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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06846541
Registration number
NCT06846541
Ethics application status
Date submitted
27/01/2025
Date registered
26/02/2025
Date last updated
15/07/2025
Titles & IDs
Public title
Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
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Scientific 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
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Secondary ID [1]
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ESK-001-018
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Universal Trial Number (UTN)
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Trial acronym
ONWARD3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis
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Psoriasis (PsO)
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Psoriasis
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Moderate Psoriasis
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Severe Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Open-Label ESK-001
Treatment: Drugs - Blinded ESK-001
Treatment: Drugs - Placebo
Experimental: Open-Label ESK-001 - Open-Label ESK-001 administered as an oral tablet
Experimental: Blinded ESK-001 - Blinded ESK-001 administered as an oral tablet
Placebo comparator: Placebo - Matching placebo administered as an oral tablet
Treatment: Drugs: Open-Label ESK-001
Open-Label ESK-001
Treatment: Drugs: Blinded ESK-001
Blinded ESK-001 during Randomized Treatment Withdrawal Period
Treatment: Drugs: Placebo
Placebo during Randomized Treatment Withdrawal Period
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To assess the long-term safety and tolerability of ESK-001 throughout the duration of the study
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Assessment method [1]
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Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
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Timepoint [1]
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Approximately 4 years
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Secondary outcome [1]
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To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-75)
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Assessment method [1]
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Proportion of patients achieving =75% reduction in PASI
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Timepoint [1]
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24, 48, 72, and 96 weeks
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Secondary outcome [2]
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To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-90)
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Assessment method [2]
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Proportion of patients achieving =90% reduction in PASI
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Timepoint [2]
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24, 48, 72, and 96 weeks
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Secondary outcome [3]
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To assess the long-term efficacy of ESK-001 using the Psoriasis Area and Severity Index (PASI-100)
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Assessment method [3]
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Proportion of patients achieving 100% reduction in PASI
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Timepoint [3]
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24, 48, 72, and 96 weeks
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Secondary outcome [4]
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To assess the long-term efficacy of ESK-001 using the Static Physician's Global Assessment (sPGA 0/1)
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Assessment method [4]
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Proportion of patients achieving a score of 0 or 1 on sPGA
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Timepoint [4]
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24, 48, 72, and 96 weeks
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Secondary outcome [5]
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To assess the long-term efficacy of ESK-001 based on change in Psoriasis Area and Severity Index (PASI)
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Assessment method [5]
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Change in Psoriasis Area and Severity Index (PASI) from baseline assessments
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Timepoint [5]
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24, 48, 72, and 96 weeks
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Secondary outcome [6]
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To assess the long-term efficacy of ESK-001 based on change in Affected Body Surface Area (%BSA)
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Assessment method [6]
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Change in affected body surface area (%BSA) from baseline assessments
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Timepoint [6]
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24, 48, 72, and 96 weeks
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Secondary outcome [7]
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To characterize the loss of PASI-75 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)
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Assessment method [7]
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Median time to loss of PASI-75 response
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Timepoint [7]
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Week 48
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Secondary outcome [8]
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To characterize the loss of PASI-90 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)
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Assessment method [8]
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Median time to loss of PASI-90 response
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Timepoint [8]
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Week 48
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Secondary outcome [9]
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To characterize the loss of sPGA-0/1 response following withdrawal of ESK-001 treatment (only for patients randomized to the treatment withdrawal phase)
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Assessment method [9]
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Median time to loss of sPGA-0/1 response
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Timepoint [9]
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Week 48
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Secondary outcome [10]
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To assess the change in quality of life (QoL) using Dermatology Life Quality Index after long-term ESK-001 administration
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Assessment method [10]
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Proportion of patients achieving a DLQI-0/1 score of 0 (no effect) or 1 (minimal effect)
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Timepoint [10]
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Week 24, Week 48, and Week 72
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/01/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2028
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Actual
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Sample size
Target
1680
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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Premier Specialist - Kogarah
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Recruitment hospital [2]
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North Eastern Health Specialists - Campbelltown
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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5074 - Campbelltown
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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State/province [2]
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Arizona
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Arkansas
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United States of America
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California
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United States of America
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Florida
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Illinois
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Indiana
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Kentucky
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Louisiana
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Michigan
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Minnesota
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Country [12]
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New York
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Country [13]
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North Carolina
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Ohio
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State/province [15]
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Oklahoma
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Oregon
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Rhode Island
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Texas
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Utah
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Washington
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Country [21]
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Canada
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British Columbia
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Country [22]
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Canada
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Ontario
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Country [23]
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Canada
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State/province [23]
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Quebec
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Country [24]
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Czechia
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State/province [24]
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Kralovehradecky kraj
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Country [25]
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Czechia
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State/province [25]
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Kutná Hora
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Country [26]
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Czechia
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State/province [26]
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Nový Jicín
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Country [27]
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Czechia
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State/province [27]
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Olomouc
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Country [28]
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Czechia
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State/province [28]
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Ostrava
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Country [29]
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Czechia
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State/province [29]
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Pardubice
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Country [30]
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Czechia
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State/province [30]
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Prague
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Czechia
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State/province [31]
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Praha
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Country [32]
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Germany
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NRW
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Country [33]
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Poland
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State/province [33]
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Dolnoslaskie
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Lodz
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State/province [35]
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Malopolska
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Pomorskie
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Poneranian
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Poland
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Zachodniopomorskie
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Poland
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Kraków
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Poland
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Warsaw
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Puerto Rico
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Caguas
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Puerto Rico
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Ponce
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Country [43]
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Puerto Rico
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State/province [43]
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San Juan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Alumis Inc
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06846541
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Alumis Information
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Address
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Country
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Phone
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(650) 231-6625
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06846541
Download to PDF