VitiligoPhase 2NCT07533019
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
A Phase 2 study testing LY4005130 in people with Vitiligo and Non-Segmental Vitiligo (NSV), run by Eli Lilly and Company at 35 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vitiligo, Non-Segmental Vitiligo (NSV)
- 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
- 66 participants
- Where
- 35 sitesin 5 countries
- Study dates
- 14 Apr 2026to Sep 2027
- Phase
- Phase 2
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
35 sites in 5 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
35 sites in 5 countries
United States18 sites, 18 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
617-732-4918
Arash Mostaghimi
- Recruiting
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538
510-797-0140
Sunil Dhawan
- Recruiting
Accurate Clinical Research, Inc
Humble, Texas, 77346
281-760-3930
Chinelo Fangtang
- Recruiting
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
317-516-5030
Scott Fretzin
- Recruiting
Health Clinical Research, LLC
Miami, Florida, 33189
786-280-1977
Soroush Aghigh
- Recruiting
Northridge Clinical Trials
Northridge, California, 91325
818-350-7482
Navid Ezra
- Recruiting
Cura Clinical Research - Oxnard
Oxnard, California, 93030
833-525-2872
Michael Lin
- Recruiting
Medical Dermatology Specialists
Phoenix, Arizona, 85006
602-354-5770
Lindsay Ackerman
- Recruiting
Saguaro Dermatology - Phoenix
Phoenix, Arizona, 85008
480-562-3610
Dathan Hamann
- Recruiting
Stracskin
Portsmouth, New Hampshire, 03801
617-833-9995
Abel Jarell
- Recruiting
Clinical Research Partners, LLC
Richmond, Virginia, 23226
804-477-3045
Robert Call
- Recruiting
Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
San Antonio, Texas, 78235
210-852-2779
John Browning
- Recruiting
Advanced Medical Research, PC.
Sandy Springs, Georgia, 30328
Jamie Weisman
- 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
K2 Medical Research - Tampa
Tampa, Florida, 33634
813-800-5252
Kelley Wilson
- Recruiting
Equity Medical
The Bronx, New York, 10455
332-223-6128
Maira Fonseca
- Recruiting
Revival Research Institute, LLC
Troy, Michigan, 48084
248-590-0298
Ali Moiin
Canada6 sites, 6 recruiting
- Recruiting
INTERMED Groupe Sante
Chicoutimi, G7H 7Y8
418-602-6620
Doria Grimard
- Recruiting
DermEffects
London, N6H 5L5
519-204-6868
Wei Jing Loo
- Recruiting
Dar Clinical Research - Ottawa - Hunt Club Road
Ottawa, K1V 1C1
Reetesh Bose
- Recruiting
The Centre for Dermatology
Richmond Hill, L4B 1A5
Mani Raman
- Recruiting
Research Toronto
Toronto, M4W 2N4
4169620123
Sameh Hanna
- Recruiting
SIMa Recherche
Verdun, H4G 2L8
5147308398
Simon Nigen
China4 sites, 4 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100034
Jianzhong Zhang
- Recruiting
Hangzhou Third People's Hospital
Hangzhou, 310009
Xiuzu Song
- Recruiting
Shanghai Skin Disease Hospital
Shanghai, 200071
Yuling Shi
- Not yet recruiting
The University of Hong Kong-Shenzhen Hospital
Shenzhen, 518053
13923848084
zhenying zhang
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
Belgium3 sites, 3 recruiting
- Recruiting
Anima Diepenbeek
Diepenbeek, 3590
+32 11 94 91 15
Hilde Bollen
- Recruiting
UZ Gent
Ghent, 9000
+3293322287
Reinhart Speeckaert
- Recruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000
+3243237232
ARJEN NIKKELS
About this study
Official title: 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.
- Conditions
- Vitiligo, Non-Segmental Vitiligo (NSV)
- Being tested
- LY4005130, Placebo
- Medical subject headings
- Vitiligo
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 Facial Vitiligo Area Scoring Index (F-VASI) 75
Measured: Week 24
Secondary outcomes (3)
Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 75
Measured: Week 24
Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Skin Biopsy
Measured: Baseline, Week 24
Pharmacokinetics (PK): Observed Trough of LY4005130 Serum Concentration
Measured: 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 completionMay 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies 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
- 66 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
- NCT07533019
- Sponsor's protocol ID
- 27773
- Other IDs
- J5D-MC-FPAD, 2025-524726-18-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2026
- Last updated
- 8 Oct 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.