A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)
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
3 other identifiers
interventional
60
7 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2026
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2026
CompletedStudy Start
First participant enrolled
April 14, 2026
CompletedFirst Posted
Study publicly available on registry
April 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
June 4, 2026
June 1, 2026
1.1 years
April 9, 2026
June 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20
Week 24
Secondary Outcomes (3)
Percentage of Participants Achieving At Least 50 Percent (%) Improvement from Baseline (SALT50)
Week 24
Pharmacokinetics (PK): Trough Concentrations of LY4005130
Baseline Through Week 20
Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Scalp Biopsy
Baseline, Week 24
Study Arms (2)
LY4005130
EXPERIMENTALLY4005130 administered intravenously (IV)
Placebo
PLACEBO COMPARATORPlacebo administered IV
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Northridge Clinical Trials
Northridge, California, 91325, United States
Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway
Santa Clarita, California, 91355, United States
Health Clinical Research, LLC
Cutler Bay, Florida, 33189, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Revival Research Institute, LLC
Troy, Michigan, 48084, United States
Stracskin
Portsmouth, New Hampshire, 03801, United States
Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
San Antonio, Texas, 78235, United States
Jordan Valley Dermatology & Research Center
South Jordan, Utah, 84095, United States
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8, Canada
Ryan Clinical Research Inc.
Newmarket, L3Y 5G8, Canada
Dar Clinical Research - Ottawa - Hunt Club Road
Ottawa, K1V 1C1, Canada
SIMa Recherche
Verdun, H4G 2L8, Canada
Beijing Friendship Hospital Affiliate of Capital University
Beijing, 100050, China
Huashan Hospital, Fudan University
Shanghai, 200040, China
Shanghai Skin Disease Hospital
Shanghai, 200071, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546, Poland
Diamond Clinic
Krakow, 31-559, Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, 27-400, Poland
Centrum Medyczne Ginemedica
Wroclaw, 50-414, Poland
Chung-Ang University Hospital
Dongjak-gu, 06973, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Jeonbuk National University Hospital
Jeonju, 54907, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, 05278, South Korea
Royal London Hospital
London, E1 1FR, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH, United Kingdom
Salford Royal Hospital
Salford, M6 8HD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2026
First Posted
April 16, 2026
Study Start
April 14, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
June 4, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.