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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)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
Chandler Clinical Trials
Chandler, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Zenith Research Inc.
Beverly Hills, California, United States
Raoof MD
Encino, California, United States
Long Beach Research Institute
Long Beach, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Empire Clinical Research - Pomona
Pomona, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
UC San Diego
San Diego, California, United States
Start Date
August 20, 2024
Primary Completion Date
September 23, 2025
Completion Date
December 1, 2025
Last Updated
December 9, 2025
840
ESTIMATED participants
ESK-001
DRUG
Placebo
DRUG
Apremilast
DRUG
Lead Sponsor
Alumis Inc
NCT07116967
NCT07250802
NCT07449702
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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