ClinicalTrials.gg
RecruitingNCT07533006Updated Nov 4, 2026

A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)

A Phase 2 interventional study of LY4005130 and Placebo in Alopecia Areata, sponsored by Eli Lilly and Company. Recruiting at 30 sites in 7 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Updated Nov 4, 2026Site recruiting status changedEnrollment updated+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alopecia Areata

Browse trials for

03

In context

Alopecia Areata

220 studies on the registry are indexed under Alopecia Areata; 61 are open to participants now.

This study's planned enrollment of 65 is above the median of 50 across 171 interventional studies indexed under Alopecia Areata.

Browse Alopecia Areata studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 9, 2026. See what changed

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
65 participants (estimated)

Study arms

  • Experimental
    LY4005130

    LY4005130 administered intravenously (IV)

    Drug: LY4005130

  • Placebo comparator
    Placebo

    Placebo administered IV

    Drug: Placebo

Interventions

  • Administered IV

  • DrugPlacebo

    Administered IV

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20

    Time frame: Week 24

Secondary outcomes

  1. Pharmacokinetics (PK): Trough Concentrations of LY4005130

    Time frame: Baseline Through Week 20

  2. Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Scalp Biopsy

    Scalp Biopsy

    Time frame: Baseline, Week 24

07

Study locations

30 of 30 sites recruiting
  • Center For Dermatology Clinical Research, Inc.
    Fremont, California 94538, United States
    Recruiting
    • · Contact510-797-0140
    • Sunil Dhawan · Principal investigator
  • Northridge Clinical Trials
    Northridge, California 91325, United States
    Recruiting
    • · Contact818-350-7482
    • Navid Ezra · Principal investigator
  • Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway
    Santa Clarita, California 91355, United States
    Recruiting
    • · Contact833-525-2872
    • Bernard Raskin · Principal investigator
  • Health Clinical Research, LLC
    Cutler Bay, Florida 33189, United States
    Recruiting
    • · Contact786-280-1977
    • Soroush Aghigh · Principal investigator
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
    Recruiting
    • · Contact617-732-4918
    • Arash Mostaghimi · Principal investigator
  • Revival Research Institute, LLC
    Troy, Michigan 48084, United States
    Recruiting
    • · Contact248-590-0298
    • Ali Moiin · Principal investigator
  • Stracskin
    Portsmouth, New Hampshire 03801, United States
    Recruiting
    • · Contact617-833-9995
    • Abel Jarell · Principal investigator
  • Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
    San Antonio, Texas 78235, United States
    Recruiting
    • · Contact210-852-2779
    • John Browning · Principal investigator
  • Jordan Valley Dermatology & Research Center
    South Jordan, Utah 84095, United States
    Recruiting
    • Douglass Forsha · Principal investigator
  • Kelowna Health and Memory Centre
    Kelowna, V1Y 5A8, Canada
    Recruiting
    • Nicola Gray · Principal investigator
  • Ryan Clinical Research Inc.
    Newmarket, L3Y 5G8, Canada
    Recruiting
    • · Contact905-235-5232
    • Sanjay Siddha · Principal investigator
  • Dar Clinical Research - Ottawa - Hunt Club Road
    Ottawa, K1V 1C1, Canada
    Recruiting
    • Reetesh Bose · Principal investigator
  • SIMa Recherche
    Verdun, H4G 2L8, Canada
    Recruiting
    • · Contact5147308398
    • Simon Nigen · Principal investigator
  • Beijing Friendship Hospital Affiliate of Capital University
    Beijing, 100050, China
    Recruiting
    • Fenglin Zhuo · Principal investigator
  • Huashan Hospital, Fudan University
    Shanghai, 200040, China
    Recruiting
    • Wenyu Wu · Principal investigator
  • Shanghai Skin Disease Hospital
    Shanghai, 200071, China
    Recruiting
    • Yuling Shi · Principal investigator
  • Tianjin Medical University General Hospital
    Tianjin, 300052, China
    Recruiting
    • Huiping Wang · Principal investigator
  • Erasmus Medisch Centrum
    Rotterdam, 3015 GD, Netherlands
    Recruiting
    • · Contact0647074229
    • Rick Waalboer-Spuij · Principal investigator
  • Centrum Badan Klinicznych PI-House sp. z o.o.
    Gdansk, 80-546, Poland
    Recruiting
    • · Contact48513104911
    • Aleksandra Okuniewska · Principal investigator
  • Diamond Clinic
    Krakow, 31-559, Poland
    Recruiting
    • · Contact+ 48 696 049 029
    • Barbara Rewerska · Principal investigator
  • Dermedic Jacek Zdybski
    Ostrowiec Świętokrzyski, 27-400, Poland
    Recruiting
    • · Contact786643111
    • Jacek Zdybski · Principal investigator
  • Centrum Medyczne Ginemedica
    Wroclaw, 50-414, Poland
    Recruiting
    • Justyna Kwapisz · Principal investigator
  • Chung-Ang University Hospital
    Dongjak-gu, 06973, South Korea
    Recruiting
    • Beomjoon Kim · Principal investigator
  • Inha University Hospital
    Incheon, 22332, South Korea
    Recruiting
    • Gwang Seong Choi · Principal investigator
  • Jeonbuk National University Hospital
    Jeonju, 54907, South Korea
    Recruiting
    • Jin Park · Principal investigator
  • Seoul National University Hospital
    Seoul, 03080, South Korea
    Recruiting
    • OHSANG KWON · Principal investigator
  • Kyung Hee University Hospital at Gangdong
    Seoul, 05278, South Korea
    Recruiting
    • Bark Lynn Lew · Principal investigator
  • Royal London Hospital
    London, E1 1FR, United Kingdom
    Recruiting
    • Maria Angeliki Gkini · Principal investigator
  • Chelsea and Westminster Hospital NHS Foundation Trust
    London, SW10 9NH, United Kingdom
    Recruiting
    • Leila Asfour · Principal investigator
  • Salford Royal Hospital
    Salford, M6 8HD, United Kingdom
    Recruiting
    • Matthew Harries · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Jun 2027, 14 months after the start.

