A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (ONWARD2)

Status: Active_not_recruiting
Location: See all (125) 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
Alabama
Total Skin and Beauty Dermatology Center, PC
Birmingham
Arizona
Chandler Clinical Trials
Chandler
Noble Clinical Research
Tucson
California
Zenith Research Inc.
Beverly Hills
Raoof MD
Encino
Long Beach Research Institute
Long Beach
Dermatology Research Associates
Los Angeles
Empire Clinical Research - Pomona
Pomona
Integrative Skin Science and Research
Sacramento
UC San Diego
San Diego
Southern California Clinical Research
Santa Ana
Clinical Science Institute Dermatology Institute
Santa Monica
Florida
FXM Clinical Research Ft. Lauderdale LLC
Fort Lauderdale
Direct Helpers Research Center (DHRC)
Hialeah
AppleMed Research Group under WCG
Miami
FAX Pharma Clinical Research Inc
Miami
FXM Clinical Research - Miami LLC
Miami
Las Mercedes Medical Research
Miami
FXM Clinical Research Miramar LLC
Miramar
Renstar Medical Research
Ocala
Indiana
DS Research of Southern Indiana
Clarksville
The Indiana Clinical Trials Center
Plainfield
Kentucky
DS Research of Kentucky
Louisville
Michigan
Michigan Center for Research Company
Clarkston
Henry Ford Medical Center - Farmington Road
Detroit
Revival Research Institute
Troy
Grekin Skin Institute
Warren
Minnesota
Associated Skin Care Specialists - Minnesota Clinical Study Center
New Brighton
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
Pioneer Clinical Research NY
New York
DermResearchCenter of New York
Stony Brook
Ohio
Optima Research Boardman
Boardman
Rhode Island
Clinical Partners LLC
Johnston
Texas
Modern Research Associates PLLC
Dallas
SMS Clinical Research
Mesquite
Progressive Clinical Research - San Antonio
San Antonio
Center for Clinical Studies (CCS) - Webster/Clear Lake Location
Webster
Utah
Jordan Valley Dermatology
South Jordan
Other Locations
Austria
Klinik Hietzing
Vienna
Canada
CCA Medical Research Corp
Ajax
SimcoDerm Medical and Surgical Dermatology Center
Barrie
Beacon Dermatology
Calgary
SKiN Health
Cobourg
Alberta DermaSurgery
Edmonton
VIDA Dermatology/VIDA Clinical Research
Edmonton
Guelph Dermatology Research
Guelph
Mediprobe Research
London
Innovaderm
Montreal
Clear Skin Dermatology
Newmarket
North Bay Dermatology Centre
North Bay
Rejuvination Dermatology Oakville
Oakville
CaRe Clinic Red Deer
Red Deer
SkinSense Medical Research
Saskatoon
Skincare Studio
St. John's
Toronto Research Centre
Toronto
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
Polyclinique de Courlancy
Reims
CHU de Rouen
Rouen
Germany
ISA - Interdisciplinary Study Association GmbH
Berlin
Hautarztpraxis Dr Niesmann and Dr Othlinghaus
Bochum
Rosenpark Research
Darmstadt
Klinische Forschung Dresden GmbH
Dresden
Praxis fur Dermatologie und Venerologie
Dresden
Universitatsklinikum Erlangen
Erlangen
MVZ DermaKiel GmbH
Kiel
Haut Ambulatorium Magdeburg
Magdeburg
Dermatologische Praxis Dres Quist
Mainz
Universitaetsklinikum Muenster
Münster
Klinikum Oldenburg
Oldenburg
KliFOs Klinische Forschung Osnabruck
Osnabrück
Klinische Forschung Schwerin GmbH
Schwerin
Hungary
DermaMed Research Kf
Békés
Uno Medical Trials Kft
Budapest
Borgyogyaszati Klinika Debreceni Egyetem Orvos es Egeszsegtudomenyi 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
Israel
Sheba Tel HaShomer Medical Centre
Ramat Gan
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
Specderm
Bialystok
Pratia Gdynia
Gdynia
Care Clinic Katowice
Katowice
Pratia Katowice
Katowice
Research Solutions
Katowice
Centrum Medyczne dr Rajzer Spolka Zoo
Krakow
FutureMeds Krakow
Krakow
Dermoklinika
Lodz
FutureMeds Lodz
Lodz
Luxderm
Lublin
Zanamed Medical Clinic Sp z o o
Lublin
Klinika Dermatologii Uniwersytecki Szpital Kliniczny im F Chopina
Rzeszów
RCMed Oddział Sochaczew
Sochaczew
Centrum Medyczne Evimed
Warsaw
Clinical Best Solutions
Warsaw
Klinika Ambroziak Dermatologia Kliniczna
Warsaw
MTZ Clinical Research Sp z o o
Warsaw
dermMedica
Wroclaw
Puerto Rico
Centro Reumatologico de Caguas
Caguas
Clinical Research Puerto Rico
Ponce
Ponce Medical School Foundation Inc
Ponce
GCM Medical Group PSC Hato Rey Site
San Juan
Spain
University General Hospital Dr Balmis
Alicante
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitario 12 de Octubre
Madrid
Hospital de Manises
Manises
Hospital Clínico Universitario de Santiago de Compostela
Santiago De Compostela
Hospital Universitario Virgen Macarena
Seville
Time Frame
Start Date: 2024-08-20
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