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| ID | Type | Description | Link |
|---|---|---|---|
| J1A-MC-KDAC | Other Identifier | Eli Lilly and Company |
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Terminated due to liver findings
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3462817 - Intravenous (IV) | Experimental | LY3462817 administered as IV infusions. |
|
| Placebo - IV | Placebo Comparator | Placebo administered as IV infusions. |
|
| LY3462817 - Subcutaneous (SC) | Experimental | LY3462817 administered as SC injections. (SC administration is discretionary/optional.) |
|
| Placebo - SC | Placebo Comparator | Placebo administered as SC injections. (SC administration is discretionary/optional.) |
|
| LY3509754 | Experimental | LY3509754 administered orally. |
|
| Placebo | Placebo Comparator | Placebo administered orally. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3462817 - IV | Drug | Administered IV |
| |
| LY3462817 - SC |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Associates - Los Angeles | Los Angeles | California | 90045 | United States | ||
| Miami Dermatology and Laser Research |
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| Label | URL |
|---|---|
| A Safety Study of LY3462817 in Participants With Psoriasis | View source |
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| Drug |
Administered SC |
|
| Placebo - IV | Drug | Administered IV |
|
| Placebo - SC | Drug | Administered SC |
|
| LY3509754 | Drug | Administered orally. |
|
| Placebo | Drug | Administered orally. |
|
| Miami |
| Florida |
| 33173 |
| United States |
| Advanced Pharma Clinical Research | Miami | Florida | 33175 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613-1244 | United States |
| Avita Clinical Research | Tampa | Florida | 33613 | United States |
| Meridian Clinical Research | Baton Rouge | Louisiana | 70808 | United States |
| DermDox Centers for Dermatology | Hazleton | Pennsylvania | 18201 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Simcoderm Medical & Surgical Dermatology Centre | Barrie | Ontario | L4M 7G1 | Canada |
| Skin Health | Cobourg | Ontario | K9A 0Z4 | Canada |
| K. Papp Clinical Research | Waterloo | Ontario | N2J 1C4 | Canada |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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