Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis

NCT ID: NCT05739435

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2026-12-30

Brief Summary

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This is a multi-center, open-label extension (OLE) study in patients with plaque psoriasis who have completed their participation in a previous plaque psoriasis study of ESK-001.

Detailed Description

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This study will consist of patients who have completed their participation in a previous plaque psoriasis study of ESK-001. Each patient will be assigned to receive ESK-001 at one of two open-label dose levels. Patients have the option to remain on study until ESK-001 is commercially available.

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

NONE

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

Interventions

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ESK-001

Oral tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must have completed a prior ESK-001 study
* Men and Women must use highly effective methods of contraception for the entirety of the study

Exclusion Criteria

* Pregnancy
* Received a prohibited concomitant medication
Minimum Eligible Age

18 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

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Investigator Site #1018

Los Angeles, California, United States

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Investigator Site #1007

Santa Monica, California, United States

Site Status

Investigator Site #1002

Sherman Oaks, California, United States

Site Status

Investigator site # 1030

Fort Lauderdale, Florida, United States

Site Status

Investigator Site #1025

Hialeah, Florida, United States

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Investigator site # 1028

Miami, Florida, United States

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Investigator Site # 1013

Tampa, Florida, United States

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Investigator Site #1035

Macon, Georgia, United States

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Investigator Site #1043

Sandy Springs, Georgia, United States

Site Status

Investigator Site #1005

Rolling Meadows, Illinois, United States

Site Status

Investigator Site # 1011

Columbus, 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 #1017

Owensboro, Kentucky, United States

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Investigator Site #1026

Rockville, Maryland, United States

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Investigator Site #1010

Clarkston, Michigan, United States

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Investigator Site #1031

New Brighton, Minnesota, United States

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Investigator Site #1033

Norman, Oklahoma, United States

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Investigator Site #1019

Portland, Oregon, United States

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Investigator Site #1022

Philadelphia, Pennsylvania, United States

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Investigator Site # 1012

Rapid City, South Dakota, United States

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Investigator Site #1015

Houston, Texas, United States

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Investigator Site # 1006

San Antonio, Texas, United States

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Investigator Site # 1041

South Jordan, Utah, United States

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Investigator Site #2001

Edmonton, Alberta, Canada

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Investigator Site # 2008

Surrey, British Columbia, Canada

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Investigator Site #2003

Winnipeg, Manitoba, Canada

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Investigator Site #2006

London, Ontario, Canada

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Investigator Site # 2004

Mississauga, Ontario, Canada

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Investigator Site # 2007

North Bay, Ontario, Canada

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Investigator Site #2005

Oakville, Ontario, Canada

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Investigator Site #2009

Toronto, Ontario, Canada

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Investigator Site # 2002

Waterloo, Ontario, Canada

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Investigator Site # 2010

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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ESK-001-007

Identifier Type: -

Identifier Source: org_study_id

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