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LY4005130 for adults 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

Phase 2 Interventional Eli Lilly and Company · NCT07533006

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

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years to 50 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations29 sites (Fremont, California and 28 other locations)
Trial IDNCT07533006 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

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 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

Where this trial is running

Fremont, California and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alopecia Areata
Last reviewed 2026-06-10 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.