A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo

May 20, 2026 updated by: Eli Lilly and Company

A Phase 2, Randomized, 24-Week, Multicenter, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants With Non-Segmental Vitiligo

The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in participants with non-segmental vitiligo (NSV) when compared with placebo. The study drug will be administered intravenously (IV) (into a vein in the arm).

Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

The study will last approximately 48 weeks, including screening.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Belgium
      • Alken, Belgium, 3570
        • Not yet recruiting
        • ANIMA Research
        • Principal Investigator:
          • Hilde Bollen
        • Contact:
          • Phone Number: +32 11 94 91 15
      • Ghent, Belgium, 9000
        • Not yet recruiting
        • UZ Gent
        • Contact:
          • Phone Number: +3293322287
        • Principal Investigator:
          • Reinhart Speeckaert
      • Liège, Belgium, 4000
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
        • Contact:
          • Phone Number: +3243237232
        • Principal Investigator:
          • ARJEN NIKKELS
  • Canada
      • Chicoutimi, Canada, G7H 7Y8
        • Not yet recruiting
        • INTERMED groupe santé
        • Principal Investigator:
          • Doria Grimard
        • Contact:
          • Phone Number: 418-602-6620
      • London, Canada, N6H 5L5
        • Not yet recruiting
        • DermEffects
        • Principal Investigator:
          • Wei Jing Loo
        • Contact:
          • Phone Number: 519-204-6868
      • Ottawa, Canada, K1V 1C1
        • Not yet recruiting
        • Dar Clinical Research - Ottawa - Hunt Club Road
        • Principal Investigator:
          • Reetesh Bose
      • Richmond Hill, Canada, L4B 1A5
        • Not yet recruiting
        • The Centre For Dermatology
        • Principal Investigator:
          • Mani Raman
      • Toronto, Canada, M4W 2N4
        • Not yet recruiting
        • Research Toronto
        • Principal Investigator:
          • Sameh Hanna
        • Contact:
          • Phone Number: 4169620123
      • Verdun, Canada, H4G 2L8
        • Not yet recruiting
        • Sima Recherche
        • Contact:
          • Phone Number: 5147308398
        • Principal Investigator:
          • Simon Nigen
  • China
      • Beijing, China, 100034
        • Not yet recruiting
        • Peking University People's Hospital
        • Principal Investigator:
          • Jianzhong Zhang
      • Hangzhou, China, 310009
        • Not yet recruiting
        • Hangzhou Third People's Hospital
        • Principal Investigator:
          • Xiuzu Song
      • Shanghai, China, 200071
        • Not yet recruiting
        • Shanghai Skin Disease Hospital
        • Principal Investigator:
          • Yuling Shi
      • Shenzhen, China, 518053
        • Not yet recruiting
        • The University of Hong Kong-Shenzhen Hospital
        • Principal Investigator:
          • zhenying zhang
        • Contact:
          • Phone Number: 13923848084
  • Poland
      • Gdansk, Poland, 80-546
        • Not yet recruiting
        • Centrum Badan Klinicznych PI-House sp. z o.o.
        • Contact:
          • Phone Number: 48513104911
        • Principal Investigator:
          • Aleksandra Okuniewska
      • Krakow, Poland, 31-559
        • Not yet recruiting
        • Diamond Clinic
        • Principal Investigator:
          • Barbara Rewerska
        • Contact:
          • Phone Number: + 48 696 049 029
      • Ostrowiec Świętokrzyski, Poland, 27-400
        • Not yet recruiting
        • Dermedic Jacek Zdybski
        • Principal Investigator:
          • Jacek Zdybski
        • Contact:
          • Phone Number: 786643111
      • Wroclaw, Poland, 50-414
        • Not yet recruiting
        • Centrum Medyczne Ginemedica
        • Principal Investigator:
          • Justyna Kwapisz
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Medical Dermatology Specialists
        • Principal Investigator:
          • Lindsay Ackerman
        • Contact:
          • Phone Number: 602-354-5770
      • Phoenix, Arizona, United States, 85008
        • Not yet recruiting
        • Saguaro Dermatology - Phoenix
        • Principal Investigator:
          • Dathan Hamann
        • Contact:
          • Phone Number: 480-562-3610
    • California
      • Fremont, California, United States, 94538
        • Recruiting
        • Center For Dermatology Clinical Research, Inc.
        • Principal Investigator:
          • Sunil Dhawan
        • Contact:
          • Phone Number: 510-797-0140
      • Northridge, California, United States, 91325
        • Recruiting
        • Northridge Clinical Trials
        • Principal Investigator:
          • Navid Ezra
        • Contact:
          • Phone Number: 818-350-7482
      • Oxnard, California, United States, 93030
        • Not yet recruiting
        • Cura Clinical Research - Oxnard
        • Principal Investigator:
          • Michael Lin
        • Contact:
          • Phone Number: 833-525-2872
      • Santa Clarita, California, United States, 91355
        • Not yet recruiting
        • Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway
        • Contact:
          • Phone Number: 833-525-2872
        • Principal Investigator:
          • Bernard Raskin
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Health Clinical Research, LLC
        • Principal Investigator:
          • Soroush Aghigh
        • Contact:
          • Phone Number: 786-280-1977
      • Tampa, Florida, United States, 33634
        • Recruiting
        • K2 Medical Research - Tampa
        • Contact:
          • Phone Number: 813-800-5252
        • Principal Investigator:
          • Kelley Wilson
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Not yet recruiting
        • Advanced Medical Research, PC.
        • Principal Investigator:
          • Jamie Weisman
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Not yet recruiting
        • Dawes Fretzin Clinical Research Group, LLC
        • Contact:
          • Phone Number: 317-516-5030
        • Principal Investigator:
          • Scott Fretzin
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Arash Mostaghimi
        • Contact:
          • Phone Number: 617-732-4918
    • Michigan
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Revival Research Institute, LLC
        • Principal Investigator:
          • Ali Moiin
        • Contact:
          • Phone Number: 248-590-0298
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Recruiting
        • Stracskin
        • Principal Investigator:
          • Abel Jarell
        • Contact:
          • Phone Number: 617-833-9995
    • New York
      • The Bronx, New York, United States, 10455
        • Recruiting
        • Equity Medical
        • Principal Investigator:
          • Maira Fonseca
    • Texas
      • Humble, Texas, United States, 77346
        • Recruiting
        • Accurate Clinical Research, Inc
        • Contact:
          • Phone Number: 281-760-3930
        • Principal Investigator:
          • Chinelo Fangtang
      • San Antonio, Texas, United States, 78235
        • Recruiting
        • Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
        • Contact:
          • Phone Number: 210-852-2779
        • Principal Investigator:
          • John Browning
    • Utah
      • South Jordan, Utah, United States, 84095
        • Recruiting
        • Jordan Valley Dermatology & Research Center
        • Principal Investigator:
          • Douglass Forsha
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Clinical Research Partners, LLC
        • Contact:
          • Phone Number: 804-477-3045
        • Principal Investigator:
          • Robert Call

