Recruiting
Phase 2

LY4005130

Sponsor:

Eli Lilly and Company

Code:

NCT07533006

Conditions

Alopecia Areata

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

LY4005130

Placebo

Study Details

Brief 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.

Conditions

Alopecia Areata

Study ID

NCT07533006

Start date

Apr 14, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LY4005130

LY4005130 administered intravenously (IV)

placebo comparator: Placebo

Placebo administered IV

Interventions

LY4005130

Administered IV

Placebo

Administered IV

Primary outcome measure

  • Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20 [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Center For Dermatology Clinical Research, Inc.

Recruiting

Fremont, California, United States, 94538

Contacts

510-797-0140

Principal Investigator:

Sunil Dhawan

Northridge Clinical Trials

Recruiting

Northridge, California, United States, 91325

Contacts

818-350-7482

Principal Investigator:

Navid Ezra

Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway

Recruiting

Santa Clarita, California, United States, 91355

Contacts

833-525-2872

Principal Investigator:

Bernard Raskin

Health Clinical Research, LLC

Recruiting

Cutler Bay, Florida, United States, 33189

Contacts

786-280-1977

Principal Investigator:

Soroush Aghigh

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

617-732-4918

Principal Investigator:

Arash Mostaghimi

Revival Research Institute, LLC

Recruiting

Troy, Michigan, United States, 48084

Contacts

248-590-0298

Principal Investigator:

Ali Moiin

Stracskin

Recruiting

Portsmouth, New Hampshire, United States, 03801

Contacts

617-833-9995

Principal Investigator:

Abel Jarell

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

Recruiting

San Antonio, Texas, United States, 78235

Contacts

210-852-2779

Principal Investigator:

John Browning

Jordan Valley Dermatology & Research Center

Recruiting

South Jordan, Utah, United States, 84095

Principal Investigator:

Douglass Forsha

Kelowna Health and Memory Centre

Recruiting

Kelowna, Canada, V1Y 5A8

Principal Investigator:

Nicola Gray

Ryan Clinical Research Inc.

Recruiting

Newmarket, Canada, L3Y 5G8

Contacts

905-235-5232

Principal Investigator:

Sanjay Siddha

Dar Clinical Research - Ottawa - Hunt Club Road

Recruiting

Ottawa, Canada, K1V 1C1

Principal Investigator:

Reetesh Bose

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-08.