Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis
- Conditions
- Plaque Psoriasis
- Interventions
- Drug: ESK-001
- Registration Number
- NCT05739435
- Lead Sponsor
- Alumis Inc
- Brief Summary
This is a multi-center, open-label extension (OLE) study in patients with plaque psoriasis who have completed their participation in a previous plaque psoriasis study of ESK-001.
- Detailed Description
This study will consist of patients who have completed their participation in a previous plaque psoriasis study of ESK-001. Each patient will be assigned to receive ESK-001 at one of two open-label dose levels. Patients have the option to remain on study until ESK-001 is commercially available.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 165
- Must have completed a prior ESK-001 study
- Men and Women must use highly effective methods of contraception for the entirety of the study
- Pregnancy
- Received a prohibited concomitant medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ESK-001 Dose Level 2 ESK-001 ESK-001 administered as an oral tablet ESK-001 Dose Level 1 ESK-001 ESK-001 administered as an oral tablet
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of long-term ESK-001 treatment Approximately 3 years Incidence 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 Approximately 3 years Change from baseline in Psoriasis Area and Severity Index (PASI) over time
To assess the change in quality of life (QoL) with long-term ESK-001 administration Approximately 3 years Change from baseline in Dermatology Life Quality Index (DLQI) over time
To assess the pharmacokinetics (PK) of ESK-001 (ctrough) 2 years Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001
Trial Locations
- Locations (38)
Investigator Site #1018
🇺🇸Los Angeles, California, United States
Investigator Site #1035
🇺🇸Macon, Georgia, United States
Investigator Site #1017
🇺🇸Owensboro, Kentucky, United States
Investigator Site # 2004
🇨🇦Mississauga, Ontario, Canada
Investigator Site #1025
🇺🇸Hialeah, Florida, United States
Investigator Site #1022
🇺🇸Philadelphia, Pennsylvania, United States
Investigator Site #1031
🇺🇸New Brighton, Minnesota, United States
Investigator Site #1015
🇺🇸Houston, Texas, United States
Investigator site # 1028
🇺🇸Miami, Florida, United States
Investigator Site #2003
🇨🇦Winnipeg, Manitoba, Canada
Investigator SIte#1036
🇺🇸Overland Park, Kansas, United States
Investigator Site #1001
🇺🇸Phoenix, Arizona, United States
Investigator Site # 1023
🇺🇸Rogers, Arkansas, United States
Investigator Site # 2008
🇨🇦Surrey, British Columbia, Canada
Investigator Site # 1012
🇺🇸Rapid City, South Dakota, United States
Investigator Site # 1029
🇺🇸Birmingham, Alabama, United States
Investigator Site #1019
🇺🇸Portland, Oregon, United States
Investigator Site #1021
🇺🇸Encinitas, California, United States
Investigator site # 1030
🇺🇸Fort Lauderdale, Florida, United States
Investigator Site #1002
🇺🇸Sherman Oaks, California, United States
Investigator Site #1043
🇺🇸Sandy Springs, Georgia, United States
Investigator Site #1005
🇺🇸Rolling Meadows, Illinois, United States
Investigator Site # 1011
🇺🇸Columbus, Indiana, United States
Investigator Site #1026
🇺🇸Rockville, Maryland, United States
Investigator Site #1033
🇺🇸Norman, Oklahoma, United States
Investigator Site #1010
🇺🇸Clarkston, Michigan, United States
Investigator Site # 1006
🇺🇸San Antonio, Texas, United States
Investigator Site # 1041
🇺🇸South Jordan, Utah, United States
Investigator Site #2006
🇨🇦London, Ontario, Canada
Investigator Site # 2007
🇨🇦North Bay, Ontario, Canada
Investigator Site #2009
🇨🇦Toronto, Ontario, Canada
Investigator Site #2005
🇨🇦Oakville, Ontario, Canada
Investigator Site # 2002
🇨🇦Waterloo, Ontario, Canada
Investigator Site # 2010
🇨🇦Quebec, Canada
Investigator Site #1027
🇺🇸South Bend, Indiana, United States
Investigator Site #1007
🇺🇸Santa Monica, California, United States
Investigator Site # 1013
🇺🇸Tampa, Florida, United States
Investigator Site #2001
🇨🇦Edmonton, Alberta, Canada