LY4005130 for adults with severe alopecia areata, compared with placebo
Tests LY4005130 against placebo in adults with severe alopecia areata.
Key facts
- Who runs it
- Eli Lilly and Company
- Where
- Boston, Cutler Bay, Fremont, Northridge, Portsmouth, San Antonio, Santa Clarita, South Jordan, and Troy, United StatesSee the 9 sitesAlso in 6 other countries, 21 sites
- Trial code
- NCT07533006
- EU 2025-524727-41-00
- U1111-1334-3172
- Registry title
- A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 65 people, planned
- Started
- 14 Apr 2026
- Expected to end
- Oct 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- LY4005130
- Placebo
- Record updated
- 4 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with severe alopecia areata, a condition where hair falls out in patches. It compares LY4005130, given into a vein, with a placebo.
- Age
- 18 Years to 60 Years
- Sex
- All sexes can join.
- Disease stage
- Severe alopecia areata with hair loss on ≥50% and ≤90% of the scalp (SALT score). The current episode has lasted at least 6 months and no more than 4 years. No significant hair regrowth on its own for at least 6 months.
- Earlier treatment
- People must agree not to use any alopecia areata treatments during the study.
Main reasons for not taking part
- Mainly the "diffuse" type of alopecia areata, with hair shedding all over the scalp
- Other forms of hair loss at present
- Unstable other disease needing frequent hospital stays or frequent drugs that weaken the immune system
- Major surgery within 8 weeks before screening, or major surgery needed during the study
- Past or present heart, lung, liver, gut, hormone, blood, nerve or mental health disorders, or other serious or unstable illness
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Primarily "diffuse" type of AA (characterized by diffuse hair shedding)
- Are currently experiencing other forms of alopecia
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Where in United States
Also in 6 other countries, 21 sites
- Brigham and Women's HospitalBoston, United StatesContact: Arash Mostaghimi (principal investigator)Taking people
- Health Clinical Research, LLCCutler Bay, United StatesContact: Soroush Aghigh (principal investigator)Taking people
- Center For Dermatology Clinical Research, Inc.Fremont, United StatesContact: Sunil Dhawan (principal investigator)Taking people
- Northridge Clinical TrialsNorthridge, United StatesContact: Navid Ezra (principal investigator)Taking people
- StracskinPortsmouth, United StatesContact: Abel Jarell (principal investigator)Taking people
- Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels AvenueSan Antonio, United StatesContact: John Browning (principal investigator)Taking people
- Cura Clinical Research - Santa Clarita - Kelly Johnson ParkwaySanta Clarita, United StatesContact: Bernard Raskin (principal investigator)Taking people
- Jordan Valley Dermatology & Research CenterSouth Jordan, United StatesContact: Douglass Forsha (principal investigator)Taking people
- Revival Research Institute, LLCTroy, United StatesContact: Ali Moiin (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
The study drug will be administered intravenously (IV) (into a vein in the arm).
The study will last approximately 48 weeks, including screening.
The 2 groups in the trial
- LY4005130Treatment being tested
LY4005130 administered intravenously (IV)
- PlaceboPlacebo, for comparison
Placebo administered IV
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- LY4005130 for adults with severe alopecia areata, compared with placeboGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07533006, who can take part
- Record updated
- 4 November 2026