RecruitingPhase 2NCT07533019

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


Sponsor

Eli Lilly and Company

Enrollment

60 participants

Start Date

Apr 14, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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

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Interventions

DRUGLY4005130

Administered IV

DRUGPlacebo

Administered IV


Locations(35)

Medical Dermatology Specialists

Phoenix, Arizona, United States

Saguaro Dermatology - Phoenix

Phoenix, Arizona, United States

Center For Dermatology Clinical Research, Inc.

Fremont, California, United States

Northridge Clinical Trials

Northridge, California, United States

Cura Clinical Research - Oxnard

Oxnard, California, United States

Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway

Santa Clarita, California, United States

Health Clinical Research, LLC

Miami, Florida, United States

K2 Medical Research - Tampa

Tampa, Florida, United States

Advanced Medical Research, PC.

Sandy Springs, Georgia, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Revival Research Institute, LLC

Troy, Michigan, United States

Stracskin

Portsmouth, New Hampshire, United States

Equity Medical

The Bronx, New York, United States

Accurate Clinical Research, Inc

Humble, Texas, United States

Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue

San Antonio, Texas, United States

Jordan Valley Dermatology & Research Center

South Jordan, Utah, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

ANIMA Research

Alken, Belgium

UZ Gent

Ghent, Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, Belgium

INTERMED Groupe Sante

Chicoutimi, Canada

DermEffects

London, Canada

Dar Clinical Research - Ottawa - Hunt Club Road

Ottawa, Canada

The Centre for Dermatology

Richmond Hill, Canada

Research Toronto

Toronto, Canada

SIMa Recherche

Verdun, Canada

Peking University People's Hospital

Beijing, China

Hangzhou Third People's Hospital

Hangzhou, China

Shanghai Skin Disease Hospital

Shanghai, China

The University of Hong Kong-Shenzhen Hospital

Shenzhen, China

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Poland

Diamond Clinic

Krakow, Poland

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, Poland

Centrum Medyczne Ginemedica

Wroclaw, Poland

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NCT07533019


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