland, Canada, Germany, Japan and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the long-term safety and tolerability of ESK-001 throughout the duration of the study (time frame: Approximately 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06846541.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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ONWARD3 Clinical Trial NCT06846541 | AzTrials