A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LY4005130, Placebo.
- Who it may be relevant to
- Registry conditions: Alopecia Areata. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, China, Netherlands, Poland +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug LY4005130
Administered IV - Drug Placebo
Administered IV
Primary outcome measures
- Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20 [Time frame: Week 24]
Secondary outcome measures (3)
- Percentage of Participants Achieving At Least 50 Percent (%) Improvement from Baseline (SALT50) [Time frame: Week 24]
- Pharmacokinetics (PK): Trough Concentrations of LY4005130 [Time frame: Baseline Through Week 20]
- Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Scalp Biopsy [Time frame: Baseline, Week 24]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Center For Dermatology Clinical Research, Inc. — Fremont
- Northridge Clinical Trials — Northridge
- Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway — Santa Clarita
- Health Clinical Research, LLC — Cutler Bay
- Brigham and Women's Hospital — Boston
- Revival Research Institute, LLC — Troy
- Stracskin — Portsmouth
- Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue — San Antonio
- … and 1 more center
South Korea · 5 centers
- Chung-Ang University Hospital — Dongjak-gu
- Inha University Hospital — Incheon
- Jeonbuk National University Hospital — Jeonju
- Seoul National University Hospital — Seoul
- Kyung Hee University Hospital at Gangdong — Seoul
Canada · 4 centers
- Kelowna Health and Memory Centre — Kelowna
- Ryan Clinical Research Inc. — Newmarket
- Dar Clinical Research - Ottawa - Hunt Club Road — Ottawa
- SIMa Recherche — Verdun
China · 4 centers
- Beijing Friendship Hospital Affiliate of Capital University — Beijing
- Huashan Hospital, Fudan University — Shanghai
- Shanghai Skin Disease Hospital — Shanghai
- Tianjin Medical University General Hospital — Tianjin
Poland · 4 centers
- Centrum Badan Klinicznych PI-House sp. z o.o. — Gdansk
- Diamond Clinic — Krakow
- Dermedic Jacek Zdybski — Ostrowiec Świętokrzyski
- Centrum Medyczne Ginemedica — Wroclaw
United Kingdom · 3 centers
- Royal London Hospital — London
- Chelsea and Westminster Hospital NHS Foundation Trust — London
- Salford Royal Hospital — Salford
Netherlands · 1 center
- Erasmus Medisch Centrum — Rotterdam
Identifiers
NCT: NCT07533006 · 27772 · J5D-MC-FPAC · 2025-524727-41-00