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ACTIVE NOT RECRUITING

NCT06846541

PHASE3

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

Sponsor: Alumis Inc

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1680

Start Date

2025-01-08

Completion Date

2028-11

Last Updated

2026-02-25

Healthy Volunteers

Conditions

Plaque Psoriasis Psoriasis (PsO)Psoriasis Moderate Psoriasis Severe Psoriasis

Interventions

DRUG

Open-Label ESK-001

DRUG

Blinded ESK-001

Blinded ESK-001 during Randomized Treatment Withdrawal Period

DRUG

Placebo

Placebo during Randomized Treatment Withdrawal Period

Locations (268)

Total Dermatology

Birmingham, Alabama, United States

Chandler Clinical Trials

Chandler, Arizona, United States

Alliance Dermatology

Pheonix, Arizona, United States

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Noble Clinical Research

Tucson, Arizona, United States

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

Los Angeles, California, United States

Wallace Medical Group Inc

Los Angeles, California, United States

Northridge Clinical Trials

Northridge, California, United States

Pasadena Clinical Trials

Pasadena, California, United States

Empire Clinical Research Pomona

Pomona, California, United States

Integrative Skin Science and Research

Sacramento, California, United States

Therapeutics Clinical Research

San Diego, California, United States

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