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

NCT ID: NCT05600036

Last Updated: 2025-06-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-27

Study Completion Date

2023-07-25

Brief Summary

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

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Detailed Description

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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.

Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ESK-001 Dose Level 1

ESK-001 administered as an oral tablet

Group Type EXPERIMENTAL

ESK-001

Intervention Type DRUG

Oral tablet

ESK-001 Dose Level 2

ESK-001 administered as an oral tablet

Group Type EXPERIMENTAL

ESK-001

Intervention Type DRUG

Oral tablet

ESK-001 Dose Level 3

ESK-001 administered as an oral tablet

Group Type EXPERIMENTAL

ESK-001

Intervention Type DRUG

Oral tablet

ESK-001 Dose Level 4

ESK-001 administered as an oral tablet

Group Type EXPERIMENTAL

ESK-001

Intervention Type DRUG

Oral tablet

ESK-001 Dose Level 5

ESK-001 administered as an oral tablet

Group Type EXPERIMENTAL

ESK-001

Intervention Type DRUG

Oral tablet

Placebo

Placebo administered as an oral tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablet

Interventions

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ESK-001

Oral tablet

Intervention Type DRUG

Placebo

Oral tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alumis Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigator Site #1029

Birmingham, Alabama, United States

Site Status

Investigator Site # 1001

Phoenix, Arizona, United States

Site Status

Investigator Site #1023

Rogers, Arkansas, United States

Site Status

Investigator Site #1021

Encinitas, California, United States

Site Status

Investigator Site # 1008

Fremont, California, United States

Site Status

Investigator Site #1024

Los Angeles, California, United States

Site Status

Investigator Site # 1018

Los Angeles, California, United States

Site Status

Investigator Site #1016

San Diego, California, United States

Site Status

Investigator Site # 1007

Santa Monica, California, United States

Site Status

Investigator Site # 1002

Sherman Oaks, California, United States

Site Status

Investigator Site #1039

Brandon, Florida, United States

Site Status

Investigator Site #1013

Brandon, Florida, United States

Site Status

Investigator Site #1030

Fort Lauderdale, Florida, United States

Site Status

Investigator Site #1025

Hialeah, Florida, United States

Site Status

Investigator Site #1028

Miami, Florida, United States

Site Status

Investigator Site #1042

Tampa, Florida, United States

Site Status

Investigator Site #1035

Macon, Georgia, United States

Site Status

Investigator Site #1043

Sandy Springs, Georgia, United States

Site Status

Investigator Site # 1005

Rolling Meadows, Illinois, United States

Site Status

Investigator Site #1011

Indianapolis, Indiana, United States

Site Status

Investigator Site #1027

South Bend, Indiana, United States

Site Status

Investigator Site #1036

Overland Park, Kansas, United States

Site Status

Investigator Site #1034

Louisville, Kentucky, United States

Site Status

Investigator Site #1017

Owensboro, Kentucky, United States

Site Status

Investigator Site #1026

Rockville, Maryland, United States

Site Status

Investigator Site #1009

Bay City, Michigan, United States

Site Status

Investigator Site # 1010

Clarkston, Michigan, United States

Site Status

Investigator Site #1038

Warren, Michigan, United States

Site Status

Investigator Site #1031

New Brighton, Minnesota, United States

Site Status

Investigator Site #1014

Las Vegas, Nevada, United States

Site Status

Investigator Site #1037

Portsmouth, New Hampshire, United States

Site Status

Investigator Site #1033

Oklahoma City, Oklahoma, United States

Site Status

Investigator Site # 1019

Portland, Oregon, United States

Site Status

Investigator Site #1022

Philadelphia, Pennsylvania, United States

Site Status

Investigator Site #1012

Rapid City, South Dakota, United States

Site Status

Investigator Site # 1015

Houston, Texas, United States

Site Status

Investigator Site #1006

San Antonio, Texas, United States

Site Status

Investigator Site #1041

South Jordan, Utah, United States

Site Status

Investigator Site #2001

Edmonton, Alberta, Canada

Site Status

Investigator Sie #2008

Surrey, British Columbia, Canada

Site Status

Investigator Site #2003

Winnipeg, Manitoba, Canada

Site Status

Investigator Site #2006

London, Ontario, Canada

Site Status

Investigator Site #2004

Mississauga, Ontario, Canada

Site Status

Investigator Site #2007

North Bay, Ontario, Canada

Site Status

Investigator Site #2005

Oakville, Ontario, Canada

Site Status

Investigator Site #2009

Toronto, Ontario, Canada

Site Status

Investigator Site #2002

Waterloo, Ontario, Canada

Site Status

Investigator Site #2010

Québec, Quebec, Canada

Site Status

Investigator Site #5515

Svitavy, Pardubice, Czechia

Site Status

Investigator Site #5507

Nový Jičín, , Czechia

Site Status

Investigator Site #5514

Pardubice, , Czechia

Site Status

Investigator Site #5506

Prague, , Czechia

Site Status

Investigator Site #5505

Prague, , Czechia

Site Status

Countries

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United States Canada Czechia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ESK-001-006

Identifier Type: -

Identifier Source: org_study_id

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