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

Status: Recruiting
Location: See all (249) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

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

• 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

Locations
United States
Alabama
Total Dermatology
RECRUITING
Birmingham
Arkansas
Northwest AR Clinical Trials Center PLLC
RECRUITING
Rogers
Arizona
Chandler Clinical Trials
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Chandler
Alliance Dermatology
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Pheonix
Scottsdale Clinical Trials
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Scottsdale
Noble Clinical Research
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Tucson
California
Zenith Research Inc.
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Beverly Hills
Exalt Clinical Research Inc
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Chula Vista
California Dermatology and Clinical Research Institute
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Encinitas
Raoof MD
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Encino
First OC Dermatology Research Inc
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Fountain Valley
Marvel Clinical Research LLC
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Huntington Beach
Long Beach Research Institute
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Long Beach
Dermatology Research Associates
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Los Angeles
Olive View UCLA Education and Research Institute
RECRUITING
Los Angeles
Wallace Medical Group Inc
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Los Angeles
Northridge Clinical Trials
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Northridge
Pasadena Clinical Trials
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Pasadena
Empire Clinical Research Pomona
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Pomona
Integrative Skin Science and Research
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Sacramento
Therapeutics Clinical Research
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San Diego
Southern California Clinical Research
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Santa Ana
Clinical Science Institute Dermatology Institute
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Santa Monica
Unison Clinical Trials
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Sherman Oaks
California Dermatology Institute Thousand Oaks
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Thousand Oaks
Sunwise Clinical Research LLC
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Walnut Creek
Florida
Clearlyderm Dermatology West Boca Raton
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Boca Raton
Driven Clinical Research
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Coral Gables
FXM Clinical Research Ft. Lauderdale LLC
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Fort Lauderdale
Direct Helpers Research Center
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Hialeah
Jacksonville Center for Clinical Research
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Jacksonville
Glick Skin Institute
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Margate
AppleMed Research Group
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Miami
FAX Pharma Clinical Research Inc
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Miami
FXM Clinical Research Miami LLC
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Miami
Las Mercedes Medical Research
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Miami
Procare Research Center
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Miami Gardens
San Marcus Research Clinic Inc - Miami
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Miami Lakes
Savin Medical Group LLC
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Miami Lakes
FXM Clinical Research Miramar LLC
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Miramar
Oceanic Research Group
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North Miami Beach
Renstar Medical Research
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Ocala
Lenus Research and Medical Group LLC
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Sweetwater
Advanced Clinical Research Institute
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Tampa
ForCare Medical Center
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Tampa
Illinois
Arlington Dermatology
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Rolling Meadows
NorthShore Medical Group Dermatology Skokie
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Skokie
Dundee Dermatology
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West Dundee
Indiana
DS Research of Southern Indiana
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Clarksville
Dawes Fretzin Clinical Research Group
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Columbus
The Indiana Clinical Trials Center
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Plainfield
The South Bend Clinic
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South Bend
Kentucky
Equity Medical
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Bowling Green
DS Research of Kentucky
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Louisville
Louisiana
Velocity Clinical Research
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Baton Rouge
Massachusetts
MetroBoston Clinical Partners
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Brighton
Michigan
Michigan Center for Research Company
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Clarkston
Henry Ford Medical Center Farmington
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Detroit
Revival Research Institute
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Troy
Grekin Skin Institute
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Warren
Minnesota
Associated Skin Care Specialists Minnesota Clinical Study Center
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New Brighton
Missouri
Cleaver Dermatology
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Kirksville
North Carolina
Asheville Clinical Trials
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Asheville
WDC Cosmetic and Research
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Wilmington
Nebraska
Schlessinger MD
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Omaha
Nevada
Las Vegas Clinical Trials
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Las Vegas
New York
NYC Health and Hospitals Elmhurst
RECRUITING
Elmhurst
Cameron Dermatology
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New York
OptiSkin
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New York
Pioneer Clinical Research NY
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New York
DermResearchCenter of New York
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Stony Brook
Ohio
Optima Research Boardman
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Boardman
The Ohio State University Wexner Medical Center OSUWMC OSU Dermatology East Columbus
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Gahanna
Dermatologists of Southwestern Ohio LLC
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Mason
Oklahoma
Unity Clinical Research UCR
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Oklahoma City
Oregon
Velocity Clinical Research
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Medford
