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

May 20, 2026 updated by: Eli Lilly and Company

A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants With Severe Alopecia Areata

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Canada
      • Kelowna, Canada, V1Y 5A8
        • Not yet recruiting
        • Kelowna Health and Memory Centre
        • Principal Investigator:
          • Nicola Gray
      • Newmarket, Canada, L3Y 5G8
        • Not yet recruiting
        • Ryan Clinical Research Inc.
        • Principal Investigator:
          • Sanjay Siddha
        • Contact:
          • Phone Number: 905-235-5232
      • Ottawa, Canada, K1V 1C1
        • Not yet recruiting
        • Dar Clinical Research - Ottawa - Hunt Club Road
        • Principal Investigator:
          • Reetesh Bose
      • Verdun, Canada, H4G 2L8
        • Not yet recruiting
        • Sima Recherche
        • Contact:
          • Phone Number: 5147308398
        • Principal Investigator:
          • Simon Nigen
  • China
      • Beijing, China, 100050
        • Not yet recruiting
        • Beijing Friendship Hospital Affiliate of Capital University
        • Principal Investigator:
          • Fenglin Zhuo
      • Shanghai, China, 200040
        • Not yet recruiting
        • Huashan Hospital, Fudan University
        • Principal Investigator:
          • Wenyu Wu
      • Shanghai, China, 200071
        • Not yet recruiting
        • Shanghai Skin Disease Hospital
        • Principal Investigator:
          • Yuling Shi
      • Tianjin, China, 300052
        • Not yet recruiting
        • Tianjin Medical University General Hospital
        • Principal Investigator:
          • Huiping Wang
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Not yet recruiting
        • Erasmus Medisch Centrum
        • Contact:
          • Phone Number: 0647074229
        • Principal Investigator:
          • Rick Waalboer-Spuij
  • Poland
      • Gdansk, Poland, 80-546
        • Not yet recruiting
        • Centrum Badan Klinicznych PI-House Sp. z o.o.
        • Contact:
          • Phone Number: 48513104911
        • Principal Investigator:
          • Aleksandra Okuniewska
      • Krakow, Poland, 31-559
        • Not yet recruiting
        • Diamond Clinic
        • Principal Investigator:
          • Barbara Rewerska
        • Contact:
          • Phone Number: + 48 696 049 029
      • Ostrowiec Świętokrzyski, Poland, 27-400
        • Not yet recruiting
        • Dermedic Jacek Zdybski
        • Principal Investigator:
          • Jacek Zdybski
        • Contact:
          • Phone Number: 786643111
      • Wroclaw, Poland, 50-414
        • Not yet recruiting
        • Centrum Medyczne Ginemedica
        • Principal Investigator:
          • Justyna Kwapisz
  • South Korea
      • Dongjak-gu, South Korea, 06973
        • Not yet recruiting
        • Chung-Ang University Hospital
        • Principal Investigator:
          • Beomjoon Kim
      • Incheon, South Korea, 22332
        • Not yet recruiting
        • Inha University Hospital
        • Principal Investigator:
          • Gwang Seong Choi
      • Jeonju, South Korea, 54907
        • Not yet recruiting
        • Jeonbuk National University Hospital
        • Principal Investigator:
          • Jin Park
        • Contact:
          • Phone Number: 01033118402
      • Seoul, South Korea, 03080
        • Not yet recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • OHSANG KWON
      • Seoul, South Korea, 05278
        • Not yet recruiting
        • Kyung Hee University Hospital at Gangdong
        • Principal Investigator:
          • Bark Lynn Lew
  • United Kingdom
      • London, United Kingdom, SW10 9NH
        • Not yet recruiting
        • Chelsea and Westminster Hospital NHS Foundation Trust
        • Principal Investigator:
          • Leila Asfour
      • London, United Kingdom, E1 1FR
        • Not yet recruiting
        • Royal London Hospital
        • Principal Investigator:
          • Maria Angeliki Gkini
      • Salford, United Kingdom, M6 8HD
        • Not yet recruiting
        • Salford Royal Hospital
        • Principal Investigator:
          • Matthew Harries
  • United States
    • California
      • Fremont, California, United States, 94538
        • Recruiting
        • Center For Dermatology Clinical Research, Inc.
        • Principal Investigator:
          • Sunil Dhawan
        • Contact:
          • Phone Number: 510-797-0140
      • Northridge, California, United States, 91325
        • Recruiting
        • Northridge Clinical Trials
        • Principal Investigator:
          • Navid Ezra
        • Contact:
          • Phone Number: 818-350-7482
      • Santa Clarita, California, United States, 91355
        • Not yet recruiting
        • Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway
        • Contact:
          • Phone Number: 833-525-2872
        • Principal Investigator:
          • Bernard Raskin
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Health Clinical Research, LLC
        • Principal Investigator:
          • Soroush Aghigh
        • Contact:
          • Phone Number: 786-280-1977
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Arash Mostaghimi
        • Contact:
          • Phone Number: 617-732-4918
    • Michigan
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Revival Research Institute, LLC
        • Principal Investigator:
          • Ali Moiin
        • Contact:
          • Phone Number: 248-590-0298
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Recruiting
        • StracSkin
        • Principal Investigator:
          • Abel Jarell
        • Contact:
          • Phone Number: 617-833-9995
    • Texas
      • San Antonio, Texas, United States, 78235
        • Recruiting
        • Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
        • Contact:
          • Phone Number: 210-852-2779
        • Principal Investigator:
          • John Browning
    • Utah
      • South Jordan, Utah, United States, 84095
        • Recruiting
        • Jordan Valley Dermatology & Research Center
        • Principal Investigator:
          • Douglass Forsha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered IV
Drug: Placebo
Administered IV
Experimental: LY4005130
LY4005130 administered intravenously (IV)
Drug: LY4005130
Administered IV

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving At Least 50 Percent (%) Improvement from Baseline (SALT50)
Time Frame: Week 24
Week 24
Pharmacokinetics (PK): Trough Concentrations of LY4005130
Time Frame: Baseline Through Week 20
Baseline Through Week 20
Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Scalp Biopsy
Time Frame: Baseline, Week 24
Scalp Biopsy
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27772
  • J5D-MC-FPAC (Other Identifier: Eli Lilly and Company)
  • 2025-524727-41-00 (Other Identifier: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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