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

March 27, 2026 updated by: Alumis Inc

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • 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 Site # 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, PiB 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
      • Québec, Quebec, Canada, G1V 4X7
        • Investigator Site # 2010
  • 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
      • Los Angeles, California, United States, 90045
        • Investigator Site #1018
      • Santa Monica, California, United States, 90404
        • Investigator Site #1007
      • Sherman Oaks, California, United States, 91403
        • Investigator Site #1002
    • Florida
      • 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, 33614
        • Investigator Site # 1013
    • 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
      • Columbus, Indiana, United States, 47201
        • Investigator Site # 1011
      • South Bend, Indiana, United States, 46617
        • Investigator Site #1027
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Investigator SIte#1036
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Investigator Site #1017
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Investigator Site #1026
    • Michigan
      • Clarkston, Michigan, United States, 48346
        • Investigator Site #1010
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Investigator Site #1031
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: envudeucitinib Dose Level 1
envudeucitinib administered as an oral tablet
Drug: envudeucitinib
Oral tablet
Experimental: envudeucitinib Dose Level 2
envudeucitinib administered as an oral tablet
Drug: envudeucitinib
Oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the safety and tolerability of long-term ESK-001 treatment
Time Frame: Approximately 3 years
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the long-term efficacy of ESK-001
Time Frame: Approximately 3 years
Change from baseline in Psoriasis Area and Severity Index (PASI) over time
Approximately 3 years
To assess the change in quality of life (QoL) with long-term ESK-001 administration
Time Frame: Approximately 3 years
Change from baseline in Dermatology Life Quality Index (DLQI) over time
Approximately 3 years
To assess the pharmacokinetics (PK) of ESK-001 (ctrough)
Time Frame: 2 years
Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001
2 years

Collaborators and Investigators

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

Sponsor

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)

January 17, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

February 22, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESK-001-007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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