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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT07533006

Registry updated: 2026-10-09
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Description

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.

Interventions

  • LY4005130 (Drug)
    Administered IV
  • Placebo (Drug)
    Administered IV

Eligibility criteria

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 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

Conditions

Alopecia Areata

Locations

  • Center For Dermatology Clinical Research, Inc. — Fremont, California, United States
  • Northridge Clinical Trials — Northridge, California, United States
  • Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway — Santa Clarita, California, United States
  • Health Clinical Research, LLC — Cutler Bay, Florida, United States
  • Brigham and Women's Hospital — Boston, Massachusetts, United States
  • Revival Research Institute, LLC — Troy, Michigan, United States
  • Stracskin — Portsmouth, New Hampshire, United States
  • Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue — San Antonio, Texas, United States
  • Jordan Valley Dermatology & Research Center — South Jordan, Utah, United States
  • Kelowna Health and Memory Centre — Kelowna, Canada
  • Ryan Clinical Research Inc. — Newmarket, Canada
  • Dar Clinical Research - Ottawa - Hunt Club Road — Ottawa, Canada
  • SIMa Recherche — Verdun, Canada
  • Beijing Friendship Hospital Affiliate of Capital University — Beijing, China
  • Huashan Hospital, Fudan University — Shanghai, China
  • Shanghai Skin Disease Hospital — Shanghai, China
  • Tianjin Medical University General Hospital — Tianjin, China
  • Erasmus Medisch Centrum — Rotterdam, Netherlands
  • Centrum Badan Klinicznych PI-House sp. z o.o. — Gdansk, Poland
  • Diamond Clinic — Krakow, Poland
  • Dermedic Jacek Zdybski — Ostrowiec Świętokrzyski, Poland
  • Centrum Medyczne Ginemedica — Wroclaw, Poland
  • Chung-Ang University Hospital — Dongjak-gu, South Korea
  • Inha University Hospital — Incheon, South Korea
  • Jeonbuk National University Hospital — Jeonju, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Kyung Hee University Hospital at Gangdong — Seoul, South Korea
  • Royal London Hospital — London, United Kingdom
  • Chelsea and Westminster Hospital NHS Foundation Trust — London, United Kingdom
  • Salford Royal Hospital — Salford, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record