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LY3361237

Phase 1

Psoriasis | Small molecule | Immunology |Eli Lilly and Company|Last Updated: Dec 5, 2022

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04975295A Study of LY3361237 in Participants With PsoriasisPHASE1 COMPLETED 21Jul 27, 2021Nov 29, 2022Dec 5, 20227 Bulgaria, Hungary +2
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Study Endpoints
Primary Endpoints
Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through Day 253

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Endpoints
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of LY3361237 During the Dosing Interval
Day 1 predose through Day 253
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3361237EXPERIMENTALLY3361237 administered subcutaneously (SC).
PlaceboPLACEBO_COMPARATORPlacebo administered SC.
Interventions
NameTypeDescription
LY3361237DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Have chronic plaque psoriasis for at least 6 months * Be willing and able to undergo skin biopsies * Body mass index (BMI) within the range of 18 to 40 kilograms per meter squared (kg/m²) * Female participants must agree to use birth control during the study Exclusion Criteri...

Countries:BulgariaHungaryPolandSlovakia
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