Oregon Medical Research Center
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Portland
Pennsylvania
Paddington Testing Company Inc
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Philadelphia
Rhode Island
Clinical Partners LLC
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Johnston
Texas
Studies in Dermatology LLC
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Cypress
Modern Research Associates PLLC
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Dallas
Reveal Research Institute
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Frisco
Austin Institute for Clinical Research
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Houston
Center for Clinical Studies Texas Medical Center
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Houston
SMS Clinical Research
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Mesquite
Progressive Clinical Research San Antonio
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San Antonio
Center for Clinical Studies (CCS) - Webster/Clear Lake Location
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Webster
Utah
University of Utah Health Care Midvalley Health Center
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Murray
Jordan Valley Dermatology
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South Jordan
Washington
Frontier Dermatology
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Mill Creek
Other Locations
Australia
North Eastern Health Specialists
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Campbelltown
Skin Health Institute
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Carlton
Sinclair Dermatology
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East Melbourne
Premier Specialist
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Kogarah
Bulgaria
Multiprofile Hospital for Active Treatment Dr Tota Venkova
RECRUITING
Gabrovo
Medikal Center Kordis
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Pleven
DCC Aleksandrovka
RECRUITING
Sofia
Skin and Venereal Diseases Center EOOD
RECRUITING
Sofia
University Multiprofile Hospital for Active Treatment Alexandrovska
RECRUITING
Sofia
Canada
CCA Medical Research Corp
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Ajax
SimcoDerm Medical and Surgical Dermatology Center
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Barrie
SKiN Health
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Coburg
Alberta DermaSurgery
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Edmonton
Guelph Dermatology Research
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Guelph
Dermatrials Research Inc
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Hamilton
Centricity Research London
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London
Derm Effects
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London
Lynderm Research
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Markham
DermEdge Research Inc
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Mississauga
Innovaderm
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Montreal
Clear Skin Dermatology
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Newmarket
North Bay Dermatolgy Centre
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North Bay
Canadian Dermatology Centre
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North York
Institute of Cosmetic and Laser Surgery
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Oakville
Rejuvenation Dermatology - Oakville
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Oakville
Centre of Research in Dermatology Quebec CRDQ
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Québec
CaRe Clinic Red Deer
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Red Deer
The Centre for Dermatology
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Richmond Hill
Skinsense Medical Research
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Saskatoon
Enverus Medical
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Surrey
Dermatology on Bloor
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Toronto
North York Research Inc
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Toronto
Toronto Research Centre
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Toronto
Dermatologie Sima Inc
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Verdun
Alliance Clinical Trials Inc
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Waterloo
XLR8 Medical Research
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Windsor
Estonia
Center for Clinical and Basic Research AS
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Tallinn
Innomedica
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Tallinn
Kliiniliste Uuringute Keskus OU
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Tartu
Tartu University Hospital
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Tartu
France
Centre Azur Nice
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Nice
CHU de Rouen
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Rouen
Germany
Hautarztpraxis Dr Mihaescu
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Augsburg
Fachklinik Bad Bentheim
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Bad Bentheim
ISA - Interdisciplinary Study Association GmbH
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Berlin
Klinikum Bielefeld
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Bielefeld
Hautarztpraxis Dr Niesmann and Dr Othlinghaus
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Bochum
Hautarztpraxis an der Hase
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Bramsche
Rosenpark Research
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Darmstadt
Klinische Forschung Dresden GmbH
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Dresden
Praxis fur Dermatologie und Venerologie
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Dresden
Universitatsklinikum Erlangen
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Erlangen
Universitatsklinikum Frankfurt
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Frankfurt Am Main
MVZ DermaKiel GmbH
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Kiel
Universitatsklinikum Schleswig Holstein
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Kiel
Universitatsklinikum Schleswig Holstein
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Lübeck
Haut Ambulatorium Magdeburg
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Magdeburg
Hautarztpraxis Mahlow
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Mahlow
Dermatologische Praxis Dres Quist
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Mainz
Universitaetsklinikum Muenster
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Münster
Klinikum Oldenburg
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Oldenburg
KliFOs Klinische Forschung Osnabruck
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Osnabrück
Intramedis CSS
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Remscheid
Klinische Forschung Schwerin GmbH
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Schwerin
Eberhard Karls Universitaet Tuebingen Universitaets Hautklinik Tuebingen
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Tübingen
Hungary
DermaMed Research Kf
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Békés
UNO Medical Trials Kft.
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Budapest
Bőrgyógyászati Klinika, Debreceni Egyetem Orvos - és Egészségtudományi Centrum
