Psoriasis Clinical Trials

Find Psoriasis Clinical Trials Near You

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: Active_not_recruiting
Location: See all (253) 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
Birmingham
Arkansas
Northwest AR Clinical Trials Center PLLC
Rogers
Arizona
Chandler Clinical Trials
Chandler
Alliance Dermatology
Pheonix
Scottsdale Clinical Trials
Scottsdale
Noble Clinical Research
Tucson
California
Zenith Research Inc.
Beverly Hills
Exalt Clinical Research Inc
Chula Vista
California Dermatology and Clinical Research Institute
Encinitas
Raoof MD
Encino
First OC Dermatology Research Inc
Fountain Valley
Marvel Clinical Research LLC
Huntington Beach
Long Beach Research Institute
Long Beach
Dermatology Research Associates
Los Angeles
Olive View UCLA Education and Research Institute
Los Angeles
Wallace Medical Group Inc
Los Angeles
Northridge Clinical Trials
Northridge
Pasadena Clinical Trials
Pasadena
Empire Clinical Research Pomona
Pomona
Integrative Skin Science and Research
Sacramento
Therapeutics Clinical Research
San Diego
Southern California Clinical Research
Santa Ana
Clinical Science Institute Dermatology Institute
Santa Monica
Unison Clinical Trials
Sherman Oaks
California Dermatology Institute Thousand Oaks
Thousand Oaks
Sunwise Clinical Research LLC
Walnut Creek
Florida
Clearlyderm Dermatology West Boca Raton
Boca Raton
Driven Clinical Research
Coral Gables
FXM Clinical Research Ft. Lauderdale LLC
Fort Lauderdale
Direct Helpers Research Center
Hialeah
Jacksonville Center for Clinical Research
Jacksonville
Glick Skin Institute
Margate
AppleMed Research Group
Miami
FAX Pharma Clinical Research Inc
Miami
FXM Clinical Research Miami LLC
Miami
Las Mercedes Medical Research
Miami
Procare Research Center
Miami Gardens
San Marcus Research Clinic Inc - Miami
Miami Lakes
Savin Medical Group LLC
Miami Lakes
FXM Clinical Research Miramar LLC
Miramar
Oceanic Research Group
North Miami Beach
Renstar Medical Research
Ocala
Lenus Research and Medical Group LLC
Sweetwater
Advanced Clinical Research Institute
Tampa
ForCare Medical Center
Tampa
Illinois
Arlington Dermatology
Rolling Meadows
NorthShore Medical Group Dermatology Skokie
Skokie
Dundee Dermatology
West Dundee
Indiana
DS Research of Southern Indiana
Clarksville
Dawes Fretzin Clinical Research Group
Columbus
The Indiana Clinical Trials Center
Plainfield
The South Bend Clinic
South Bend
Kentucky
Equity Medical
Bowling Green
DS Research of Kentucky
Louisville
Louisiana
Velocity Clinical Research
Baton Rouge
Tulane University School of Medicine
New Orleans
Massachusetts
MetroBoston Clinical Partners
Brighton
Michigan
Michigan Center for Research Company
Clarkston
Henry Ford Medical Center Farmington
Detroit
Revival Research Institute
Troy
Grekin Skin Institute
Warren
Minnesota
Associated Skin Care Specialists Minnesota Clinical Study Center
New Brighton
Missouri
Cleaver Dermatology
Kirksville
North Carolina
Asheville Clinical Trials
Asheville
WDC Cosmetic and Research
Wilmington
Nebraska
Schlessinger MD
Omaha
Nevada
Las Vegas Clinical Trials
Las Vegas
New York
NYC Health and Hospitals Elmhurst
Elmhurst
Cameron Dermatology
New York
OptiSkin
New York
Pioneer Clinical Research NY
New York
DermResearchCenter of New York
Stony Brook
Ohio
Optima Research Boardman
Boardman
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
