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Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
Sponsor: Alumis Inc
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1680
Start Date
2025-01-08
Completion Date
2028-11
Last Updated
2026-04-13
Healthy Volunteers
No
Interventions
Open-Label Envudeucitinib
Open-Label ESK-001
Blinded Envudeucitinib
Blinded ESK-001 during Randomized Treatment Withdrawal Period
Placebo
Placebo during Randomized Treatment Withdrawal Period
Locations (268)
Total Dermatology
Birmingham, Alabama, United States
Chandler Clinical Trials
Chandler, Arizona, United States
Alliance Dermatology
Pheonix, Arizona, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Northwest AR Clinical Trials Center PLLC
Rogers, Arkansas, United States
Zenith Research Inc.
Beverly Hills, California, United States
Exalt Clinical Research Inc
Chula Vista, California, United States
California Dermatology and Clinical Research Institute
Encinitas, California, United States
Raoof MD
Encino, California, United States
First OC Dermatology Research Inc
Fountain Valley, California, United States
Marvel Clinical Research LLC
Huntington Beach, California, United States
Long Beach Research Institute
Long Beach, California, United States
Olive View UCLA Education and Research Institute
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Wallace Medical Group Inc
Los Angeles, California, United States
Northridge Clinical Trials
Northridge, California, United States
Pasadena Clinical Trials
Pasadena, California, United States
Empire Clinical Research Pomona
Pomona, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Southern California Clinical Research
Santa Ana, California, United States
Clinical Science Institute Dermatology Institute
Santa Monica, California, United States
Unison Clinical Trials
Sherman Oaks, California, United States
California Dermatology Institute Thousand Oaks
Thousand Oaks, California, United States
Sunwise Clinical Research LLC
Walnut Creek, California, United States
Clearlyderm Dermatology West Boca Raton
Boca Raton, Florida, United States
Driven Clinical Research
Coral Gables, Florida, United States
FXM Clinical Research Ft. Lauderdale LLC
Fort Lauderdale, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Glick Skin Institute
Margate, Florida, United States
AppleMed Research Group
Miami, Florida, United States
FAX Pharma Clinical Research Inc
Miami, Florida, United States
FXM Clinical Research Miami LLC
Miami, Florida, United States
Las Mercedes Medical Research
Miami, Florida, United States
Procare Research Center
Miami Gardens, Florida, United States
San Marcus Research Clinic Inc - Miami
Miami Lakes, Florida, United States
Savin Medical Group LLC
Miami Lakes, Florida, United States
FXM Clinical Research Miramar LLC
Miramar, Florida, United States
Oceanic Research Group
North Miami Beach, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Lenus Research and Medical Group LLC
Sweetwater, Florida, United States
Advanced Clinical Research Institute
Tampa, Florida, United States
ForCare Medical Center
Tampa, Florida, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
NorthShore Medical Group Dermatology Skokie
Skokie, Illinois, United States
Dundee Dermatology
West Dundee, Illinois, United States
DS Research of Southern Indiana
Clarksville, Indiana, United States
Dawes Fretzin Clinical Research Group
Columbus, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
The South Bend Clinic
South Bend, Indiana, United States
Equity Medical
Bowling Green, Kentucky, United States
DS Research of Kentucky
Louisville, Kentucky, United States
Velocity Clinical Research
Baton Rouge, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
MetroBoston Clinical Partners
Brighton, Massachusetts, United States
Michigan Center for Research Company
Clarkston, Michigan, United States
Henry Ford Medical Center Farmington
Detroit, Michigan, United States
Revival Research Institute
Troy, Michigan, United States
Grekin Skin Institute
Warren, Michigan, United States
Associated Skin Care Specialists Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Cleaver Dermatology
Kirksville, Missouri, United States
Schlessinger MD
Omaha, Nebraska, United States
Las Vegas Clinical Trials
Las Vegas, Nevada, United States
NYC Health and Hospitals Elmhurst
Elmhurst, New York, United States
Pioneer Clinical Research NY
New York, New York, United States
Cameron Dermatology
New York, New York, United States
OptiSkin
New York, New York, United States
DermResearchCenter of New York
Stony Brook, New York, United States
Asheville Clinical Trials
Asheville, North Carolina, United States
WDC Cosmetic and Research
Wilmington, North Carolina, United States
Optima Research Boardman
Boardman, Ohio, United States
The Ohio State University Wexner Medical Center OSUWMC OSU Dermatology East Columbus
Gahanna, Ohio, United States
Dermatologists of Southwestern Ohio LLC
Mason, Ohio, United States
Unity Clinical Research UCR
Oklahoma City, Oklahoma, United States
Velocity Clinical Research
Medford, Oregon, United States
Oregon Medical Research Center
Portland, Oregon, United States
Paddington Testing Company Inc
Philadelphia, Pennsylvania, United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, United States
Clinical Partners LLC
Johnston, Rhode Island, United States
Studies in Dermatology LLC
Cypress, Texas, United States
Modern Research Associates PLLC
Dallas, Texas, United States
Reveal Research Institute
Frisco, Texas, United States
Center for Clinical Studies Texas Medical Center
Houston, Texas, United States
Austin Institute for Clinical Research
Houston, Texas, United States
SMS Clinical Research
Mesquite, Texas, United States
Progressive Clinical Research San Antonio
San Antonio, Texas, United States
Center for Clinical Studies (CCS) - Webster/Clear Lake Location
Webster, Texas, United States
University of Utah Health Care Midvalley Health Center
Murray, Utah, United States
Jordan Valley Dermatology
South Jordan, Utah, United States
Frontier Dermatology
Mill Creek, Washington, United States
Premier Specialist
Kogarah, New South Wales, Australia
North Eastern Health Specialists
Campbelltown, South Australia, Australia
Skin Health Institute
Carlton, Victoria, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Multiprofile Hospital for Active Treatment Dr Tota Venkova
Gabrovo, Bulgaria
Medikal Center Kordis
Pleven, Bulgaria
Skin and Venereal Diseases Center EOOD
Sofia, Bulgaria
DCC Aleksandrovka
Sofia, Bulgaria