A Study of LY3361237 in Participants With Psoriasis

Study Overview
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Brief Summary
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The main purpose of this study is to learn more about the safety and tolerability of LY3361237 and any side effects that might be associated with it when given to participants with psoriasis. LY3361237 will be administered by injections just under the skin. The study will last up to 41 weeks and may include up to 15 visits to the study center.

Official Title
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A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Participants With Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: LY3361237
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 Criteria: Have had certain types of infection within the last six months Have a clinically significant active infection, or recent acute active infection within the last 30 days Have other serious or unstable illnesses Have a history of organ or bone marrow transplant Have received any live vaccine within the last 4 weeks prior to screening Have received systemic nonbiologic psoriasis therapy within 4 weeks prior to study day 1 Have received topical psoriasis treatment within 14 days prior to study day 1 Have excessive skin exposure or use tanning booths for at least 4 weeks prior to study day 1

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3361237<br>LY3361237 administered subcutaneously (SC). | Drug: LY3361237<br>* Administered SC<br>|
| Placebo Comparator: Placebo<br>Placebo administered SC. | Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Day 253 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of LY3361237 During the Dosing Interval | PK: Cmin of LY3361237 During the Dosing Interval | Day 1 predose through Day 253 |