A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05600036
• Other study ID #: ESK-001-006
• Status: Completed
• Phase: Phase 2
• Start date: September 27, 2022
• Est. completion date: July 25, 2023

Study information

• Verified date: August 2023
• Source: Alumis Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: July 25, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• ESK-001
Oral tablet
• Placebo
Oral tablet

Locations

Country	Name	City	State
Canada	Investigator Site #2001	Edmonton	Alberta
Canada	Investigator Site #2006	London	Ontario
Canada	Investigator Site #2004	Mississauga	Ontario
Canada	Investigator Site #2007	North Bay	Ontario
Canada	Investigator Site #2005	Oakville	Ontario
Canada	Investigator Site #2010	Quebec City	Quebec
Canada	Investigator Sie #2008	Surrey	British Columbia
Canada	Investigator Site #2009	Toronto	Ontario
Canada	Investigator Site #2002	Waterloo	Ontario
Canada	Investigator Site #2003	Winnipeg	Manitoba
Czechia	Investigator Site #5507	Novy Jicin
Czechia	Investigator Site #5514	Pardubice
Czechia	Investigator Site #5505	Praha 10
Czechia	Investigator Site #5506	Praha 10
Czechia	Investigator Site #5515	Svitavy	Pardubice
United States	Investigator Site #1009	Bay City	Michigan
United States	Investigator Site #1029	Birmingham	Alabama
United States	Investigator Site #1013	Brandon	Florida
United States	Investigator Site #1039	Brandon	Florida
United States	Investigator Site # 1010	Clarkston	Michigan
United States	Investigator Site #1021	Encinitas	California
United States	Investigator Site #1030	Fort Lauderdale	Florida
United States	Investigator Site # 1008	Fremont	California
United States	Investigator Site #1025	Hialeah	Florida
United States	Investigator Site # 1015	Houston	Texas
United States	Investigator Site #1011	Indianapolis	Indiana
United States	Investigator Site #1014	Las Vegas	Nevada
United States	Investigator Site # 1018	Los Angeles	California
United States	Investigator Site #1024	Los Angeles	California
United States	Investigator Site #1034	Louisville	Kentucky
United States	Investigator Site #1035	Macon	Georgia
United States	Investigator Site #1028	Miami	Florida
United States	Investigator Site #1031	New Brighton	Minnesota
United States	Investigator Site #1033	Oklahoma City	Oklahoma
United States	Investigator Site #1036	Overland Park	Kansas
United States	Investigator Site #1017	Owensboro	Kentucky
United States	Investigator Site #1022	Philadelphia	Pennsylvania
United States	Investigator Site # 1001	Phoenix	Arizona
United States	Investigator Site # 1019	Portland	Oregon
United States	Investigator Site #1037	Portsmouth	New Hampshire
United States	Investigator Site #1012	Rapid City	South Dakota
United States	Investigator Site #1026	Rockville	Maryland
United States	Investigator Site #1023	Rogers	Arkansas
United States	Investigator Site # 1005	Rolling Meadows	Illinois
United States	Investigator Site #1006	San Antonio	Texas
United States	Investigator Site #1016	San Diego	California
United States	Investigator Site #1043	Sandy Springs	Georgia
United States	Investigator Site # 1007	Santa Monica	California
United States	Investigator Site # 1002	Sherman Oaks	California
United States	Investigator Site #1027	South Bend	Indiana
United States	Investigator Site #1041	South Jordan	Utah
United States	Investigator Site #1042	Tampa	Florida
United States	Investigator Site #1038	Warren	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Alumis Inc

Countries where clinical trial is conducted

United States,  Canada,  Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the Psoriasis Area and Severity Index (PASI-75) between doses of ESK-001 and placebo	Proportion of patients with moderate to severe psoriasis achieving =75% reduction in PASI score	12 weeks
Secondary	To assess the safety and tolerability of ESK-001 dose in moderate to severe psoriasis patients	Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	12 weeks
Secondary	To assess the response rate in static Physician's Global Assessment (sPGA) score	Proportion of patients achieving an sPGA score of "0" ("cleared") or "1" ("minimal")	12 weeks
Secondary	To characterize the pharmacokinetics (PK) of ESK-001 (Cmax)	Plasma concentrations and PK parameters including steady-state maximum observed concentration (Cmax) for ESK-001 at Week 8	8 weeks
Secondary	To characterize the pharmacokinetics (PK) of ESK-001 (Ctrough)	Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001 at Week 8	8 weeks