Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
- Conditions
- Plaque PsoriasisPsoriasis (PsO)PsoriasisModerate PsoriasisSevere Psoriasis
- Interventions
- Drug: Open-Label ESK-001Drug: Blinded ESK-001Drug: Placebo
- Registration Number
- NCT06846541
- Lead Sponsor
- Alumis Inc
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1680
- 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
- Pregnant, lactating, or planning to get pregnant during the study period
- Any acute or chronic illness/condition or evidence of an unstable clinical condition that in the Investigator's judgment will substantially increase the risk to the patient if they continue to receive ESK-001 treatment in this extension study
- Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Open-Label ESK-001 Open-Label ESK-001 Open-Label ESK-001 administered as an oral tablet Blinded ESK-001 Blinded ESK-001 Blinded ESK-001 administered as an oral tablet Placebo Placebo Matching placebo administered as an oral tablet
- Primary Outcome Measures
Name Time Method To assess the long-term safety and tolerability of ESK-001 throughout the duration of the study Approximately 4 years Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
- Secondary Outcome Measures
Name Time Method To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-75) 24, 48, 72, and 96 weeks Proportion of patients achieving ≥75% reduction in PASI
To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-90) 24, 48, 72, and 96 weeks Proportion of patients achieving ≥90% reduction in PASI
To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-100) 24, 48, 72, and 96 weeks Proportion of patients achieving 100% reduction in PASI
To assess the long-term efficacy of ESK-001 using the Static Physician's Global Assessment (sPGA 0/1) 24, 48, 72, and 96 weeks Proportion of patients achieving a score of 0 or 1 on sPGA
To assess the long-term efficacy of ESK-001 based on change in Psoriasis Area and Severity Index (PASI) 24, 48, 72, and 96 weeks Change in Psoriasis Area and Severity Index (PASI) from baseline assessments
To assess the long-term efficacy of ESK-001 based on change in Affected Body Surface Area (%BSA) 24, 48, 72, and 96 weeks Change in affected body surface area (%BSA) from baseline assessments
To characterize the loss of PASI-75 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase) Week 48 Median time to loss of PASI-75 response
To characterize the loss of PASI-90 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase) Week 48 Median time to loss of PASI-90 response
To characterize the loss of sPGA-0/1 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase) Week 48 Median time to loss of sPGA-0/1 response
To assess the change in quality of life (QoL) using Dermatology Life Quality Index after long-term ESK-001 administration Week 24, Week 48, and Week 72 Proportion of patients achieving a DLQI-0/1 score of 0 (no effect) or 1 (minimal effect)
Related Research Topics
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Trial Locations
- Locations (64)
Derm Effects
🇨🇦London, Ontario, Canada
Lynderm Research
🇨🇦Markham, Ontario, Canada
North Bay Dermatolgy Centre
🇨🇦North Bay, Ontario, Canada
Clearlyderm Dermatology West Boca Raton
🇺🇸Boca Raton, Florida, United States
Velocity Clinical Research
🇺🇸Baton Rouge, Louisiana, United States
CCA Medical Research Corp
🇨🇦Ajax, Ontario, Canada
Total Dermatology
🇺🇸Birmingham, Alabama, United States
Chandler Clinical Trials
🇺🇸Chandler, Arizona, United States
Alliance Dermatology
🇺🇸Pheonix, Arizona, United States
Exalt Clinical Research Inc
🇺🇸Chula Vista, California, United States
Raoof MD
🇺🇸Encino, California, United States
Marvel Clinical Research LLC
🇺🇸Huntington Beach, California, United States
Long Beach Research Institute
🇺🇸Long Beach, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Northridge Clinical Trials
🇺🇸Northridge, California, United States
Empire Clinical Research Pomona
🇺🇸Pomona, California, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
Southern California Clinical Research
🇺🇸Santa Ana, 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
FXM Clinical Research Ft. Lauderdale LLC
🇺🇸Fort Lauderdale, Florida, United States
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Glick Skin Institute
🇺🇸Margate, Florida, United States
Procare Research Center
🇺🇸Miami Gardens, Florida, United States
Savin Medical Group LLC
🇺🇸Miami Lakes, 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
FXM Clinical Research Miramar LLC
🇺🇸Miramar, Florida, United States
Lenus Research and Medical Group LLC
🇺🇸Sweetwater, 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
Dawes Fretzin Clinical Research Group
🇺🇸Columbus, Indiana, United States
The South Bend Clinic
🇺🇸South Bend, Indiana, United States
DS Research of Kentucky
🇺🇸Louisville, Kentucky, United States
Michigan Center for Research Company
🇺🇸Clarkston, Michigan, United States
Revival Research Institute
🇺🇸Troy, Michigan, United States
Associated Skin Care Specialists Minnesota Clinical Study Center
🇺🇸New Brighton, Minnesota, United States
OptiSkin
🇺🇸New York, New York, United States
WDC Cosmetic and Research
🇺🇸Wilmington, North Carolina, United States
Dermatologists of Southwestern Ohio LLC
🇺🇸Mason, Ohio, United States
Unity Clinical Research UCR
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Medical Research Center
🇺🇸Portland, Oregon, 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
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
SimcoDerm Medical and Surgical Dermatology Center
🇨🇦Barrie, Ontario, Canada
Dermatrials Research Inc
🇨🇦Hamilton, Ontario, Canada
Centricity Research London
🇨🇦London, Ontario, Canada
DermEdge Research Inc
🇨🇦Mississauga, Ontario, Canada
Canadian Dermatology Centre
🇨🇦North York, Ontario, Canada
Institute of Cosmetic and Laser Surgery
🇨🇦Oakville, Ontario, Canada
The Centre for Dermatology
🇨🇦Richmond Hill, Ontario, Canada
Toronto Research Centre
🇨🇦Toronto, Ontario, Canada
Centro Reumatologico de Cagus
🇵🇷Caguas, Puerto Rico
Ponce Medical School Foundation Inc
🇵🇷Ponce, Puerto Rico
Clinical Research Puerto Rico
🇵🇷San Juan, Puerto Rico