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NCT Number: NCT07533006

A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)

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.

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kelowna Health and Memory Centre, Kelowna, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4005130

Drug

Administered IV

Placebo

Drug

Administered IV

Primary outcomes

  1. Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20

    Time frame: Week 24

Secondary outcomes

  1. Percentage of Participants Achieving At Least 50 Percent (%) Improvement from Baseline (SALT50)

    Time frame: Week 24

  2. Pharmacokinetics (PK): Trough Concentrations of LY4005130

    Time frame: Baseline Through Week 20

  3. Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Scalp Biopsy

    Time frame: Baseline, Week 24

    Scalp Biopsy

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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