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| ID | Type | Description | Link |
|---|---|---|---|
| J1P-MC-KFAD | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The main purpose of this study is to learn more about the safety and side effects of LY3471851 when given by injection just under the skin to participants with eczema. The study will last up to 48 weeks and may include up to 23 visits to the study center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 µg/kg LY3471851 | Active Comparator | Participants received subcutaneous (SC) injection of 10 microgram per kilogram (μg/kg) LY3471851 every 2 weeks for a treatment period of 12 weeks. |
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| 12 µg/kg LY3471851 | Active Comparator | Participants received subcutaneous injection of 12 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks. |
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| 24 µg/kg LY3471851 | Active Comparator | Participants received subcutaneous injection of 24 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks. |
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| Placebo | Placebo Comparator | Participants received subcutaneous injection of placebo every 2 weeks for a treatment period of 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3471851 | Drug | Administered 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 Study Drug Administration | 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 Study Completion (up to Week 48) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851 | PK: AUC of LY3471851 | Postdose on Day 1 through Day 14 |
| PK: Trough Concentrations (Ctrough) of LY3471851 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Nektar Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Research Trials, LLC | North Little Rock | Arkansas | 72117 | United States | ||
| California Dermatology & Clinical Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39455575 | Derived | Silverberg JI, Rosmarin D, Chovatiya R, Bieber T, Schleicher S, Beck L, Gooderham M, Chaudhry S, Fanton C, Yu D, Levy J, Liu Y, Miyazaki T, Tagliaferri M, Schmitz C, Nirula A, Kotzin B, Zalevsky J. The regulatory T cell-selective interleukin-2 receptor agonist rezpegaldesleukin in the treatment of inflammatory skin diseases: two randomized, double-blind, placebo-controlled phase 1b trials. Nat Commun. 2024 Oct 25;15(1):9230. doi: 10.1038/s41467-024-53384-1. |
| Label | URL |
|---|---|
| A Study of LY3471851 in Participants With Eczema | View source |
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| Placebo | Drug | Administered SC |
|
PK: Ctrough of LY3471851
| Week 12 |
| PK: Maximum Concentration (Cmax) of LY3471851 | PK: Cmax of LY3471851 | Postdose on Day 1 through Day 14 |
| Encinitas |
| California |
| 92024 |
| United States |
| Center For Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States |
| Therapeutics Clinical Research | San Diego | California | 92123 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| Miami Dermatology and Laser Research | Miami | Florida | 33173 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613-1244 | United States |
| Medical Dermatology Specialists | Sandy Springs | Georgia | 30328 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| Skin Sciences | Louisville | Kentucky | 40217 | United States |
| Derm Center | Troy | Michigan | 48084 | United States |
| ActivMed Practices and Research | Portsmouth | New Hampshire | 03801 | United States |
| Remington-Davis, Inc | Columbus | Ohio | 43215 | United States |
| Unity Clinical Research | Oklahoma City | Oklahoma | 73118 | United States |
| Paddington Testing Company Inc | Philadelphia | Pennsylvania | 19103 | United States |
| DermDox Centers for Dermatology | Sugarloaf | Pennsylvania | 18249 | United States |
| Studies in Dermatology, LLC | Cypress | Texas | 77433 | United States |
| Rodgers Dermatology | Frisco | Texas | 75034 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Complete Dermatology | Sugar Land | Texas | 77478 | United States |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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