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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY4005130 		LY4005130 administered intravenously (IV)
  • Drug: LY4005130
    Administered IV
Placebo Comparator
Placebo 		Placebo administered IV
  • Drug: Placebo
    Administered IV

Recruiting Locations

Center For Dermatology Clinical Research, Inc.
Fremont, California 94538
Contact:
510-797-0140

Northridge Clinical Trials
Northridge, California 91325
Contact:
818-350-7482

Health Clinical Research, LLC
Cutler Bay, Florida 33189
Contact:
786-280-1977

Revival Research Institute, LLC
Troy, Michigan 48084
Contact:
248-590-0298

Stracskin
Portsmouth, New Hampshire 03801
Contact:
617-833-9995

Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
San Antonio, Texas 78235
Contact:
210-852-2779

Jordan Valley Dermatology & Research Center
South Jordan, Utah 84095

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.