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| ID | Type | Description | Link |
|---|---|---|---|
| J5D-MC-FPAC | Other Identifier | Eli Lilly and Company | |
| 2025-524727-41-00 | Other Identifier | EU Trial (CTIS) Number |
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The purpose of this study is to evaluate how well LY4005130 works in participants with severe alopecia areata (hair loss) when compared with placebo, and how well it's tolerated and what side effects may occur. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
The study drug will be administered intravenously (IV) (into a vein in the arm).
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 an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving At Least 50 Percent (%) Improvement from Baseline (SALT50) | Week 24 | |
| Pharmacokinetics (PK): Trough Concentrations of LY4005130 | Baseline Through Week 20 | |
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Inclusion Criteria:
Have severe Alopecia Areata (AA) that meets all of the following criteria:
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 |
|---|---|---|---|---|---|---|
| Center For Dermatology Clinical Research, Inc. | Recruiting | Fremont | California | 94538 | 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 |
|
| Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Scalp Biopsy |
Scalp Biopsy |
| Baseline, Week 24 |
| Northridge Clinical Trials | Recruiting | Northridge | California | 91325 | United States |
|
| Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway | Not yet recruiting | Santa Clarita | California | 91355 | United States |
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| Health Clinical Research, LLC | Recruiting | Cutler Bay | Florida | 33189 | United States |
|
| Brigham and Women's Hospital | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
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| Revival Research Institute, LLC | Recruiting | Troy | Michigan | 48084 | United States |
|
| Stracskin | Recruiting | Portsmouth | New Hampshire | 03801 | United States |
|
| Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue | Recruiting | San Antonio | Texas | 78235 | United States |
|
| Jordan Valley Dermatology & Research Center | Recruiting | South Jordan | Utah | 84095 | United States |
|
| Kelowna Health and Memory Centre | Recruiting | Kelowna | V1Y 5A8 | Canada |
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| Ryan Clinical Research Inc. | Not yet recruiting | Newmarket | L3Y 5G8 | Canada |
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| Dar Clinical Research - Ottawa - Hunt Club Road | Recruiting | Ottawa | K1V 1C1 | Canada |
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| SIMa Recherche | Not yet recruiting | Verdun | H4G 2L8 | Canada |
|
| Beijing Friendship Hospital Affiliate of Capital University | Not yet recruiting | Beijing | 100050 | China |
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| Huashan Hospital, Fudan University | Not yet recruiting | Shanghai | 200040 | China |
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| Shanghai Skin Disease Hospital | Not yet recruiting | Shanghai | 200071 | China |
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| Tianjin Medical University General Hospital | Not yet recruiting | Tianjin | 300052 | China |
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| Erasmus Medisch Centrum | Not yet recruiting | Rotterdam | 3015 GD | Netherlands |
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| Centrum Badan Klinicznych PI-House sp. z o.o. | Not yet recruiting | Gdansk | 80-546 | Poland |
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| Diamond Clinic | Not yet recruiting | Krakow | 31-559 | Poland |
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| Dermedic Jacek Zdybski | Not yet recruiting | Ostrowiec Świętokrzyski | 27-400 | Poland |
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| Centrum Medyczne Ginemedica | Not yet recruiting | Wroclaw | 50-414 | Poland |
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| Chung-Ang University Hospital | Not yet recruiting | Dongjak-gu | 06973 | South Korea |
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| Inha University Hospital | Not yet recruiting | Incheon | 22332 | South Korea |
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| Jeonbuk National University Hospital | Not yet recruiting | Jeonju | 54907 | South Korea |
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| Seoul National University Hospital | Not yet recruiting | Seoul | 03080 | South Korea |
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| Kyung Hee University Hospital at Gangdong | Not yet recruiting | Seoul | 05278 | South Korea |
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| Royal London Hospital | Not yet recruiting | London | E1 1FR | United Kingdom |
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| Chelsea and Westminster Hospital NHS Foundation Trust | Not yet recruiting | London | SW10 9NH | United Kingdom |
|
| Salford Royal Hospital | Not yet recruiting | Salford | M6 8HD | United Kingdom |
|
| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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