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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| envudeucitinib Dose Level 1 | Experimental | envudeucitinib administered as an oral tablet |
|
| envudeucitinib Dose Level 2 | Experimental | envudeucitinib administered as an oral tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| envudeucitinib | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of long-term ESK-001 treatment | Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | Approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the long-term efficacy of ESK-001 | Change from baseline in Psoriasis Area and Severity Index (PASI) over time | Approximately 3 years |
| To assess the change in quality of life (QoL) with long-term ESK-001 administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site # 1029 | Birmingham | Alabama | 35205 | United States | ||
| Investigator Site #1001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41061968 | Derived | Papp KA, Jacobs S, Sofen H, Bukhalo M, Muscianisi E, Ma G, Lau G, Bettinger M, Rubio RG, Hitraya E, Blauvelt A; Open-Label Extension study team. Safety and efficacy of envudeucitinib, a highly selective, oral allosteric TYK2 inhibitor, in patients with moderate-to-severe plaque psoriasis: Results from the 52-week open-label extension period of the phase 2 STRIDE study. J Am Acad Dermatol. 2026 Jan;94(1):187-195. doi: 10.1016/j.jaad.2025.10.005. Epub 2025 Oct 6. |
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Change from baseline in Dermatology Life Quality Index (DLQI) over time
| Approximately 3 years |
| To assess the pharmacokinetics (PK) of ESK-001 (ctrough) | Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001 | 2 years |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Investigator Site # 1023 | Rogers | Arkansas | 72758 | United States |
| Investigator Site #1021 | Encinitas | California | 92024 | United States |
| Investigator Site #1018 | Los Angeles | California | 90045 | United States |
| Investigator Site #1007 | Santa Monica | California | 90404 | United States |
| Investigator Site #1002 | Sherman Oaks | California | 91403 | United States |
| Investigator site # 1030 | Fort Lauderdale | Florida | 33308 | United States |
| Investigator Site #1025 | Hialeah | Florida | 33012 | United States |
| Investigator site # 1028 | Miami | Florida | 33175 | United States |
| Investigator Site # 1013 | Tampa | Florida | 33614 | United States |
| Investigator Site #1035 | Macon | Georgia | 31217 | United States |
| Investigator Site #1043 | Sandy Springs | Georgia | 30328 | United States |
| Investigator Site #1005 | Rolling Meadows | Illinois | 60008 | United States |
| Investigator Site # 1011 | Columbus | Indiana | 47201 | United States |
| Investigator Site #1027 | South Bend | Indiana | 46617 | United States |
| Investigator SIte#1036 | Overland Park | Kansas | 66210 | United States |
| Investigator Site #1017 | Owensboro | Kentucky | 42301 | United States |
| Investigator Site #1026 | Rockville | Maryland | 20850 | United States |
| Investigator Site #1010 | Clarkston | Michigan | 48346 | United States |
| Investigator Site #1031 | New Brighton | Minnesota | 55112 | United States |
| Investigator Site #1033 | Norman | Oklahoma | 73071 | United States |
| Investigator Site #1019 | Portland | Oregon | 97223 | United States |
| Investigator Site #1022 | Philadelphia | Pennsylvania | 19103 | United States |
| Investigator Site # 1012 | Rapid City | South Dakota | 57702 | United States |
| Investigator Site #1015 | Houston | Texas | 77056 | United States |
| Investigator Site # 1006 | San Antonio | Texas | 78213 | United States |
| Investigator Site # 1041 | South Jordan | Utah | 84095 | United States |
| Investigator Site #2001 | Edmonton | Alberta | T6G 1C3 | Canada |
| Investigator Site # 2008 | Surrey | British Columbia | V3V 0C6 | Canada |
| Investigator Site #2003 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Investigator Site #2006 | London | Ontario | N6H 5L5 | Canada |
| Investigator Site # 2004 | Mississauga | Ontario | L4Y 4C5 | Canada |
| Investigator Site # 2007 | North Bay | Ontario | PiB 3Z7 | Canada |
| Investigator Site #2005 | Oakville | Ontario | L6J 7W5 | Canada |
| Investigator Site #2009 | Toronto | Ontario | M3H 5Y8 | Canada |
| Investigator Site # 2002 | Waterloo | Ontario | N2J 1C4 | Canada |
| Investigator Site # 2010 | Québec | Quebec | G1V 4X7 | Canada |