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ESK-001

Phase 2

Plaque Psoriasis | Small molecule | Immunology |Alumis Inc.|Last Updated: Jun 18, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment228
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05600036A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque PsoriasisPHASE2 COMPLETED 228Sep 27, 2022Jul 25, 2023Jun 18, 202553 United States, Canada +1
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Study Endpoints
Primary Endpoints
To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo
12 weeks

Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score

Secondary Endpoints
To Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients
12 weeks
To Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score
12 weeks
To Characterize the Pharmacokinetics (PK) of ESK-001
14 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ESK-001 Dose Level 1EXPERIMENTALESK-001 administered as an oral tablet
ESK-001 Dose Level 2EXPERIMENTALESK-001 administered as an oral tablet
ESK-001 Dose Level 3EXPERIMENTALESK-001 administered as an oral tablet
ESK-001 Dose Level 4EXPERIMENTALESK-001 administered as an oral tablet
ESK-001 Dose Level 5EXPERIMENTALESK-001 administered as an oral tablet
PlaceboPLACEBO_COMPARATORPlacebo administered as an oral tablet
Interventions
NameTypeDescription
ESK-001DRUGOral tablet
PlaceboDRUGOral tablet
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites53

Inclusion Criteria: * Total body weight \>40 kg (88 lb) * Men and woman age 18-75 * Men and Women must use highly effective methods of contraception for the entirety of the study Exclusion Criteria: * History of malignancy within the last 5 years * Positive for HIV, Hepatitis B or C * History of ...

Countries:United StatesCanadaCzechia
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