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Debrecen
DERMA B Kft
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Debrecen
Orvostudomanyi Kutato es Fejleszto Kft
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Debrecen
Bacs Kiskun County Teaching Hospital
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Kecskemét
Allergo-Derm Bakos Kft
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Szolnok
Medmare Bt
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Veszprém
Japan
Asahikawa Medical University Hospital
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Asahikawa
Fukuoka University Hospital
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Fukuoka
Hokkaido University Hospital
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Hokkaido
Tokyo Medical University Ibaraki Medical Center
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Ibaraki
Saruwatari Dermatology Clinic
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Kagoshima
Kanto Rosai Hospital
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Kanagawa
Nagoya City University Hospital
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Nagoya
Okayama University Hospital
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Okayama
Kindai University Hospital
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Osaka
Nippon Life Hospital
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Osaka
Osaka Metropolitan University Hospital
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Osaka
National Hospital Organization Sagamihara National Hospital
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Sagamihara
Dermatology and Ophthalmology Kume Clinic
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Sakai
Osaka University Hospital
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Suita
Nihon University Itabashi Hospital
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Tabashi City
Medical Corporation Jitai kai Tachikawa Dermatology Clinic
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Tachikawa
Tokyo Medical University Hospital
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Tokyo
Mie University Hospital
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Tsu
Yamaguchi University Hospital
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Ube
Yokohama City University Hospital
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Yokohama
Latvia
Semigallia Ltd
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Kuldīga
Med Art clinic
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Riga
Riga 1st Hospital
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Riga
SIA Veseliba un estetika
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Riga
Veselibas Centrs 4
RECRUITING
Riga
Veselibas Centrs 4 Filiale Dermatologijas Klinika
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Riga
Smite Aija medical practice in dermatology venereology
RECRUITING
Talsi
Poland
ClinicMed Daniluk Nowak SpK
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Bialystok
Centrum Medyczne Pratia Bydgoszcz
RECRUITING
Bydgoszcz
AES Gdansk
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Gdansk
Centrum Badan Klinicznych PI House
RECRUITING
Gdansk
Derm Art Institute
RECRUITING
Gdynia
Pratia Gdynia
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Gdynia
Synexus Sp zo o Oddzial w Gdyni
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Gdynia
Care Clinic Katowice
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Katowice
Centrum Medyczne Angelius Provita
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Katowice
Pratia Katowice
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Katowice
Research Solutions
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Katowice
Centrum Medyczne All Med Badania Kliniczne
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Krakow
Centrum Medyczne dr Rajzer spolka zoo
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Krakow
Diamond Clinic
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Krakow
Krakowskie Centrum Medyczne
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Krakow
Pratia MCM Krakow
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Krakow
Dermoklinika
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Lodz
FutureMeds Lodz
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Lodz
Luxderm
RECRUITING
Lublin
Zanamed Medical Clinic Sp z o o
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Lublin
Specderm
RECRUITING
Podlaski
Klinika Dermatologii Uniwersytecki Szpital Kliniczny im F Chopina
RECRUITING
Rzeszów
Velocity Clinical Research Skierniewice
RECRUITING
Skierniewice
RCMed Oddział Sochaczew
RECRUITING
Sochaczew
Laser Clinic
RECRUITING
Szczecin
Centrum Medyczne Evimed
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Warsaw
Centrum Medyczne Reuma Park
RECRUITING
Warsaw
Centrum Medyczne Synexus Warszawa
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Warsaw
Clinical Best Solutions
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Warsaw
FutureMeds Warszawa Centrum
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Warsaw
High Med Przychodnia Specjalistyczna
RECRUITING
Warsaw
Klinika Ambroziak Dermatologia Kliniczna
RECRUITING
Warsaw
MICS Medical Center Warsaw
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Warsaw
MTZ Clinical Research Sp z o o
RECRUITING
Warsaw
Rheuma Medicus
RECRUITING
Warsaw
RoyalDerm
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Warsaw
dermMedica
RECRUITING
Wroclaw
Synexus Centrum Medyczne Osteomed Wroclaw
RECRUITING
Wroclaw
WroMedica
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Wroclaw
Portugal
Hospital da Senhora da Oliveira
RECRUITING
Guimarães
Hospital CUF Descobertas
RECRUITING
Lisbon
Unidade Local de Saude Santo Antonio Hospital de Santo Antonio
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Porto
Puerto Rico
Centro Reumatologico de Cagus
RECRUITING
Caguas
Ponce Medical School Foundation Inc
RECRUITING
Ponce
Clinical Research Puerto Rico
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San Juan
GCM Medical Group PSC Hato Rey Site
RECRUITING
San Juan
Republic of Korea
Hallym University Sacred Heart Hospital
RECRUITING
Anyang-si
Chosun Universtiy Hospital
RECRUITING
Gwangju
Pusan National University Hospital
RECRUITING
Seogu
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Konkuk University Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Spain
Hospital Clínico Universitario de Santiago de Compostela
RECRUITING
A Coruña
University General Hospital Dr Balmis
RECRUITING
Alicante
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Hospital Germans Trias i Pujol
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Barcelona
Hospital Universitario La Paz
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Madrid
Hospital de Manises
RECRUITING
Manises
Contact Information
Primary
Alumis Information
clinicaltrials@alumis.com
(650) 231-6625
Time Frame
Start Date: 2025-01-08
Estimated Completion Date: 2028-11
Participants
Target number of participants: 1680
Treatments
Experimental: Open-Label ESK-001
Open-Label ESK-001 administered as an oral tablet
Experimental: Blinded ESK-001
Blinded ESK-001 administered as an oral tablet
Placebo_comparator: Placebo
Matching placebo administered as an oral tablet
Related Therapeutic Areas
Sponsors
Leads: Alumis Inc

This content was sourced from clinicaltrials.gov

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