Clinical trial Recruiting at 30 sites Phase 2 Interventional Ages 18 to 60

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.

More Alopecia Areata trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment65 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Locations30 sites (Fremont, California and 29 other locations)
StatusRecruiting
StartedApril 14, 2026
Main results expectedJune 2027
Study endsOctober 2027
Registry record updatedNovember 4, 2026
Trial IDNCT07533006 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Which works better for patchy hair loss: steroid injections or microneedling with steroid cream?

    This trial tests whether injecting triamcinolone into the skin or using microneedling with topical triamcinolone helps people with alopecia areata regrow hair more effectively.

    Recruiting Phase 4 Dow University of Health Sciences · Karachi, Sindh · NCT07926711

  • Red Ultraviolet Hair Imaging and Hair Growth in Alopecia Areata

    This observational study checks if red fluorescence seen with UV hair imaging relates to disease features and how well hair regrows after standard intralesional corticosteroid treatment in adults with limited plaque-type alopecia areata.

    Recruiting Istanbul Training and Research Hospital · Istanbul · NCT07803874

  • VC005 tablets in teens with severe alopecia areata

    This Phase 1 study tests VC005 tablets in adolescents with severe alopecia areata to see how the drug behaves in the body, whether it is safe, and if there are signs of benefit.

    Recruiting Phase 1 Jiangsu vcare pharmaceutical technology co., LTD · Beijing, Beijing Municipality · NCT07762443

  • VC005 tablets in severe alopecia areata

    This study tests whether VC005 tablets work better than a placebo for adults with severe alopecia areata.

    Recruiting Phase 2 Jiangsu vcare pharmaceutical technology co., LTD · Beijing, Beijing Municipality · NCT07749716

  • Ritlecitinib for patchy hair loss in teens and adults with alopecia areata

    This study tests whether ritlecitinib can help people 12 and older with patchy alopecia areata who have had symptoms for 6 months to 10 years.

    Recruiting at 30 sites Phase 3 Pfizer · Encinitas, California and 37 other locations · NCT07733765

  • Alopecia Areata: looking at ferroptosis markers in blood

    This study tests whether levels of GPX4 and MDA in blood differ between people with alopecia areata and healthy controls.

    Recruiting Istanbul Training and Research Hospital · Istanbul, Cerrahpasa Mahallesi · NCT07733063

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.