Clinical trial NCT05600036: A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Alumis Inc
Sponsor class: INDUSTRY
First posted: 2022-10-31
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double-blind, placebo-controlled study in patients with moderate to severe plaque psoriasis.

Detailed description: This study will consist of a 4 week screening period, 12 week treatment period, and a 4 week follow up period for a total of 20 weeks. Each participant will be randomized to receive ESK-001 or placebo daily for 12 weeks. An open label extension study will be available for those patients who complete the study.

Eligibility criteria: Inclusion Criteria:

* Total body weight \>40 kg (88 lb)
* Men and woman age 18-75
* Men and Women must use highly effective methods of contraception for the entirety of the study

Exclusion Criteria:

* History of malignancy within the last 5 years
* Positive for HIV, Hepatitis B or C
* History of tuberculosis
* Diagnosis of non-plaque psoriasis
* Patients with QTcF \>450 msec (males) or \>470 msec (females) at screening
* Live vaccines

Primary outcomes:
measure: To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo
timeFrame: 12 weeks
Secondary outcomes:
measure: To Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients
timeFrame: 12 weeks
measure: To Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score
timeFrame: 12 weeks
measure: To Characterize the Pharmacokinetics (PK) of ESK-001
timeFrame: 14 weeks
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: Fremont
country: United States
facility: Investigator Site # 1008
state: California
city: Los Angeles
country: United States
facility: Investigator Site #1024
state: California
city: Los Angeles
country: United States
facility: Investigator Site # 1018
state: California
city: San Diego
country: United States
facility: Investigator Site #1016
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: Brandon
country: United States
facility: Investigator Site #1039
state: Florida
city: Brandon
country: United States
facility: Investigator Site #1013
state: Florida
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 #1042
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: Indianapolis
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: Louisville
country: United States
facility: Investigator Site #1034
state: Kentucky
city: Owensboro
country: United States
facility: Investigator Site #1017
state: Kentucky
city: Rockville
country: United States
facility: Investigator Site #1026
state: Maryland
city: Bay City
country: United States
facility: Investigator Site #1009
state: Michigan
city: Clarkston
country: United States
facility: Investigator Site # 1010
state: Michigan
city: Warren
country: United States
facility: Investigator Site #1038
state: Michigan
city: New Brighton
country: United States
facility: Investigator Site #1031
state: Minnesota
city: Las Vegas
country: United States
facility: Investigator Site #1014
state: Nevada
city: Portsmouth
country: United States
facility: Investigator Site #1037
state: New Hampshire
city: Oklahoma City
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 Sie #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 City
country: Canada
facility: Investigator Site #2010
state: Quebec
city: Svitavy
country: Czechia
facility: Investigator Site #5515
state: Pardubice
city: Novy Jicin
country: Czechia
facility: Investigator Site #5507
city: Pardubice
country: Czechia
facility: Investigator Site #5514
city: Praha 10
country: Czechia
facility: Investigator Site #5506
city: Praha 10
country: Czechia
facility: Investigator Site #5505
Study officials:
References: