Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
65
Countries
2
Sites
5
Alopecia Areata
To compare the efficacy of LY4005130 versus placebo in the treatment of participants with severe AA
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2026-06-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-524727-41-00
- WHO UTN
- U1111-1334-3172
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Pharmacodynamic, Pharmacokinetic
To compare the efficacy of LY4005130 versus placebo in the treatment of participants with severe AA
Conditions and MedDRA coding
Alopecia Areata
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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 6
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD13488056 · Product
- Active substance
- LY4005130
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Y-Prime, Inc. ORL-000017834
|
Pennsylvania, United States | Data management |
| Canfield Scientific Inc. ORG-100042834
|
Parsippany, United States | Other |
| WCG Clinical Inc. ORG-100040730
|
Indianapolis, United States | Other |
| Trialbee AB ORG-100051369
|
Malmo, Sweden | Code 2 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| Labcorp ORL-000017833
|
Meyrin, Switzerland | Laboratory analysis |
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 5 | 1 |
| Poland | Authorised, recruitment pending | 9 | 4 |
| Rest of world
Korea, Republic of, United Kingdom, United States, Canada, China
|
— | 51 | — |
Investigational sites
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Dermatology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Centrum Badan Klinicznych Pi-House Sp. z o.o.
NA, Ul. Na Zaspe 3, 80-546, Gdansk
Ginemedica Research Sp. z o.o.
NA, Ul. Podwale 83/21, 50-414, Wroclaw
Diamond Clinic Sp. z o.o.
NA, Ul. Stefana Rogozinskiego 6/U3, 31-559, Cracow
Zdybski Med Sp. z o.o.
NA, Ul. Henryka Sienkiewicza 65/14, 27-400, Ostrowiec Swietokrzyski
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 54 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-524-727-41-00_redacted | Initial |
| Protocol (for publication) | D4_Patient Facing Documents_Copyright Template | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_TC | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC__Poster_Master_Persona 3_PL_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Brochure_DG_Master_PL_Print_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Brochure_DG_Master_PL_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Brochure_Master_PL_Print_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Brochure_Master_PL_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_CT_Living With Alopecia Areata_DG_Master_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_CT_Living With Alopecia Areata_DG_Master_PL_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_CT_Living With Alopecia Areata_Master_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_CT_Living With Alopecia Areata_Master_PL_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_CT_Skin Biopsy Infographic_DG_Master_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_CT_Skin Biopsy Infographic_DG_Master_PL_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_CT_Skin Biopsy Infographic_Master_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_CT_Skin Biopsy Infographic_Master_PL_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_CT_Video_Biopsy-Basics_LML_Storyboard_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_LT trialPage_DG_Master_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster Master Persona 1_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster Master Persona 1_PL_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_DG_Master_Persona 3_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_DG_Master_Persona 3_PL_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_DG_Master_Persona 4_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_DG_Master_Persona 4_PL_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_DG_Master_Persona1_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_DG_Master_Persona1_PL_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_DG_Master_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_DG_Master_PL_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_Master_Persona 3_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_Master_Persona 4_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_Master_Persona 4_PL_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_Master_Persona2_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_Master_Persona2_PL_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_Master_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster_Master_PL_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster-DG_Master_Persona2_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Poster-DG_Master_Persona2_PL_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Trialbee_Digital_Marketing_Content_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Trialbee_Global_Privacy_Policy_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Trialbee_OverviewSupplementaryInformation_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Trialbee_Secondary_Assessment_PL_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FPAC_Trialbee_Self_Assessment_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_NL_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_FPAC_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice_Netherlands | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Compensation Information Sheet_Redacted | 1 |
| Subject information and informed consent form (for publication) | L3_Info Re insurance Conditions for Patient_PL | 1.0 |
| Subject information and informed consent form (for publication) | L4_Informed consent and patient recruitment procedure_PL | 1.0 |
| Subject information and informed consent form (for publication) | L4_Informed consent and patient recruitment procedure_PL_PL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524727-41-00_ENG_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524727-41-00_NL_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524727-41-00_PL _Redacted | 1.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-18 | Netherlands | Acceptable 2026-06-08
|
2026-06-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-07-07 | Acceptable 2026-06-08
|
2026-07-07 |