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ACTIVE NOT RECRUITING
NCT06586112
PHASE3

A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis

Sponsor: Alumis Inc

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if ESK-001 works to treat moderate to severe plaque psoriasis. The main questions it aims to answer are: * Does ESK-001 reduce the severity of people's psoriasis? * How safe is ESK-001 in people with moderate to severe plaque psoriasis? The study includes 2 comparators: a placebo control (a 'dummy' tablet that does not contain the medicine ESK-001 but looks just like it) and an active control (apremilast, which is a medicine approved to treat psoriasis). People taking part in this study must be men or women aged at least 18 years and have had plaque psoriasis for at least 6 months, currently moderate to severe. Participants will: * take drug every day for 24 weeks. * visit the clinic for checkups and tests. * fill out questionnaires about their psoriasis, itch severity, and change in quality of life. * be assessed for health issues and side effects, physical examinations, vital signs, heart electrical activity measurements, and psychological health. * provide blood and urine samples.

Official title: A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (ONWARD1)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

840

Start Date

2024-07-25

Completion Date

2025-12

Last Updated

2025-12-09

Healthy Volunteers

No

Interventions

DRUG

ESK-001

ESK-001

DRUG

Apremilast

Apremilast

DRUG

Placebo

Placebo

Locations (158)

Alliance Dermatology

Phoenix, Arizona, United States

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Northwest Arkansas Clinical Trials Center (NWACTC), PLLC

Rogers, Arkansas, United States

Exalt Clinical Research

Chula Vista, California, United States

California Dermatology & Clinical Research Institute

Encinitas, California, United States

First OC Dermatology Research Inc

Fountain Valley, California, United States

Marvel Clinical Research, LLC

Huntington Beach, California, United States

Sunwise Clinical Research, LLC

Lafayette, California, United States

Wallace Medical Group Inc

Los Angeles, California, United States

Northridge Clinical Trials - Elite Clinical Network

Northridge, California, United States

Pasadena Clinical Trials

Pasadena, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Unison Clinical Trials/ Shahram Jacobs MD

Sherman Oaks, California, United States

Olive View - UCLA Education & Research Institute

Sylmar, California, United States

California Dermatology Institute - Thousand Oaks

Thousand Oaks, California, United States

Clearlyderm Dermatology - West Boca Raton

Boca Raton, Florida, United States

Driven Clinical Research

Coral Gables, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Glick Skin Institute - Margate

Margate, Florida, United States

San Marcus Research Clinic, Inc - Miami

Miami Lakes, Florida, United States

Savin Medical Group LLC

Miami Lakes, Florida, United States

Oceanic Research Group

North Miami Beach, Florida, United States

LENUS Research

Sweetwater, Florida, United States

Caban Skin Institute

Tampa, Florida, United States

ForCare Medical Center

Tampa, Florida, United States

Skin Care Physicians of Georgia - Warner Robins

Macon, Georgia, United States

MetroMed Clinical Trials

Chicago, Illinois, United States

Arlington Dermatology

Rolling Meadows, Illinois, United States

NorthShore Medical Group - Dermatology - Skokie

Skokie, Illinois, United States

Dundee Dermatology

West Dundee, Illinois, United States

Dawes Fretzin Clinical Research Group

Columbus, Indiana, United States

The South Bend Clinic

South Bend, Indiana, United States

Equity Medical - Bowling Green

Bowling Green, Kentucky, United States

Velocity Clinical Research at The Dermatology Clinic, Baton Rouge

Baton Rouge, Louisiana, United States

Tulane University School of Medicine

New Orleans, Louisiana, United States

MetroBoston Clinical Partners

Brighton, Massachusetts, United States

Cleaver Dermatology

Kirksville, Missouri, United States

OptiSkin

New York, New York, United States

The Ohio State University Wexner Medical Center (OSUWMC) - OSU Dermatology East - Columbus

Gahanna, Ohio, United States

Dermatologists of Southwestern Ohio, LLC

Mason, Ohio, United States

Unity Clinical Research (UCR)

Oklahoma City, Oklahoma, United States

Velocity Clinical Research, Medford

Medford, Oregon, United States

Oregon Medical Research Center

Portland, Oregon, United States

Paddington Testing Company Inc.

