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NCT05739435 Clinical Trial

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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05739435
Other study ID # ESK-001-007
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date January 17, 2023
Est. completion date December 30, 2026

Study information
Verified date November 2023
Source Alumis Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 165
Est. completion date December 30, 2026
Est. primary completion date December 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• ESK-001
Oral tablet

Locations
Country Name City State
Canada Investigator Site #2001 Edmonton Alberta
Canada Investigator Site #2006 London Ontario
Canada Investigator Site # 2004 Mississauga Ontario
Canada Investigator Site # 2007 North Bay Ontario
Canada Investigator Site #2005 Oakville Ontario
Canada Investigator Site # 2010 Quebec
Canada Investigator Site # 2008 Surrey British Columbia
Canada Investigator Site #2009 Toronto Ontario
Canada Investigator Site # 2002 Waterloo Ontario
Canada Investigator Site #2003 Winnipeg Manitoba
United States Investigator Site # 1029 Birmingham Alabama
United States Investigator Site #1010 Clarkston Michigan
United States Investigator Site # 1011 Columbus Indiana
United States Investigator Site #1021 Encinitas California
United States Investigator site # 1030 Fort Lauderdale Florida
United States Investigator Site #1025 Hialeah Florida
United States Investigator Site #1015 Houston Texas
United States Investigator Site #1018 Los Angeles California
United States Investigator Site #1035 Macon Georgia
United States Investigator site # 1028 Miami Florida
United States Investigator Site #1031 New Brighton Minnesota
United States Investigator Site #1033 Norman Oklahoma
United States Investigator SIte#1036 Overland Park Kansas
United States Investigator Site #1017 Owensboro Kentucky
United States Investigator Site #1022 Philadelphia Pennsylvania
United States Investigator Site #1001 Phoenix Arizona
United States Investigator Site #1019 Portland Oregon
United States Investigator Site # 1012 Rapid City South Dakota
United States Investigator Site #1026 Rockville Maryland
United States Investigator Site # 1023 Rogers Arkansas
United States Investigator Site #1005 Rolling Meadows Illinois
United States Investigator Site # 1006 San Antonio Texas
United States Investigator Site #1043 Sandy Springs Georgia
United States Investigator Site #1007 Santa Monica California
United States Investigator Site #1002 Sherman Oaks California
United States Investigator Site #1027 South Bend Indiana
United States Investigator Site # 1041 South Jordan Utah
United States Investigator Site # 1013 Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Alumis Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the safety and tolerability of long-term ESK-001 treatment Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) Approximately 3 years
Secondary To assess the long-term efficacy of ESK-001 Change from baseline in Psoriasis Area and Severity Index (PASI) over time Approximately 3 years
Secondary To assess the change in quality of life (QoL) with long-term ESK-001 administration Change from baseline in Dermatology Life Quality Index (DLQI) over time Approximately 3 years
Secondary To assess the pharmacokinetics (PK) of ESK-001 (ctrough) Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001 2 years
See also
  Status Clinical Trial Phase
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Recruiting NCT06030076 - A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis
Completed NCT04263610 - Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy Phase 4
Completed NCT02601469 - Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis Phase 2
Completed NCT05600036 - A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis Phase 2
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03614078 - A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis Phase 2
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Recruiting NCT02611349 - Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis Phase 3
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Completed NCT01987843 - Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 2
Terminated NCT01708629 - Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects Phase 3
Completed NCT01230138 - Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis Phase 2
Withdrawn NCT00747032 - To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis Phase 3
Completed NCT00581100 - Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis Phase 4
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Completed NCT00540618 - A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis Phase 2