Alopecia AreataPhase 2NCT07533006
A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)
A Phase 2 study testing LY4005130 in people with Alopecia Areata, run by Eli Lilly and Company at 30 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- LY4005130
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 30 sitesin 7 countries
- Study dates
- 14 Apr 2026to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
30 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
30 sites in 7 countries
United States9 sites, 9 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
617-732-4918
Arash Mostaghimi
- Recruiting
Health Clinical Research, LLC
Cutler Bay, Florida, 33189
786-280-1977
Soroush Aghigh
- Recruiting
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538
510-797-0140
Sunil Dhawan
- Recruiting
Northridge Clinical Trials
Northridge, California, 91325
818-350-7482
Navid Ezra
- Recruiting
Stracskin
Portsmouth, New Hampshire, 03801
617-833-9995
Abel Jarell
- Recruiting
Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
San Antonio, Texas, 78235
210-852-2779
John Browning
- Recruiting
Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway
Santa Clarita, California, 91355
833-525-2872
Bernard Raskin
- Recruiting
Jordan Valley Dermatology & Research Center
South Jordan, Utah, 84095
Douglass Forsha
- Recruiting
Revival Research Institute, LLC
Troy, Michigan, 48084
248-590-0298
Ali Moiin
South Korea5 sites, 5 recruiting
- Recruiting
Chung-Ang University Hospital
Dongjak-gu, 06973
Beomjoon Kim
- Recruiting
Inha University Hospital
Incheon, 22332
Gwang Seong Choi
- Recruiting
Jeonbuk National University Hospital
Jeonju, 54907
Jin Park
- Recruiting
Seoul National University Hospital
Seoul, 03080
OHSANG KWON
- Recruiting
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Bark Lynn Lew
Canada4 sites, 4 recruiting
- Recruiting
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8
Nicola Gray
- Recruiting
Ryan Clinical Research Inc.
Newmarket, L3Y 5G8
905-235-5232
Sanjay Siddha
- Recruiting
Dar Clinical Research - Ottawa - Hunt Club Road
Ottawa, K1V 1C1
Reetesh Bose
- Recruiting
SIMa Recherche
Verdun, H4G 2L8
5147308398
Simon Nigen
China4 sites, 4 recruiting
- Recruiting
Beijing Friendship Hospital Affiliate of Capital University
Beijing, 100050
Fenglin Zhuo
- Recruiting
Huashan Hospital, Fudan University
Shanghai, 200040
Wenyu Wu
- Recruiting
Shanghai Skin Disease Hospital
Shanghai, 200071
Yuling Shi
- Recruiting
Tianjin Medical University General Hospital
Tianjin, 300052
Huiping Wang
Poland4 sites, 4 recruiting
- Recruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
48513104911
Aleksandra Okuniewska
- Recruiting
Diamond Clinic
Krakow, 31-559
+ 48 696 049 029
Barbara Rewerska
- Recruiting
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, 27-400
786643111
Jacek Zdybski
- Recruiting
Centrum Medyczne Ginemedica
Wroclaw, 50-414
Justyna Kwapisz
United Kingdom3 sites, 3 recruiting
- Recruiting
Royal London Hospital
London, E1 1FR
Maria Angeliki Gkini
- Recruiting
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH
Leila Asfour
- Recruiting
Salford Royal Hospital
Salford, M6 8HD
Matthew Harries
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medisch Centrum
Rotterdam, 3015 GD
0647074229
Rick Waalboer-Spuij
About this study
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
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.
- Conditions
- Alopecia Areata
- Being tested
- LY4005130, Placebo
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4005130Drug
Administered IV
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY4005130 | Experimental | LY4005130 administered intravenously (IV) Receives: Drug: LY4005130 |
| Placebo | Placebo comparator | Placebo administered IV Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20
Measured: Week 24
Secondary outcomes (2)
Pharmacokinetics (PK): Trough Concentrations of LY4005130
Measured: Baseline Through Week 20
Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Scalp Biopsy
Scalp Biopsy
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start14 Apr 2026
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533006
- Sponsor's protocol ID
- 27772
- Other IDs
- J5D-MC-FPAC, 2025-524727-41-00, 2025
- Status last verified
- Nov 2026
- First submitted
- 9 Apr 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07533006
- Acronym / sponsor ID
- 27772
- Conditions
- Alopecia Areata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY4005130 | Experimental | Drug: LY4005130LY4005130 administered intravenously (IV) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered IV |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have severe Alopecia Areata (AA) that meets all of the following criteria:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY4005130Administered IV | Drug | LY4005130 |
| PlaceboAdministered IV | Drug | Placebo |
Primary outcome
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20
Time frame: Week 24
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: 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.
Related trials for Alopecia Areata
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
30 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY4005130 in people with Alopecia Areata, run by Eli Lilly and Company at 30 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, South Korea, Canada, China, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.