Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Alumis Inc
- Study ID
- NCT05739435
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- envudeucitinib — DRUGOral tablet
Study Details
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.
Key Dates
- Start date
- Jan 17, 2023
- Status verified
- Jun 2026
- Primary completion
- Dec 1, 2026
- Completion
- Dec 30, 2026
Study Design
- Enrollment
- 165 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: envudeucitinib Dose Level 1envudeucitinib administered as an oral tablet
- Experimental: envudeucitinib Dose Level 2envudeucitinib administered as an oral tablet
Primary Outcome Measure
To assess the safety and tolerability of long-term ESK-001 treatment [ Time Frame: Approximately 3 years ]
Locations (28)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Investigator Site # 1029 | Birmingham | Alabama | 35205 | - |
| Investigator Site #1001 | Phoenix | Arizona | 85032 | - |
| Investigator Site # 1023 | Rogers | Arkansas | 72758 | - |
| Investigator Site #1021 | Encinitas | California | 92024 | - |
| Investigator Site #1018 | Los Angeles | California | 90045 | - |
| Investigator Site #1007 | Santa Monica | California | 90404 | - |
| Investigator Site #1002 | Sherman Oaks | California | 91403 | - |
| Investigator site # 1030 | Fort Lauderdale | Florida | 33308 | - |
| Investigator Site #1025 | Hialeah | Florida | 33012 | - |
| Investigator site # 1028 | Miami | Florida | 33175 | - |
| Investigator Site # 1013 | Tampa | Florida | 33614 | - |
| Investigator Site #1035 | Macon | Georgia | 31217 | - |
| Investigator Site #1043 | Sandy Springs | Georgia | 30328 | - |
| Investigator Site #1005 | Rolling Meadows | Illinois | 60008 | - |
| Investigator Site # 1011 | Columbus | Indiana | 47201 | - |
| Investigator Site #1027 | South Bend | Indiana | 46617 | - |
| Investigator SIte#1036 | Overland Park | Kansas | 66210 | - |
| Investigator Site #1017 | Owensboro | Kentucky | 42301 | - |
| Investigator Site #1026 | Rockville | Maryland | 20850 | - |
| Investigator Site #1010 | Clarkston | Michigan | 48346 | - |
| Investigator Site #1031 | New Brighton | Minnesota | 55112 | - |
| Investigator Site #1033 | Norman | Oklahoma | 73071 | - |
| Investigator Site #1019 | Portland | Oregon | 97223 | - |
| Investigator Site #1022 | Philadelphia | Pennsylvania | 19103 | - |
| Investigator Site # 1012 | Rapid City | South Dakota | 57702 | - |
| Investigator Site #1015 | Houston | Texas | 77056 | - |
| Investigator Site # 1006 | San Antonio | Texas | 78213 | - |
| Investigator Site # 1041 | South Jordan | Utah | 84095 | - |
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