Oregon Medical Research Center
Portland
Pennsylvania
Paddington Testing Company Inc
Philadelphia
UPMC Department of Dermatology
Pittsburgh
Rhode Island
Clinical Partners LLC
Johnston
Texas
Studies in Dermatology LLC
Cypress
Modern Research Associates PLLC
Dallas
Reveal Research Institute
Frisco
Austin Institute for Clinical Research
Houston
Center for Clinical Studies Texas Medical Center
Houston
SMS Clinical Research
Mesquite
Progressive Clinical Research San Antonio
San Antonio
Center for Clinical Studies (CCS) - Webster/Clear Lake Location
Webster
Utah
University of Utah Health Care Midvalley Health Center
Murray
Jordan Valley Dermatology
South Jordan
Washington
Frontier Dermatology
Mill Creek
Other Locations
Australia
North Eastern Health Specialists
Campbelltown
Skin Health Institute
Carlton
Sinclair Dermatology
East Melbourne
Premier Specialist
Kogarah
Bulgaria
Multiprofile Hospital for Active Treatment Dr Tota Venkova
Gabrovo
Medikal Center Kordis
Pleven
DCC Aleksandrovka
Sofia
Skin and Venereal Diseases Center EOOD
Sofia
University Multiprofile Hospital for Active Treatment Alexandrovska
Sofia
Canada
CCA Medical Research Corp
Ajax
SimcoDerm Medical and Surgical Dermatology Center
Barrie
SKiN Health
Coburg
Alberta DermaSurgery
Edmonton
Rejuvenation Medical Group Edmonton Downtown
Edmonton
VIDA Dermatology/VIDA Clinical Research
Edmonton
Guelph Dermatology Research
Guelph
Dermatrials Research Inc
Hamilton
Centricity Research London
London
Derm Effects
London
Lynderm Research
Markham
DermEdge Research Inc
Mississauga
Innovaderm
Montreal
Clear Skin Dermatology
Newmarket
North Bay Dermatolgy Centre
North Bay
Canadian Dermatology Centre
North York
Institute of Cosmetic and Laser Surgery
Oakville
Rejuvenation Dermatology - Oakville
Oakville
Centre of Research in Dermatology Quebec CRDQ
Québec
CaRe Clinic Red Deer
Red Deer
The Centre for Dermatology
Richmond Hill
Skinsense Medical Research
Saskatoon
Enverus Medical
Surrey
Dermatology on Bloor
Toronto
North York Research Inc
Toronto
Toronto Research Centre
Toronto
Dermatologie Sima Inc
Verdun
Alliance Clinical Trials Inc
Waterloo
XLR8 Medical Research
Windsor
Estonia
Center for Clinical and Basic Research AS
Tallinn
Innomedica
Tallinn
Kliiniliste Uuringute Keskus OU
Tartu
Tartu University Hospital
Tartu
France
Centre Azur Nice
Nice
CHU de Rouen
Rouen
Germany
Hautarztpraxis Dr Mihaescu
Augsburg
Fachklinik Bad Bentheim
Bad Bentheim
ISA - Interdisciplinary Study Association GmbH
Berlin
Klinikum Bielefeld
Bielefeld
Hautarztpraxis Dr Niesmann and Dr Othlinghaus
Bochum
Hautarztpraxis an der Hase
Bramsche
Rosenpark Research
Darmstadt
Klinische Forschung Dresden GmbH
Dresden
Praxis fur Dermatologie und Venerologie
Dresden
Universitatsklinikum Erlangen
Erlangen
Universitatsklinikum Frankfurt
Frankfurt Am Main
MVZ DermaKiel GmbH
Kiel
Universitatsklinikum Schleswig Holstein
Kiel
Universitatsklinikum Schleswig Holstein
Lübeck
Haut Ambulatorium Magdeburg
Magdeburg
Hautarztpraxis Mahlow
Mahlow
Dermatologische Praxis Dres Quist
Mainz
Universitaetsklinikum Muenster
Münster
Klinikum Oldenburg
Oldenburg
KliFOs Klinische Forschung Osnabruck
Osnabrück
Intramedis CSS
Remscheid
Klinische Forschung Schwerin GmbH
Schwerin
Eberhard Karls Universitaet Tuebingen Universitaets Hautklinik Tuebingen
Tübingen
Hungary
DermaMed Research Kf
Békés
UNO Medical Trials Kft.
