A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis

Study Overview
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Brief Summary
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This study is being conducted to determine how safe and how well tolerated LY3462817 is when given to participants with psoriasis. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. The study will last up to one year and one month for each participant. As part of protocol addendum, this study is additionally evaluating the safety and tolerability of LY3509754 in participants with psoriasis. Blood tests will be done to check how much LY3509754 is in the bloodstream and how long the body takes to get rid of it. The addendum will last up to 12 weeks for each participant.

Official Title
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A Multiple-Dose, Randomized, Placebo-Controlled, Study of LY3462817 or LY3509754 in Patients With Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: LY3462817 - IV
* Drug: LY3462817 - SC
* Drug: Placebo - IV
* Drug: Placebo - SC
* Drug: LY3509754
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have been diagnosed with psoriasis for at least 6 months Participants must have active psoriasis plaques Participants must be willing and able to have skin biopsies (small samples of skin removed for testing) Exclusion Criteria: Participants must not have received certain medications for psoriasis that are applied to the skin within 14 days prior to baseline (Day 1) Participants must not have received certain oral or injectable medications or light therapy for psoriasis within 4 weeks prior to baseline

Ages Eligible for Study
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Minimum Age: 18 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: LY3462817 - Intravenous (IV)<br>LY3462817 administered as IV infusions. | Drug: LY3462817 - IV<br>* Administered IV<br>|
| Placebo Comparator: Placebo - IV<br>Placebo administered as IV infusions. | Drug: Placebo - IV<br>* Administered IV<br>|
| Experimental: LY3462817 - Subcutaneous (SC)<br>LY3462817 administered as SC injections. (SC administration is discretionary/optional.) | Drug: LY3462817 - SC<br>* Administered SC<br>|
| Placebo Comparator: Placebo - SC<br>Placebo administered as SC injections. (SC administration is discretionary/optional.) | Drug: Placebo - SC<br>* Administered SC<br>|
| Experimental: LY3509754<br>LY3509754 administered orally. | Drug: LY3509754<br>* Administered orally.<br>|
| Placebo Comparator: Placebo<br>Placebo administered orally. | Drug: Placebo<br>* Administered orally.<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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to LY3462817 and LY3509754 | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Average Concentration (Cave) of LY3462817 and LY3509754 | PK: Cave of LY3462817 and LY3509754 | Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754) |