What this study is
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.
What's being tested
- LY4005130
Intervention · DRUG
- Placebo
Intervention · DRUG
Both interventions
Administered IV
Study details
- 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
- Sponsor
- Eli Lilly and Company
- Conditions
- Alopecia Areata
- Enrolling
- 65 people
- Starts
- 2026-04-14
- Est. completion
- 2027-10
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 60 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (30)
30 openCenter For Dermatology Clinical Research, Inc.
Fremont, California, United States
- Contact510-797-0140
- Sunil Dhawan · Principal investigator
RecruitingNorthridge Clinical Trials
Northridge, California, United States
- Contact818-350-7482
- Navid Ezra · Principal investigator
RecruitingCura Clinical Research - Santa Clarita - Kelly Johnson Parkway
Santa Clarita, California, United States
- Contact833-525-2872
- Bernard Raskin · Principal investigator
RecruitingHealth Clinical Research, LLC
Cutler Bay, Florida, United States
- Contact786-280-1977
- Soroush Aghigh · Principal investigator
RecruitingBrigham and Women's Hospital
Boston, Massachusetts, United States
- Contact617-732-4918
- Arash Mostaghimi · Principal investigator
RecruitingRevival Research Institute, LLC
Troy, Michigan, United States
- Contact248-590-0298
- Ali Moiin · Principal investigator
RecruitingStracskin
Portsmouth, New Hampshire, United States
- Contact617-833-9995
- Abel Jarell · Principal investigator
RecruitingTexas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
San Antonio, Texas, United States
- Contact210-852-2779
- John Browning · Principal investigator
RecruitingJordan Valley Dermatology & Research Center
South Jordan, Utah, United States
- Douglass Forsha · Principal investigator
Recruiting
21 sites outside the US
Kelowna Health and Memory Centre
Kelowna, Canada
- Nicola Gray · Principal investigator
RecruitingRyan Clinical Research Inc.
Newmarket, Canada
- Contact905-235-5232
- Sanjay Siddha · Principal investigator
RecruitingDar Clinical Research - Ottawa - Hunt Club Road
Ottawa, Canada
- Reetesh Bose · Principal investigator
Recruiting- Recruiting
Beijing Friendship Hospital Affiliate of Capital University
Beijing, China
- Fenglin Zhuo · Principal investigator
RecruitingHuashan Hospital, Fudan University
Shanghai, China
- Wenyu Wu · Principal investigator
RecruitingShanghai Skin Disease Hospital
Shanghai, China
- Yuling Shi · Principal investigator
RecruitingTianjin Medical University General Hospital
Tianjin, China
- Huiping Wang · Principal investigator
RecruitingErasmus Medisch Centrum
Rotterdam, Netherlands
- Contact0647074229
- Rick Waalboer-Spuij · Principal investigator
RecruitingCentrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Poland
- Contact48513104911
- Aleksandra Okuniewska · Principal investigator
Recruiting- Recruiting
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Poland
- Contact786643111
- Jacek Zdybski · Principal investigator
RecruitingCentrum Medyczne Ginemedica
Wroclaw, Poland
- Justyna Kwapisz · Principal investigator
RecruitingChung-Ang University Hospital
Dongjak-gu, South Korea
- Beomjoon Kim · Principal investigator
RecruitingInha University Hospital
Incheon, South Korea
- Gwang Seong Choi · Principal investigator
RecruitingJeonbuk National University Hospital
Jeonju, South Korea
- Jin Park · Principal investigator
RecruitingSeoul National University Hospital
Seoul, South Korea
- OHSANG KWON · Principal investigator
RecruitingKyung Hee University Hospital at Gangdong
Seoul, South Korea
- Bark Lynn Lew · Principal investigator
RecruitingRoyal London Hospital
London, United Kingdom
- Maria Angeliki Gkini · Principal investigator
RecruitingChelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom
- Leila Asfour · Principal investigator
RecruitingSalford Royal Hospital
Salford, United Kingdom
- Matthew Harries · Principal investigator
Recruiting
Study team
Sponsor
Eli Lilly and Company
Study ID 27772
Study director
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
CONTACT
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.