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

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis

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

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: ESK-001

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.

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C3
      • Investigator Site #2001
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Investigator Sie #2008
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Investigator Site #2003
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Investigator Site #2006
    • Mississauga, Ontario, Canada, L4Y 4C5
      • Investigator Site #2004
    • North Bay, Ontario, Canada, P1B 3Z7
      • Investigator Site #2007
    • Oakville, Ontario, Canada, L6J 7W5
      • Investigator Site #2005
    • Toronto, Ontario, Canada, M3H 5Y8
      • Investigator Site #2009
    • Waterloo, Ontario, Canada, N2J 1C4
      • Investigator Site #2002
  • Quebec
    • Quebec City, Quebec, Canada, G1V 4X7
      • Investigator Site #2010
• Czechia
  • Novy Jicin, Czechia, 741 01
    • Investigator Site #5507
  • Pardubice, Czechia, 530 02
    • Investigator Site #5514
  • Praha 10, Czechia, 100 00
    • Investigator Site #5506
  • Praha 10, Czechia, 100 34
    • Investigator Site #5505
  • Pardubice
    • Svitavy, Pardubice, Czechia, 568 02
      • Investigator Site #5515
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Investigator Site #1029
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Investigator Site # 1001
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Investigator Site #1023
  • California
    • Encinitas, California, United States, 92024
      • Investigator Site #1021
    • Fremont, California, United States, 94538
      • Investigator Site # 1008
    • Los Angeles, California, United States, 90033
      • Investigator Site #1024
    • Los Angeles, California, United States, 90045
      • Investigator Site # 1018
    • San Diego, California, United States, 92123
      • Investigator Site #1016
    • Santa Monica, California, United States, 90404
      • Investigator Site # 1007
    • Sherman Oaks, California, United States, 91403
      • Investigator Site # 1002
  • Florida
    • Brandon, Florida, United States, 33511
      • Investigator Site #1039
    • Brandon, Florida, United States, 33756
      • Investigator Site #1013
    • Fort Lauderdale, Florida, United States, 33308
      • Investigator Site #1030
    • Hialeah, Florida, United States, 33012
      • Investigator Site #1025
    • Miami, Florida, United States, 33175
      • Investigator Site #1028
    • Tampa, Florida, United States, 33613
      • Investigator Site #1042
  • Georgia
    • Macon, Georgia, United States, 31217
      • Investigator Site #1035
    • Sandy Springs, Georgia, United States, 30328
      • Investigator Site #1043
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Investigator Site # 1005
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Investigator Site #1011
    • South Bend, Indiana, United States, 46617
      • Investigator Site #1027
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Investigator Site #1036
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Investigator Site #1034
    • Owensboro, Kentucky, United States, 42303
      • Investigator Site #1017
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Investigator Site #1026
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Investigator Site #1009
    • Clarkston, Michigan, United States, 48346
      • Investigator Site # 1010
    • Warren, Michigan, United States, 48088
      • Investigator Site #1038
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Investigator Site #1031
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Investigator Site #1014
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Investigator Site #1037
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73170
      • Investigator Site #1033
  • Oregon
    • Portland, Oregon, United States, 97223
      • Investigator Site # 1019
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Investigator Site #1022
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Investigator Site #1012
  • Texas
    • Houston, Texas, United States, 77056
      • Investigator Site # 1015
    • San Antonio, Texas, United States, 78213
      • Investigator Site #1006
  • Utah
    • South Jordan, Utah, United States, 84095
      • Investigator Site #1041

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESK-001 Dose Level 1; ESK-001 administered as an oral tablet	Drug: ESK-001; Oral tablet
Experimental: ESK-001 Dose Level 2; ESK-001 administered as an oral tablet	Drug: ESK-001; Oral tablet
Experimental: ESK-001 Dose Level 3; ESK-001 administered as an oral tablet	Drug: ESK-001; Oral tablet
Experimental: ESK-001 Dose Level 4; ESK-001 administered as an oral tablet	Drug: ESK-001; Oral tablet
Experimental: ESK-001 Dose Level 5; ESK-001 administered as an oral tablet	Drug: ESK-001; Oral tablet
Placebo Comparator: Placebo; Placebo administered as an oral tablet	Drug: Placebo; Oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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). See Adverse Events section.	12 weeks
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
To Characterize the Pharmacokinetics (PK) of ESK-001	Plasma concentrations and PK parameters of ESK-001.	14 weeks

Collaborators and Investigators

• Sponsor: Alumis Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Actual): June 29, 2023
• Study Completion (Actual): July 25, 2023

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: ESK-001-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No