A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
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
3 other identifiers
interventional
60
5 countries
35
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2026
Shorter than P25 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2026
CompletedStudy Start
First participant enrolled
April 14, 2026
CompletedFirst Posted
Study publicly available on registry
April 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 10, 2027
April 16, 2026
April 1, 2026
1.1 years
April 9, 2026
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI) 75
Week 24
Secondary Outcomes (3)
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 75
Week 24
Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Skin Biopsy
Baseline, Week 24
Pharmacokinetics (PK): Observed Trough of LY4005130 Serum Concentration
Week 24
Study Arms (2)
LY4005130
EXPERIMENTALLY4005130 administered intravenously (IV)
Placebo
PLACEBO COMPARATORPlacebo administered IV
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Medical Dermatology Specialists
Phoenix, Arizona, 85006, United States
Saguaro Dermatology - Phoenix
Phoenix, Arizona, 85008, United States
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Northridge Clinical Trials
Northridge, California, 91325, United States
Cura Clinical Research - Oxnard
Oxnard, California, 93030, United States
Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway
Santa Clarita, California, 91355, United States
Health Clinical Research, LLC
Miami, Florida, 33176, United States
K2 Medical Research - Tampa
Tampa, Florida, 33634, United States
Advanced Medical Research, PC.
Sandy Springs, Georgia, 30328, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Revival Research Institute, LLC
Troy, Michigan, 48084, United States
Stracskin
Portsmouth, New Hampshire, 03801, United States
Equity Medical
The Bronx, New York, 10455, United States
Accurate Clinical Research, Inc
Humble, Texas, 77346, United States
Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
San Antonio, Texas, 78235, United States
Jordan Valley Dermatology & Research Center
South Jordan, Utah, 84095, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23226, United States
ANIMA Research
Alken, 3570, Belgium
UZ Gent
Ghent, 9000, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
INTERMED Groupe Sante
Chicoutimi, G7H 7Y8, Canada
DermEffects
London, N6H 5L5, Canada
Dar Clinical Research - Ottawa - Hunt Club Road
Ottawa, K1V 1C1, Canada
The Centre for Dermatology
Richmond Hill, L4B 1A5, Canada
Research Toronto
Toronto, M4W 2N4, Canada
SIMa Recherche
Verdun, H4G 2L8, Canada
Peking University People's Hospital
Beijing, 100034, China
Hangzhou Third People's Hospital
Hangzhou, 310009, China
Shanghai Skin Disease Hospital
Shanghai, 200071, China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, 518053, China
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546, Poland
Diamond Clinic
Krakow, 31-559, Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, 27-400, Poland
Centrum Medyczne Ginemedica
Wroclaw, 50-414, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2026
First Posted
April 16, 2026
Study Start
April 14, 2026
Primary Completion (Estimated)
May 21, 2027
Study Completion (Estimated)
September 10, 2027
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
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.