Budapest
Bőrgyógyászati Klinika, Debreceni Egyetem Orvos - és Egészségtudományi Centrum
Debrecen
DERMA B Kft
Debrecen
Orvostudomanyi Kutato es Fejleszto Kft
Debrecen
Bacs Kiskun County Teaching Hospital
Kecskemét
Allergo-Derm Bakos Kft
Szolnok
Medmare Bt
Veszprém
Japan
Asahikawa Medical University Hospital
Asahikawa
Fukuoka University Hospital
Fukuoka
Hokkaido University Hospital
Hokkaido
Tokyo Medical University Ibaraki Medical Center
Ibaraki
Saruwatari Dermatology Clinic
Kagoshima
Kanto Rosai Hospital
Kanagawa
Nagoya City University Hospital
Nagoya
Okayama University Hospital
Okayama
Kindai University Hospital
Osaka
Nippon Life Hospital
Osaka
Osaka Metropolitan University Hospital
Osaka
National Hospital Organization Sagamihara National Hospital
Sagamihara
Dermatology and Ophthalmology Kume Clinic
Sakai
Osaka University Hospital
Suita
Nihon University Itabashi Hospital
Tabashi City
Medical Corporation Jitai kai Tachikawa Dermatology Clinic
Tachikawa
Tokyo Medical University Hospital
Tokyo
Mie University Hospital
Tsu
Yamaguchi University Hospital
Ube
Yokohama City University Hospital
Yokohama
Latvia
Semigallia Ltd
Kuldīga
Med Art clinic
Riga
Riga 1st Hospital
Riga
SIA Veseliba un estetika
Riga
Veselibas Centrs 4
Riga
Veselibas Centrs 4 Filiale Dermatologijas Klinika
Riga
Smite Aija medical practice in dermatology venereology
Talsi
Poland
ClinicMed Daniluk Nowak SpK
Bialystok
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz
AES Gdansk
Gdansk
Centrum Badan Klinicznych PI House
Gdansk
Derm Art Institute
Gdynia
Pratia Gdynia
Gdynia
Synexus Sp zo o Oddzial w Gdyni
Gdynia
Care Clinic Katowice
Katowice
Centrum Medyczne Angelius Provita
Katowice
Pratia Katowice
Katowice
Research Solutions
Katowice
Centrum Medyczne All Med Badania Kliniczne
Krakow
Centrum Medyczne dr Rajzer spolka zoo
Krakow
Diamond Clinic
Krakow
Krakowskie Centrum Medyczne
Krakow
Pratia MCM Krakow
Krakow
Dermoklinika
Lodz
FutureMeds Lodz
Lodz
Luxderm
Lublin
Zanamed Medical Clinic Sp z o o
Lublin
Specderm
Podlaski
Klinika Dermatologii Uniwersytecki Szpital Kliniczny im F Chopina
Rzeszów
Velocity Clinical Research Skierniewice
Skierniewice
RCMed Oddział Sochaczew
Sochaczew
Laser Clinic
Szczecin
Centrum Medyczne Evimed
Warsaw
Centrum Medyczne Reuma Park
Warsaw
Centrum Medyczne Synexus Warszawa
Warsaw
Clinical Best Solutions
Warsaw
FutureMeds Warszawa Centrum
Warsaw
High Med Przychodnia Specjalistyczna
Warsaw
Klinika Ambroziak Dermatologia Kliniczna
Warsaw
MICS Medical Center Warsaw
Warsaw
MTZ Clinical Research Sp z o o
Warsaw
Rheuma Medicus
Warsaw
RoyalDerm
Warsaw
dermMedica
Wroclaw
Synexus Centrum Medyczne Osteomed 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
Puerto Rico
Centro Reumatologico de Cagus
Caguas
Ponce Medical School Foundation Inc
Ponce
Clinical Research Puerto Rico
San Juan
GCM Medical Group PSC Hato Rey Site
San Juan
Republic of Korea
Hallym University Sacred Heart Hospital
Anyang-si
Chosun Universtiy Hospital
Gwangju
Pusan National University Hospital
Seogu
Seoul National University Bundang Hospital
Seongnam-si
Konkuk University Medical Center
Seoul
Seoul National University Hospital
Seoul
Spain
Hospital Clínico Universitario de Santiago de Compostela
A Coruña
University General Hospital Dr Balmis
Alicante
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital del Mar
Barcelona
Hospital Germans Trias i Pujol
Barcelona
Hospital Universitario La Paz
Madrid
Hospital de Manises
Manises
Time Frame
Start Date: 2025-01-08
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