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| ID | Type | Description | Link |
|---|---|---|---|
| J5D-MC-FPAD | Other Identifier | Eli Lilly and Company | |
| 2025-524726-18-00 | Other Identifier | EU Trial (CTIS) Number |
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The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in participants with non-segmental vitiligo (NSV) when compared with placebo. The study drug will be administered intravenously (IV) (into a vein in the arm).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
The study will last approximately 48 weeks, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4005130 | Experimental | LY4005130 administered intravenously (IV) |
|
| Placebo | Placebo Comparator | Placebo administered IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4005130 | Drug | Administered IV |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI) 75 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 75 | Week 24 | |
| Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Skin Biopsy | Baseline, Week 24 |
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Inclusion Criteria:
Eligible participants must have the following at both screening and baseline:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialists | Recruiting | Phoenix | Arizona | 85006 | United States |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication or approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Drug |
Administered IV |
|
| Pharmacokinetics (PK): Observed Trough of LY4005130 Serum Concentration | Week 24 |
| Saguaro Dermatology - Phoenix | Not yet recruiting | Phoenix | Arizona | 85008 | United States |
|
| Center For Dermatology Clinical Research, Inc. | Recruiting | Fremont | California | 94538 | United States |
|
| Northridge Clinical Trials | Recruiting | Northridge | California | 91325 | United States |
|
| Cura Clinical Research - Oxnard | Recruiting | Oxnard | California | 93030 | United States |
|
| Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway | Not yet recruiting | Santa Clarita | California | 91355 | United States |
|
| Health Clinical Research, LLC | Recruiting | Miami | Florida | 33189 | United States |
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| K2 Medical Research - Tampa | Recruiting | Tampa | Florida | 33634 | United States |
|
| Advanced Medical Research, PC. | Recruiting | Sandy Springs | Georgia | 30328 | United States |
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| Dawes Fretzin Clinical Research Group, LLC | Recruiting | Indianapolis | Indiana | 46250 | United States |
|
| Brigham and Women's Hospital | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
|
| Revival Research Institute, LLC | Recruiting | Troy | Michigan | 48084 | United States |
|
| Stracskin | Recruiting | Portsmouth | New Hampshire | 03801 | United States |
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| Equity Medical | Recruiting | The Bronx | New York | 10455 | United States |
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| Accurate Clinical Research, Inc | Recruiting | Humble | Texas | 77346 | United States |
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| Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue | Recruiting | San Antonio | Texas | 78235 | United States |
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| Jordan Valley Dermatology & Research Center | Recruiting | South Jordan | Utah | 84095 | United States |
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| Clinical Research Partners, LLC | Recruiting | Richmond | Virginia | 23226 | United States |
|
| Anima Diepenbeek | Not yet recruiting | Diepenbeek | 3590 | Belgium |
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| UZ Gent | Not yet recruiting | Ghent | 9000 | Belgium |
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| Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman | Not yet recruiting | Liège | 4000 | Belgium |
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| INTERMED Groupe Sante | Recruiting | Chicoutimi | G7H 7Y8 | Canada |
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| DermEffects | Not yet recruiting | London | N6H 5L5 | Canada |
|
| Dar Clinical Research - Ottawa - Hunt Club Road | Recruiting | Ottawa | K1V 1C1 | Canada |
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| The Centre for Dermatology | Not yet recruiting | Richmond Hill | L4B 1A5 | Canada |
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| Research Toronto | Not yet recruiting | Toronto | M4W 2N4 | Canada |
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| SIMa Recherche | Not yet recruiting | Verdun | H4G 2L8 | Canada |
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| Peking University People's Hospital | Not yet recruiting | Beijing | 100034 | China |
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| Hangzhou Third People's Hospital | Not yet recruiting | Hangzhou | 310009 | China |
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| Shanghai Skin Disease Hospital | Not yet recruiting | Shanghai | 200071 | China |
|
| The University of Hong Kong-Shenzhen Hospital | Not yet recruiting | Shenzhen | 518053 | China |
|
| Centrum Badan Klinicznych PI-House sp. z o.o. | Not yet recruiting | Gdansk | 80-546 | Poland |
|
| Diamond Clinic | Not yet recruiting | Krakow | 31-559 | Poland |
|
| Dermedic Jacek Zdybski | Not yet recruiting | Ostrowiec Świętokrzyski | 27-400 | Poland |
|
| Centrum Medyczne Ginemedica | Not yet recruiting | Wroclaw | 50-414 | Poland |
|
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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