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eligible participants must have the following at both screening and baseline:

    • A clinical diagnosis of non-segmented vitiligo (NSV) for at least 3 months
    • Body surface area (BSA) involvement of 4% to 60%, inclusive, excluding involvement at palms of the hands, soles of the feet, or dorsal aspect of the feet
    • BSA involvement of ≥0.5% on the face
    • F-VASI ≥0.5 and T-VASI ≥3, and
    • Either active or stable disease at both screening and baseline

Exclusion Criteria:

  • Participants who have other types of vitiligo that are not considered active or stable vitiligo
  • Currently have active forms of other disorders of pigmentation
  • Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions that would interfere with evaluation of vitiligo or response to treatment
  • Have a superficial skin infection within 2 weeks before baseline. Participants may be rescreened after the infection is resolved
  • Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year prior to screening
  • Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking the study intervention or interfere with the interpretation of data
  • Any previous JAK inhibitor therapy, systemic or topical (for example, ruxolitinib, tofacitinib, baricitinib, upadacitinib, filgotinib, lestaurtinib, pacritinib) will NOT be allowed. Participant MUST be JAK inhibitor therapy-naïve

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered IV
Drug: Placebo
Administered IV
Experimental: LY4005130
LY4005130 administered intravenously (IV)
Drug: LY4005130
Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI) 75
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 75
Time Frame: Week 24
Week 24
Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Skin Biopsy
Time Frame: Baseline, Week 24
Baseline, Week 24
Pharmacokinetics (PK): Observed Trough of LY4005130 Serum Concentration
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27773
  • J5D-MC-FPAD (Other Identifier: Eli Lilly and Company)
  • 2025-524726-18-00 (Other Identifier: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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