Clinical trial NCT06846541: Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
Official title: An Extension Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy, and Durability of Response to ESK-001
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Plaque Psoriasis
Psoriasis (PsO)
Psoriasis
Moderate Psoriasis
Severe Psoriasis
Keywords: Psoriasis
PASI
Safety
ESK-001
Lead sponsor: Alumis Inc
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 1680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the ESK-001-018 long term extension is to evaluate the safety and efficacy of ESK-001 over time. The scientific questions it aims to answer are:

* How safe is taking ESK-001 long-term in people with moderate to severe plaque psoriasis?
* Does taking ESK-001 long-term reduce the severity of people's plaque psoriasis?

Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks. After 24 weeks, the first 200 patients meeting at least PASI-75 clinical response will be randomly assigned to receive ESK-001 or placebo. At any point during this time, the patients losing the initial clinical response may return to the open-label ESK-001 treatment. Patients who complete Week 48 will return to open-label ESK-001 treatment and they will receive ESK-001 until the end of the study or discontinuation. All the remaining patients not meeting the entry criteria for the randomized withdrawal phase will continue to receive open-label ESK-001 for the remainder of the study.

Patients taking part in the study must be men or women aged at least 18 years old and have completed a previous (parent) study of ESK-001 in moderate to severe plaque psoriasis.

Patients must consent and agree to:

* ensure drug daily compliance until end of study or discontinuation.
* visit the clinic for checkups and assessments.
* provide blood and urine samples.


Eligibility criteria: Inclusion Criteria:

1. Males or females, age ≥18 years
2. Completed either of the two previous (parent) studies of ESK-001 (ESK-001-016 or ESK-001-017)
3. ESK-001 safety and tolerability were acceptable in the parent study
4. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception for the entirety of the study

Exclusion Criteria:

1. Pregnant, lactating, or planning to get pregnant during the study period
2. Any acute or chronic illness/condition or evidence of an unstable clinical condition that in the Investigator's judgment will substantially increase the risk to the patient if they continue to receive ESK-001 treatment in this extension study
3. Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol

Primary outcomes:
measure: To assess the long-term safety and tolerability of ESK-001 throughout the duration of the study
timeFrame: Approximately 4 years
Secondary outcomes:
measure: To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-75)
timeFrame: 24, 48, 72, and 96 weeks
measure: To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-90)
timeFrame: 24, 48, 72, and 96 weeks
measure: To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-100)
timeFrame: 24, 48, 72, and 96 weeks
measure: To assess the long-term efficacy of ESK-001 using the Static Physician's Global Assessment (sPGA 0/1)
timeFrame: 24, 48, 72, and 96 weeks
measure: To assess the long-term efficacy of ESK-001 based on change in Psoriasis Area and Severity Index (PASI)
timeFrame: 24, 48, 72, and 96 weeks
measure: To assess the long-term efficacy of ESK-001 based on change in Affected Body Surface Area (%BSA)
timeFrame: 24, 48, 72, and 96 weeks
measure: To characterize the loss of PASI-75 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)
timeFrame: Week 48
measure: To characterize the loss of PASI-90 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)
timeFrame: Week 48
measure: To characterize the loss of sPGA-0/1 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)
timeFrame: Week 48
measure: To assess the change in quality of life (QoL) using Dermatology Life Quality Index after long-term ESK-001 administration
timeFrame: Week 24, Week 48, and Week 72
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Dermatology
state: Alabama
city: Chandler
country: United States
facility: Chandler Clinical Trials
state: Arizona
city: Pheonix
country: United States
facility: Alliance Dermatology
state: Arizona
city: Chula Vista
country: United States
facility: Exalt Clinical Research Inc
state: California
city: Encinitas
country: United States
facility: California Dermatology and Clinical Research Institute
state: California
city: Encino
country: United States
facility: Raoof MD
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research LLC
state: California
city: Long Beach
country: United States
facility: Long Beach Research Institute
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Northridge
country: United States
facility: Northridge Clinical Trials
state: California
city: Pomona
country: United States
facility: Empire Clinical Research Pomona
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Santa Ana
country: United States
facility: Southern California Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Unison Clinical Trials
state: California
city: Thousand Oaks
country: United States
facility: California Dermatology Institute Thousand Oaks
state: California
city: Walnut Creek
country: United States
facility: Sunwise Clinical Research LLC
state: California
city: Boca Raton
country: United States
facility: Clearlyderm Dermatology West Boca Raton
state: Florida
city: Coral Gables
country: United States
facility: Driven Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: FXM Clinical Research Ft. Lauderdale LLC
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Margate
country: United States
facility: Glick Skin Institute
state: Florida
city: Miami Gardens
country: United States
facility: Procare Research Center
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group LLC
state: Florida
city: Miami
country: United States
facility: AppleMed Research Group
state: Florida
city: Miami
country: United States
facility: FAX Pharma Clinical Research Inc
state: Florida
city: Miami
country: United States
facility: FXM Clinical Research Miami LLC
state: Florida
city: Miami
country: United States
facility: Las Mercedes Medical Research
state: Florida
city: Miramar
country: United States
facility: FXM Clinical Research Miramar LLC
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research and Medical Group LLC
state: Florida
city: Tampa
country: United States
facility: ForCare Medical Center
state: Florida
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Skokie
country: United States
facility: NorthShore Medical Group Dermatology Skokie
state: Illinois
city: Clarksville
country: United States
facility: DS Research of Southern Indiana
state: Indiana
city: Columbus
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic
state: Indiana
city: Louisville
country: United States
facility: DS Research of Kentucky
state: Kentucky
city: Baton Rouge
country: United States
facility: Velocity Clinical Research
state: Louisiana
city: Clarkston
country: United States
facility: Michigan Center for Research Company
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute
state: Michigan
city: New Brighton
country: United States
facility: Associated Skin Care Specialists Minnesota Clinical Study Center
state: Minnesota
city: New York
country: United States
facility: OptiSkin
state: New York
city: Wilmington
country: United States
facility: WDC Cosmetic and Research
state: North Carolina
city: Gahanna
country: United States
facility: The Ohio State University Wexner Medical Center OSUWMC OSU Dermatology East Columbus
state: Ohio
city: Mason
country: United States
facility: Dermatologists of Southwestern Ohio LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Unity Clinical Research UCR
state: Oklahoma
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners LLC
state: Rhode Island
city: Cypress
country: United States
facility: Studies in Dermatology LLC
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates PLLC
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies Texas Medical Center
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research San Antonio
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies (CCS) - Webster/Clear Lake Location
state: Texas
city: Mill Creek
country: United States
facility: Frontier Dermatology
state: Washington
city: Kogarah
country: Australia
facility: Premier Specialist
state: New South Wales
city: Campbelltown
country: Australia
facility: North Eastern Health Specialists
state: South Australia
city: Surrey
country: Canada
facility: Enverus Medical
state: British Columbia
city: Ajax
country: Canada
facility: CCA Medical Research Corp
state: Ontario
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research Inc
state: Ontario
city: London
country: Canada
facility: Centricity Research London
state: Ontario
city: London
country: Canada
facility: Derm Effects
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research Inc
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatolgy Centre
state: Ontario
city: North York
country: Canada
facility: Canadian Dermatology Centre
state: Ontario
city: Oakville
country: Canada
facility: Institute of Cosmetic and Laser Surgery
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: North York Research Inc
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Montréal
country: Canada
facility: Innovaderm
state: Quebec
city: Caguas
country: Puerto Rico
facility: Centro Reumatologico de Cagus
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico
Study officials:
References: