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| ID | Type | Description | Link |
|---|---|---|---|
| I7P-MC-DSAB | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to investigate the safety and tolerability of the study drug known as LY3041658 in participants with certain types of skin diseases. The study will measure how the body absorbs, breaks down and gets rid of LY3041658. It will last about 127 days for each participant, not including screening. This study is for research purposes only, and is not intended to treat any medical condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3041658 | Experimental | LY3041658 administered intravenously (IV) once every two weeks over 6 weeks (four doses). |
|
| Placebo | Placebo Comparator | Placebo administered IV once every two weeks over 6 weeks (four doses). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3041658 | Drug | Administered IV. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Dosing Day 1 through Day 127 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658 | Dosing Day 1 through Day 127 | |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) During Dosing Interval at Steady State (AUCss) of LY3041658 | Dosing Day 1 through Day 127 |
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Inclusion Criteria:
Exclusion Criteria:
- Have other skin diseases that may interfere with evaluation of the specified skin disease being studied.
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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 |
|---|---|---|---|---|---|---|
| Parexel Early Phase Unit at Glendale | Glendale | California | 91206-4140 | United States | ||
| Dawes Fretzin Clinical Research |
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| Label | URL |
|---|---|
| Click here for more information about this study: A Study of LY3041658 in Participants With Skin Diseases | View source |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D017444 | Skin Diseases, Papulosquamous |
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| Drug |
Administered IV. |
|
| Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3041658 | Dosing Day 1 through Day 127 |
| Indianapolis |
| Indiana |
| 46256 |
| United States |
| PAREXEL-Phase 1 Baltimore Harbor Hospital Center | Baltimore | Maryland | 21225 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |