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NCT07533006PHASE2Recruiting

A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)

Eli Lilly and Company

Start Date

4/14/2026

Completion Date

10/1/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to 50 years

Inclusion Criteria: * Have severe Alopecia Areata (AA) that meets all of the following criteria: * Hair loss encompassing ≥50% and ≤90% of the scalp, as measured by Severity of Alopecia Tool (SALT) score * The duration of the current episode of severe AA is at least 6 months and does not exceed 4 years * No significant spontaneous hair regrowth in the investigator's opinion for at least 6 months * Agree not to use any AA treatments during the study Exclusion Criteria: * Primarily "diffuse" type of AA (characterized by diffuse hair shedding) * Are currently experiencing other forms of alopecia * Participants who, in the opinion of the investigator, are currently experiencing or have a history of unstable concomitant disease that requires frequent hospitalizations, and/or frequent use of systemic immunosuppressants that may interfere with participation in the study * Have received oral JAK Inhibitors in the past * Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study * Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness

Interventions

DRUG

LY4005130

DRUG

Placebo

Interested in This Trial?

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Conditions

Alopecia Areata

Locations

Center For Dermatology Clinical Research, Inc.

Fremont, California 94538

United States

Northridge Clinical Trials

Northridge, California 91325

United States

Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway

Santa Clarita, California 91355

United States

Health Clinical Research, LLC

Cutler Bay, Florida 33189

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Revival Research Institute, LLC

Troy, Michigan 48084

United States

Stracskin

Portsmouth, New Hampshire 03801

United States

Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue

San Antonio, Texas 78235

United States

Jordan Valley Dermatology & Research Center

South Jordan, Utah 84095

United States

Kelowna Health and Memory Centre

Kelowna, V1Y 5A8

Canada

Ryan Clinical Research Inc.

Newmarket, L3Y 5G8

Canada

Dar Clinical Research - Ottawa - Hunt Club Road

Ottawa, K1V 1C1

Canada

SIMa Recherche

Verdun, H4G 2L8

Canada

Beijing Friendship Hospital Affiliate of Capital University

Beijing, 100050

China

Huashan Hospital, Fudan University

Shanghai, 200040

China

Shanghai Skin Disease Hospital

Shanghai, 200071

China

Tianjin Medical University General Hospital

Tianjin, 300052

China

Erasmus Medisch Centrum

Rotterdam, 3015 GD

Netherlands

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, 80-546

Poland

Diamond Clinic

Krakow, 31-559

Poland

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, 27-400

Poland

Centrum Medyczne Ginemedica

Wroclaw, 50-414

Poland

Chung-Ang University Hospital

Dongjak-gu, 06973

South Korea

Inha University Hospital

Incheon, 22332

South Korea

Jeonbuk National University Hospital

Jeonju, 54907

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Kyung Hee University Hospital at Gangdong

Seoul, 05278

South Korea

Royal London Hospital

London, E1 1FR

United Kingdom

Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 9NH

United Kingdom

Salford Royal Hospital

Salford, M6 8HD

United Kingdom