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

NCT07533006

RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Alopecia Areata

Interventions: LY4005130, Placebo

Countries: United States, Canada, China, Netherlands, Poland, South Korea, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 50 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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
Locations (30)
  • Fremont, California, United States
  • Northridge, California, United States
  • Santa Clarita, California, United States
  • Cutler Bay, Florida, United States
  • Boston, Massachusetts, United States
  • Troy, Michigan, United States
  • Portsmouth, New Hampshire, United States
  • San Antonio, Texas, United States
  • South Jordan, Utah, United States
  • Kelowna, Canada
  • Newmarket, Canada
  • Ottawa, Canada
  • Verdun, Canada
  • Beijing, China
  • Shanghai, China
  • Shanghai, China
  • Tianjin, China
  • Rotterdam, Netherlands
  • Gdansk, Poland
  • Krakow, Poland
  • Ostrowiec Świętokrzyski, Poland
  • Wroclaw, Poland
  • Dongjak-gu, South Korea
  • Incheon, South Korea
  • Jeonju, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • London, United Kingdom
  • London, United Kingdom
  • Salford, United Kingdom