Philadelphia, Pennsylvania, United States

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, United States

Health Concepts

Rapid City, South Dakota, United States

Discover Dermatology, LLC d/b/a Goodlettsville Dermatology Research

Goodlettsville, Tennessee, United States

Discover Dermatology, LLC d/b/a Cumberland Skin Center for Clinical Research under Objective Health

Hermitage, Tennessee, United States

UT Health Houston Department of Dermatology

Bellaire, Texas, United States

Studies in Dermatology, LLC

Cypress, Texas, United States

Reveal Research Institute

Frisco, Texas, United States

Center for Clinical Studies - Texas Medical Center

Houston, Texas, United States

Austin Institute for Clinical Research - Houston

Houston, Texas, United States

University of Utah Health Care - Midvalley Health Center

Murray, Utah, United States

Frontier Dermatology

Mill Creek, Washington, United States

Premier Specialists

Kogarah, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

North Eastern Health Specialists (NEHS)

Campbelltown, South Australia, Australia

Skin Health Institute Inc.

Carlton, Victoria, Australia

Sinclair Dermatology

East Melbourne, Victoria, Australia

Multiprofile Hospital for Active Treatment Dr Tota Venkova

Gabrovo, Gabrovo, Bulgaria

Clineca

Stara Zagora, Stara Zagora, Bulgaria

Medikal Center Kordis

Pleven, Bulgaria

Skin and Venereal Diseases Center EOOD

Sofia, Bulgaria

Diagnostic Consultative Center Aleksandrovska EOOD

Sofia, Bulgaria

Rejuvenation Medical Group Edmonton Downtown

Edmonton, Alberta, Canada

Enverus Medical Research

Surrey, British Columbia, Canada

Dermatrials Research Inc.

Hamilton, Ontario, Canada

Centricity Research

London, Ontario, Canada

DermEffects

London, Ontario, Canada

Lynderm Research Inc.

Markham, Ontario, Canada

DermEdge Research

Mississauga, Ontario, Canada

Institute of Cosmetic & Laser Surgery

Oakville, Ontario, Canada

The Centre for Dermatology

Richmond Hill, Ontario, Canada

North York Research Inc.

Toronto, Ontario, Canada

Canadian Dermatology Centre

Toronto, Ontario, Canada

Dermatology on Bloor

Toronto, Ontario, Canada

Alliance Clinical Trials

Waterloo, Ontario, Canada

"Centre de Recherche Dermatologique du Quebec Metropolitain Inc."

Québec, Quebec, Canada

Dermatologie Sima Inc.

Verdun, Quebec, Canada

Fakultni nemocnice Plzen Dermatovenerologicka klinika

Pilsen, Bory, Czechia

Pratia Brno s.r.o.

Brno, Moravia, Czechia

Dermskin, s.r.o.

Olomouc, Moravia, Czechia

Kozni ambulance Kutna Hora, s.r.o.

Kutná Hora, Czechia

DERMAMEDICA, s.r.o.

Náchod, Czechia

Nemocnice Nový Jičín, A.S.

Nový Jičín, Czechia

CCR Ostrava, s.r.o.

Ostrava, Czechia

Vesalion sro

Ostrava, Czechia

Pratia Pardubice a.s.

Pardubice, Czechia

Clintrial s.r.o.

Prague, Czechia

Fakultni Nemocnice Kralovske Vinohrady FNKV Dermatovenerologicka Klinika

Prague, Czechia

Sanatorium Profesora Arenbergera

Prague, Czechia

Pratia Prague, s.r.o.

