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
Eli Lilly and Company
Summary
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.
Eligibility
- Age range
- 18–50 years
- Sex
- All
- 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…
Interventions
- DrugLY4005130
Administered IV
- DrugPlacebo
Administered IV
Locations (29)
- Center For Dermatology Clinical Research, Inc.Fremont, California
- Northridge Clinical TrialsNorthridge, California
- Cura Clinical Research - Santa Clarita - Kelly Johnson ParkwaySanta Clarita, California
- Health Clinical Research, LLCMiami, Florida
- Brigham and Women's HospitalBoston, Massachusetts
- Revival Research Institute, LLCTroy, Michigan