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)

Status: Active_not_recruiting
Location: See all (142) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Males or females, age ≥18 years

• Diagnosis of plaque psoriasis for ≥6 months

• Plaques covering ≥10% of BSA

• PASI ≥12

• sPGA ≥3

• Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception

Locations
United States
Arkansas
Northwest Arkansas Clinical Trials Center (NWACTC), PLLC
Rogers
Arizona
Alliance Dermatology
Phoenix
Scottsdale Clinical Trials
Scottsdale
California
Exalt Clinical Research
Chula Vista
California Dermatology & Clinical Research Institute
Encinitas
First OC Dermatology Research Inc
Fountain Valley
Marvel Clinical Research, LLC
Huntington Beach
Sunwise Clinical Research, LLC
Lafayette
Wallace Medical Group Inc
Los Angeles
Northridge Clinical Trials - Elite Clinical Network
Northridge
Pasadena Clinical Trials
Pasadena
Therapeutics Clinical Research
San Diego
Unison Clinical Trials/ Shahram Jacobs MD
Sherman Oaks
Olive View - UCLA Education & Research Institute
Sylmar
California Dermatology Institute - Thousand Oaks
Thousand Oaks
Florida
Clearlyderm Dermatology - West Boca Raton
Boca Raton
Driven Clinical Research
Coral Gables
Jacksonville Center for Clinical Research
Jacksonville
Glick Skin Institute - Margate
Margate
San Marcus Research Clinic, Inc - Miami
Miami Lakes
Savin Medical Group LLC
Miami Lakes
Oceanic Research Group
North Miami Beach
LENUS Research
Sweetwater
Caban Skin Institute
Tampa
ForCare Medical Center
Tampa
Georgia
Skin Care Physicians of Georgia - Warner Robins
Macon
Illinois
MetroMed Clinical Trials
Chicago
Arlington Dermatology
Rolling Meadows
NorthShore Medical Group - Dermatology - Skokie
Skokie
Dundee Dermatology
West Dundee
Indiana
Dawes Fretzin Clinical Research Group
Columbus
The South Bend Clinic
South Bend
Kentucky
Equity Medical - Bowling Green
Bowling Green
Louisiana
Velocity Clinical Research at The Dermatology Clinic, Baton Rouge
Baton Rouge
Tulane University School of Medicine
New Orleans
Massachusetts
MetroBoston Clinical Partners
Brighton
Missouri
Cleaver Dermatology
Kirksville
New York
OptiSkin
New York
Ohio
The Ohio State University Wexner Medical Center (OSUWMC) - OSU Dermatology East - Columbus
Gahanna
Dermatologists of Southwestern Ohio, LLC
Mason
Oklahoma
Unity Clinical Research (UCR)
Oklahoma City
Oregon
Velocity Clinical Research, Medford
Medford
Oregon Medical Research Center
Portland
Pennsylvania
Paddington Testing Company Inc.
Philadelphia
UPMC Department of Dermatology
Pittsburgh
South Dakota
Health Concepts
Rapid City
Tennessee
Discover Dermatology, LLC d/b/a Goodlettsville Dermatology Research
Goodlettsville
Discover Dermatology, LLC d/b/a Cumberland Skin Center for Clinical Research under Objective Health
Hermitage
Texas
UT Health Houston Department of Dermatology
Bellaire
Studies in Dermatology, LLC
Cypress
Reveal Research Institute
Frisco
Austin Institute for Clinical Research - Houston
Houston
Center for Clinical Studies - Texas Medical Center
Houston
Utah
University of Utah Health Care - Midvalley Health Center
Murray
Washington
Frontier Dermatology
Mill Creek
Other Locations
Australia
North Eastern Health Specialists (NEHS)
Campbelltown
Skin Health Institute Inc.
Carlton
Sinclair Dermatology
East Melbourne
Premier Specialists
Kogarah
Westmead Hospital
Westmead
Bulgaria
Multiprofile Hospital for Active Treatment Dr Tota Venkova
Gabrovo
Medikal Center Kordis
Pleven
Diagnostic Consultative Center Aleksandrovska EOOD
Sofia
Skin and Venereal Diseases Center EOOD
