Clinical trial NCT05739435: Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis
Official title: A Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Patients With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Alumis Inc
Sponsor class: INDUSTRY
First posted: 2023-02-22
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Must have completed a prior ESK-001 study
* Men and Women must use highly effective methods of contraception for the entirety of the study

Exclusion Criteria:

* Pregnancy
* Received a prohibited concomitant medication

Primary outcomes:
measure: To assess the safety and tolerability of long-term ESK-001 treatment
timeFrame: Approximately 3 years
Secondary outcomes:
measure: To assess the long-term efficacy of ESK-001
timeFrame: Approximately 3 years
measure: To assess the change in quality of life (QoL) with long-term ESK-001 administration
timeFrame: Approximately 3 years
measure: To assess the pharmacokinetics (PK) of ESK-001 (ctrough)
timeFrame: 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigator Site # 1029
state: Alabama
city: Phoenix
country: United States
facility: Investigator Site #1001
state: Arizona
city: Rogers
country: United States
facility: Investigator Site # 1023
state: Arkansas
city: Encinitas
country: United States
facility: Investigator Site #1021
state: California
city: Los Angeles
country: United States
facility: Investigator Site #1018
state: California
city: Santa Monica
country: United States
facility: Investigator Site #1007
state: California
city: Sherman Oaks
country: United States
facility: Investigator Site #1002
state: California
city: Fort Lauderdale
country: United States
facility: Investigator site # 1030
state: Florida
city: Hialeah
country: United States
facility: Investigator Site #1025
state: Florida
city: Miami
country: United States
facility: Investigator site # 1028
state: Florida
city: Tampa
country: United States
facility: Investigator Site # 1013
state: Florida
city: Macon
country: United States
facility: Investigator Site #1035
state: Georgia
city: Sandy Springs
country: United States
facility: Investigator Site #1043
state: Georgia
city: Rolling Meadows
country: United States
facility: Investigator Site #1005
state: Illinois
city: Columbus
country: United States
facility: Investigator Site # 1011
state: Indiana
city: South Bend
country: United States
facility: Investigator Site #1027
state: Indiana
city: Overland Park
country: United States
facility: Investigator SIte#1036
state: Kansas
city: Owensboro
country: United States
facility: Investigator Site #1017
state: Kentucky
city: Rockville
country: United States
facility: Investigator Site #1026
state: Maryland
city: Clarkston
country: United States
facility: Investigator Site #1010
state: Michigan
city: New Brighton
country: United States
facility: Investigator Site #1031
state: Minnesota
city: Norman
country: United States
facility: Investigator Site #1033
state: Oklahoma
city: Portland
country: United States
facility: Investigator Site #1019
state: Oregon
city: Philadelphia
country: United States
facility: Investigator Site #1022
state: Pennsylvania
city: Rapid City
country: United States
facility: Investigator Site # 1012
state: South Dakota
city: Houston
country: United States
facility: Investigator Site #1015
state: Texas
city: San Antonio
country: United States
facility: Investigator Site # 1006
state: Texas
city: South Jordan
country: United States
facility: Investigator Site # 1041
state: Utah
city: Edmonton
country: Canada
facility: Investigator Site #2001
state: Alberta
city: Surrey
country: Canada
facility: Investigator Site # 2008
state: British Columbia
city: Winnipeg
country: Canada
facility: Investigator Site #2003
state: Manitoba
city: London
country: Canada
facility: Investigator Site #2006
state: Ontario
city: Mississauga
country: Canada
facility: Investigator Site # 2004
state: Ontario
city: North Bay
country: Canada
facility: Investigator Site # 2007
state: Ontario
city: Oakville
country: Canada
facility: Investigator Site #2005
state: Ontario
city: Toronto
country: Canada
facility: Investigator Site #2009
state: Ontario
city: Waterloo
country: Canada
facility: Investigator Site # 2002
state: Ontario
city: Quebec
country: Canada
facility: Investigator Site # 2010
Study officials:
References: