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

June 3, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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
      • Cutler Bay, Florida, United States, 33189
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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