Of 30 phase 2 interventional studies under Alopecia Areata, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 35. This study's planned 14 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 9, 2026
First posted
Apr 16, 2026
StartActual
Apr 14, 2026
Primary completionEst.
Jun 2027
CompletionEst.
Oct 2027
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
5 sites changed recruiting status (5 now recruiting)
Show 5 sites
  • SIMa Recherche · Verdun, CanadaNot yet recruiting→Recruiting
  • Tianjin Medical University General Hospital · Tianjin, ChinaNot yet recruiting→Recruiting
  • Inha University Hospital · Incheon, South KoreaNot yet recruiting→Recruiting
  • Salford Royal Hospital · Salford, United KingdomNot yet recruiting→Recruiting
  • Chelsea and Westminster Hospital NHS Foundation Trust · London, United KingdomNot yet recruiting→Recruiting
across 2 updates, Oct 9, 2026 – Nov 4, 2026
Enrollment
60→65
Oct 28, 2026
Eligibility
Maximum age 50 Years→60 Years; 1 exclusion criterion removed
What changed in the criteria
Exclusion criteria
  • RemovedHave received oral JAK Inhibitors in the past
Oct 9, 2026
Secondary outcomes
1 removed
What changed in the outcomes
  • RemovedPercentage of Participants Achieving At Least 50 Percent (%) Improvement from Baseline (SALT50)Time frame: Week 24
Oct 9, 2026
Show all 3 updates
  1. Nov 4, 2026
    Chelsea and Westminster Hospital NHS Foundation Trust is now Recruiting
    + 1 other change: verification date
  2. Oct 28, 2026
    Enrollment 60→65
    + 2 other changes: contact details and site details
  3. Oct 9, 2026
    4 sites changed recruiting status (4 now recruiting)
    Show 4 sites
    • SIMa Recherche · Verdun, CanadaNot yet recruiting→Recruiting
    • Tianjin Medical University General Hospital · Tianjin, ChinaNot yet recruiting→Recruiting
    • Inha University Hospital · Incheon, South KoreaNot yet recruiting→Recruiting
    • Salford Royal Hospital · Salford, United KingdomNot yet recruiting→Recruiting
    Eligibility Maximum age 50 Years→60 Years; 1 exclusion criterion removed
    What changed in the criteria
    Exclusion criteria
    • RemovedHave received oral JAK Inhibitors in the past
    Secondary outcomes 1 removed
    What changed in the outcomes
    • RemovedPercentage of Participants Achieving At Least 50 Percent (%) Improvement from Baseline (SALT50)Time frame: Week 24
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07533006
Responsible party
Sponsor
First posted
Apr 16, 2026
Start date
Apr 14, 2026
Primary completion
Jun 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: LY4005130

Start the discussion