Alopecia Areata
Conditions
Brief 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.
Interventions
DRUGLY4005130
Administered IV
DRUGPlacebo
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20 | Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving At Least 50 Percent (%) Improvement from Baseline (SALT50) | Week 24 | — |
| Pharmacokinetics (PK): Trough Concentrations of LY4005130 | Baseline Through Week 20 | — |
| Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Scalp Biopsy | Baseline, Week 24 | Scalp Biopsy |
Countries
Canada, China, Netherlands, Poland, South Korea, United Kingdom, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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
Outcome results
None listed