Actively Recruiting
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY4005130 in Adults With Severe Alopecia Areata
Led by Eli Lilly and Company · Updated on 2026-06-04
60
Participants Needed
30
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well LY4005130 works for adults with severe alopecia areata, a condition causing significant hair loss. This Phase 2 study compares LY4005130 with a placebo to assess its effects, how well participants tolerate it, and possible side effects. Blood tests will be used to understand how the body processes the drug and how the drug affects the body. Participants will receive either LY4005130 or a placebo through an intravenous (IV) infusion into a vein in the arm. The study is randomized, double-blind, and placebo-controlled to ensure unbiased results. The treatment period and overall study duration last about 48 weeks, including screening time. During the study, participants will undergo regular assessments including the Severity of Alopecia Tool (SALT) to measure hair loss improvement. Researchers will also monitor drug levels in the blood and changes in gene expression from scalp biopsies. The primary outcome is the percentage of participants achieving a SALT score of 20 or less by week 24. Safety and tolerability will be closely observed throughout the study.
CONDITIONS
Brief Title
A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 50 years
- Severe alopecia areata with 50% to 90% scalp hair loss measured by SALT score
- Current episode lasting at least 6 months and no more than 4 years
- No significant spontaneous hair regrowth for at least 6 months
- Agree not to use any alopecia areata treatments during the study
You will not qualify if you...
- Having primarily diffuse type of alopecia areata
- Experiencing other forms of alopecia
- History or current unstable disease requiring frequent hospitalizations or systemic immunosuppressants
- Previous use of oral JAK inhibitors
- Major surgery within 8 weeks before screening or planned during the study
- History or presence of serious cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, neuropsychiatric disorders, or other serious unstable illnesses
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive LY4005130 or placebo administered intravenously as part of the study treatment.
Regular visits during treatment period to receive intravenous administration and assessments
Trial Site Locations
Total: 30 locations
1
Center For Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
Actively Recruiting
2
Northridge Clinical Trials
Northridge, California, United States, 91325
Actively Recruiting
3
Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway
Santa Clarita, California, United States, 91355
Not Yet Recruiting
4
Health Clinical Research, LLC
Cutler Bay, Florida, United States, 33189
Actively Recruiting
5
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
6
Revival Research Institute, LLC
Troy, Michigan, United States, 48084
Actively Recruiting
7
Stracskin
Portsmouth, New Hampshire, United States, 03801
Actively Recruiting
8
Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
San Antonio, Texas, United States, 78235
Actively Recruiting
9
Jordan Valley Dermatology & Research Center
South Jordan, Utah, United States, 84095
Actively Recruiting
10
Kelowna Health and Memory Centre
Kelowna, Canada, V1Y 5A8
Not Yet Recruiting
11
Ryan Clinical Research Inc.
Newmarket, Canada, L3Y 5G8
Not Yet Recruiting
12
Dar Clinical Research - Ottawa - Hunt Club Road
Ottawa, Canada, K1V 1C1
Not Yet Recruiting
13
SIMa Recherche
Verdun, Canada, H4G 2L8
Not Yet Recruiting
14
Beijing Friendship Hospital Affiliate of Capital University
Beijing, China, 100050
Not Yet Recruiting
15
Huashan Hospital, Fudan University
Shanghai, China, 200040
Not Yet Recruiting
16
Shanghai Skin Disease Hospital
Shanghai, China, 200071
Not Yet Recruiting
17
Tianjin Medical University General Hospital
Tianjin, China, 300052
Not Yet Recruiting
18
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
19
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Poland, 80-546
Not Yet Recruiting
20
Diamond Clinic
Krakow, Poland, 31-559
Not Yet Recruiting
21
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Poland, 27-400
Not Yet Recruiting
22
Centrum Medyczne Ginemedica
Wroclaw, Poland, 50-414
Not Yet Recruiting
23
Chung-Ang University Hospital
Dongjak-gu, South Korea, 06973
Not Yet Recruiting
24
Inha University Hospital
Incheon, South Korea, 22332
Not Yet Recruiting
25
Jeonbuk National University Hospital
Jeonju, South Korea, 54907
Not Yet Recruiting
26
Seoul National University Hospital
Seoul, South Korea, 03080
Not Yet Recruiting
27
Kyung Hee University Hospital at Gangdong
Seoul, South Korea, 05278
Not Yet Recruiting
28
Royal London Hospital
London, United Kingdom, E1 1FR
Not Yet Recruiting
29
Chelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom, SW10 9NH
Not Yet Recruiting
30
Salford Royal Hospital
Salford, United Kingdom, M6 8HD
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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