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

June 3, 2025 updated by: Alumis Inc

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo
Time Frame: 12 weeks
Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Proportion of patients achieving an sPGA score of "0" ("cleared") or "1" ("minimal")
12 weeks
To Characterize the Pharmacokinetics (PK) of ESK-001
Time Frame: 14 weeks
Plasma concentrations and PK parameters of ESK-001.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alumis Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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