Prague, Czechia

Praglandia

Prague, Czechia

Dermatologicka ambulance - Svitavy

Svitavy, Czechia

MUDr Radka Neumannova

Svitavy, Czechia

Eberhard Karls Universitaet Tuebingen Universitaets Hautklinik Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Hautarztpraxis Dr. Mihaescu

Augsburg, Bavaria, Germany

Hautarztpraxis Mahlow

Mahlow, Brandenburg, Germany

Universitatsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, Germany

Hautarztpraxis an der Hase

Bramsche, Lower Saxony, Germany

Siteworks

Lohne, Lower Saxony, Germany

Klinikum Bielefeld

Bielefeld, North Rhine-Westphalia, Germany

Pro Derma

Dülmen, North Rhine-Westphalia, Germany

Intramedis CSS

Remscheid, North Rhine-Westphalia, Germany

Universitatsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Fukuoka University Hospital

Fukuoka, Fukuoka-shi, Japan

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan

Nihon University Itabashi Hospital

Tokyo, Itabashi-Ku, Japan

Saruwatari Dermatology Clinic

Kagoshima, Kagoshima-Shi, Japan

Kanto Rosai Hospital

Kanagawa, Kawasaki-shi, Japan

Nagoya City University Hospital

Aichi, Nagoya-shi, Japan

Okayama University Hospital

Okayama, Okayama-shi, Japan

Osaka Metropolitan University Hospital

Osaka, Osaka-shi, Japan

Nippon Life Hospital

Osaka, Osaka-Shi, Japan

National Hospital Organization Sagamihara National Hospital

Kanagawa, Sagamihara, Japan

Dermatology and Ophthalmology Kume Clinic

Osaka, Saka-Shi, Japan

Hokkaido University Hospital

Hokkaido, Sapporo-shi, Japan

Kindai University Hospital

Osaka, Sayama-Shi, Japan

Tokyo Medical University Hospital

Tokyo, Shinjuku-Ku, Japan

Osaka University Hospital

Osaka, Suita-shi, Japan

Medical Corporation Jitai kai Tachikawa Dermatology Clinic

Tokyo, Tachikawa-shi, Japan

Mie University Hospital

Mie, Tsu-shi, Japan

Yamaguchi University Hospital

Yamaguchi, Ube-shi, Japan

Yokohama City University Hospital

Kanagawa, Yokohama-shi, Japan

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Specjalistyczny Ośrodek Alergologiczno-Internistyczny "ALL-MED"

Krakow, Lesser Poland Voivodeship, Poland

Centrum Medyczne Synexus Wroclaw

Wroclaw, Lower Silesian Voivodeship, Poland

WroMedica

Wroclaw, Lower Silesian Voivodeship, Poland

Diamond Clinic

Krakow, Malopolska, Poland

MICS Medical Center Warsaw

Warsaw, Masovian Voivodeship, Poland

FutureMeds Warszawa Centrum

Warsaw, Masovian Voivodeship, Poland

High Med Przychodnia Specjalistyczna

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne Reuma Park

Warsaw, Masovian Voivodeship, Poland

RoyalDerm

Warsaw, Mazowiecke, Poland

ClinicMed Daniluk, Nowak Spolka Komandytowa

Bialystok, Podlaskie Voivodeship, Poland

AES Gdansk

Gdansk, Pomeranian Voivodeship, Poland

Derm Art Institute

Gdynia, Pomeranian Voivodeship, Poland

Centrum Medyczne Synexus Gdynia

Gdynia, Pomeranian Voivodeship, Poland

Centrum Medyczne Angelius Provita (Angelius Provita Medical Centre)

Katowice, Silesian Voivodeship, Poland

Laser Clinic

Szczecin, West Pomeranian Voivodeship, Poland

Centrum Badań Klinicznych PI House Sp. Z O.O.

Gdansk, Poland

Pratia Małopolskie Centrum Medyczne (MCM) Kraków

Krakow, Poland

Rheuma Medicus

Warsaw, Poland

Centrum Medyczne Synexus Warszawa

Warsaw, 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, Porto District, Portugal

Chosun Universtiy Hospital

Gwangju, Dong-gu, South Korea

Konkuk University Medical Center

Seoul, Gwangjin-gu, South Korea

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Pusan National University Hospital

Busan, South Korea

Kyung Hee University Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea