LY4005130 for adults with severe alopecia areata (hair loss)
Official title: 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
Run by Eli Lilly and Company · NCT07533006 · Data updated 2026-11-12
This trial tests whether intravenous LY4005130 helps adults with severe alopecia areata regrow scalp hair compared with placebo while monitoring safety and side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 65 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 30 sites (Fremont, California and 29 other locations) |
| Status | Recruiting |
| Started | April 14, 2026 |
| Main results expected | June 2027 |
| Study ends | October 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07533006 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with severe alopecia areata who have 50–90% scalp hair loss by SALT score, a current episode lasting between 6 months and 4 years, and who agree not to use other AA treatments during the study.
✕Probably not a fit
People with primarily diffuse or other non-alopecia areata hair loss, those who previously used oral JAK inhibitors, or those with unstable serious medical conditions are unlikely to be eligible or to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial compares intravenous LY4005130 with placebo in adults who have severe alopecia areata. Participants receive the study drug or placebo and are followed for roughly 48 weeks including screening, with periodic clinic visits and blood tests to measure how the body processes the drug and how the drug affects the body. Eligible participants have 50–90% scalp hair loss by SALT score with a current episode lasting 6 months to 4 years and must avoid other alopecia areata treatments during the study. The trial is sponsored by Eli Lilly and conducted at three clinical research centers in California.
Why it matters
Potential benefit: If effective, LY4005130 could help people with severe alopecia areata regain scalp hair and provide a new treatment option.
How similar studies have gone: Other agents, especially oral JAK inhibitors, have shown promise for alopecia areata in prior studies, but LY4005130 is a different investigational drug that has not yet been proven effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 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
Where it's running
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Center For Dermatology Clinical Research, Inc.
Fremont, California, United States Recruiting -
Northridge Clinical Trials
Northridge, California, United States Recruiting -
Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway
Santa Clarita, California, United States Recruiting -
Health Clinical Research, LLC
Cutler Bay, Florida, United States Recruiting -
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
Revival Research Institute, LLC
Troy, Michigan, United States Recruiting
Show 24 more locations
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Stracskin
Portsmouth, New Hampshire, United States Recruiting -
Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
San Antonio, Texas, United States Recruiting -
Jordan Valley Dermatology & Research Center
South Jordan, Utah, United States Recruiting -
Kelowna Health and Memory Centre
Kelowna, Canada Recruiting -
Ryan Clinical Research Inc.
Newmarket, Canada Recruiting -
Dar Clinical Research - Ottawa - Hunt Club Road
Ottawa, Canada Recruiting -
SIMa Recherche
Verdun, Canada Recruiting -
Beijing Friendship Hospital Affiliate of Capital University
Beijing, China Recruiting -
Huashan Hospital, Fudan University
Shanghai, China Recruiting -
Shanghai Skin Disease Hospital
Shanghai, China Recruiting -
Tianjin Medical University General Hospital
Tianjin, China Recruiting -
Erasmus Medisch Centrum
Rotterdam, Netherlands Recruiting -
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Poland Recruiting -
Diamond Clinic
Krakow, Poland Recruiting -
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Poland Recruiting -
Centrum Medyczne Ginemedica
Wroclaw, Poland Recruiting -
Chung-Ang University Hospital
Dongjak-gu, South Korea Recruiting -
Inha University Hospital
Incheon, South Korea Recruiting -
Jeonbuk National University Hospital
Jeonju, South Korea Recruiting -
Seoul National University Hospital
Seoul, South Korea Recruiting -
Kyung Hee University Hospital at Gangdong
Seoul, South Korea Recruiting -
Royal London Hospital
London, United Kingdom Recruiting -
Chelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom Recruiting -
Salford Royal Hospital
Salford, United Kingdom Recruiting
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
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Red Ultraviolet Hair Imaging and Hair Growth in Alopecia Areata
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.