Sofia
Clineca
Stara Zagora
Canada
Rejuvenation Medical Group Edmonton Downtown
Edmonton
Dermatrials Research Inc.
Hamilton
Centricity Research
London
DermEffects
London
Lynderm Research Inc.
Markham
DermEdge Research
Mississauga
Institute of Cosmetic & Laser Surgery
Oakville
Centre de Recherche Dermatologique du Quebec Metropolitain Inc.
Québec
The Centre for Dermatology
Richmond Hill
Enverus Medical Research
Surrey
Canadian Dermatology Centre
Toronto
Dermatology on Bloor
Toronto
North York Research Inc.
Toronto
Dermatologie Sima Inc.
Verdun
Alliance Clinical Trials
Waterloo
Germany
Hautarztpraxis Dr. Mihaescu
Augsburg
Fachklinik Bad Bentheim
Bad Bentheim
Klinikum Bielefeld
Bielefeld
Hautarztpraxis an der Hase
Bramsche
Pro Derma
Dülmen
Universitatsklinikum Frankfurt
Frankfurt Am Main
Universitatsklinikum Schleswig-Holstein
Kiel
Siteworks
Lohne
Hautarztpraxis Mahlow
Mahlow
Intramedis CSS
Remscheid
Eberhard Karls Universitaet Tuebingen Universitaets Hautklinik Tuebingen
Tübingen
Japan
Nagoya City University Hospital
Aichi
Asahikawa Medical University Hospital
Asahikawa
Fukuoka University Hospital
Fukuoka
Hokkaido University Hospital
Hokkaido
Saruwatari Dermatology Clinic
Kagoshima
Kanto Rosai Hospital
Kanagawa
National Hospital Organization Sagamihara National Hospital
Kanagawa
Yokohama City University Hospital
Kanagawa
Mie University Hospital
Mie
Okayama University Hospital
Okayama
Dermatology and Ophthalmology Kume Clinic
Osaka
Kindai University Hospital
Osaka
Nippon Life Hospital
Osaka
Osaka Metropolitan University Hospital
Osaka
Osaka University Hospital
Osaka
Medical Corporation Jitai kai Tachikawa Dermatology Clinic
Tokyo
Nihon University Itabashi Hospital
Tokyo
Tokyo Medical University Hospital
Tokyo
Yamaguchi University Hospital
Yamaguchi
Poland
ClinicMed Daniluk, Nowak Spolka Komandytowa
Bialystok
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz
AES Gdansk
Gdansk
Centrum Badań Klinicznych PI House Sp. Z O.O.
Gdansk
Centrum Medyczne Synexus Gdynia
Gdynia
Derm Art Institute
Gdynia
Centrum Medyczne Angelius Provita (Angelius Provita Medical Centre)
Katowice
Diamond Clinic
Krakow
Pratia Małopolskie Centrum Medyczne (MCM) Kraków
Krakow
Specjalistyczny Ośrodek Alergologiczno-Internistyczny ALL-MED
Krakow
Velocity Clinical Research, Skierniewice
Skierniewice
Laser Clinic
Szczecin
Centrum Medyczne Reuma Park
Warsaw
Centrum Medyczne Synexus Warszawa
Warsaw
FutureMeds Warszawa Centrum
Warsaw
High Med Przychodnia Specjalistyczna
Warsaw
MICS Medical Center Warsaw
Warsaw
Rheuma Medicus
Warsaw
RoyalDerm
Warsaw
Centrum Medyczne Synexus Wroclaw
Wroclaw
WroMedica
Wroclaw
Portugal
Hospital da Senhora da Oliveira
Guimarães
Hospital CUF Descobertas
Lisbon
Unidade Local de Saude Santo Antonio Hospital de Santo Antonio
Porto
Republic of Korea
Hallym University Sacred Heart Hospital
Anyang-si
Pusan National University Hospital
Busan
Chosun Universtiy Hospital
Gwangju
CHA Bundang Medical Center
Seongnam-si
Seoul National University Bundang Hospital
Seongnam-si
Konkuk University Medical Center
Seoul
Kyung Hee University Medical Center
Seoul
Seoul National University Hospital
Seoul
Time Frame
Start Date: 2024-07-25
Completion Date: 2025-12
Participants
Target number of participants: 840
Treatments
Experimental: ESK-001
ESK-001 administered as an oral tablet
Placebo_comparator: Placebo
Matching oral placebo
Active_comparator: Apremilast
Apremilast administered as an oral capsule
Related Therapeutic Areas
Sponsors
Leads: Alumis Inc

This content was sourced from clinicaltrials.gov