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LY3361237

Phase 2

Psoriasis | Small molecule | Dermatology |Eli Lilly and Company|Trials Updated: Dec 5, 2022

LY3361237 development status

Highest phase Phase 2 (NCT05123586)
Phase scored for LLYPhase 1
Registered trials 3 across 1 sponsor since May 2019

LY3361237 target and mechanism

ModalitySmall molecule

Also known as LY3361237 - SC

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment49

FDA Designations

No designations recorded

LY3361237 clinical trials

LY3361237 · 2 trials · 2 indications

Phase 1 2
NCT04975295A Study of LY3361237 in Participants With PsoriasisPsoriasis
COMPLETED21 Analytics
NCT03933943A Study of LY3361237 in Participants With Systemic Lupus ErythematosusLupus Erythematosus, Systemic
COMPLETED28 Analytics
PHASE1COMPLETED
A Study of LY3361237 in Participants With Psoriasis
PsoriasisUnlock trial analytics
PHASE1COMPLETED
A Study of LY3361237 in Participants With Systemic Lupus Erythematosus
Lupus Erythematosus, SystemicUnlock trial analytics

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

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Baseline through Day 155

A summary of 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
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237
Day 1 predose through Day 155
PK: Area Under the Concentration Versus Time Curve (AUC) Over the Dosing Interval of LY3361237
Day 1 predose through Day 155
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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 to 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:BulgariaHungaryPolandSlovakiaUnited States
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Frequently asked questions about LY3361237

What is LY3361237?

LY3361237 is an investigational small molecule being developed by Eli Lilly and Company for immunology indications. It has been studied in Phase 1 clinical trials in participants with systemic lupus erythematosus and psoriasis. It is not yet approved for any use and remains in early clinical development.

What is LY3361237 used for?

LY3361237 has been studied in clinical trials for systemic lupus erythematosus and psoriasis, two immune-mediated conditions. Both programs were Phase 1 studies designed to evaluate the drug in adults with these diseases. No approved indication currently exists for LY3361237.

Who makes LY3361237?

Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY, is the developer of LY3361237. The company sponsored the Phase 1 clinical trials of the drug in systemic lupus erythematosus and psoriasis.

What phase is LY3361237 in?

LY3361237 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in systemic lupus erythematosus and one in psoriasis. The drug is investigational and has not been approved by the FDA or any other regulatory agency for commercial use.

What clinical trials is LY3361237 in?

LY3361237 has been evaluated in two completed Phase 1 trials. NCT03933943 studied the drug in 28 participants with systemic lupus erythematosus in the United States. NCT04975295 studied it in 21 participants with psoriasis across Bulgaria, Hungary, Poland, and Slovakia. Both trials enrolled adults aged 18 and older.

Is LY3361237 the same as LY3361237 - SC?

Yes, LY3361237 - SC is an alternative name used for LY3361237. Both names refer to the same investigational small molecule developed by Eli Lilly and Company for systemic lupus erythematosus and psoriasis. Searches using either name point to the same drug asset.