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Recruiting NCT07533019

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

Phase II Interventional Vitiligo Non-Segmental Vitiligo (NSV)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LY4005130, Placebo.
Who it may be relevant to
Registry conditions: Vitiligo, Non-Segmental Vitiligo (NSV). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Belgium, Canada, China, Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug LY4005130
    Administered IV
  • Drug Placebo
    Administered IV

Primary outcome measures

  • Percentage of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI) 75 [Time frame: Week 24]
Secondary outcome measures (3)
  • Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 75 [Time frame: Week 24]
  • Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Skin Biopsy [Time frame: Baseline, Week 24]
  • Pharmacokinetics (PK): Observed Trough of LY4005130 Serum Concentration [Time frame: Week 24]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 18 centers
  • Medical Dermatology Specialists — Phoenix
  • Saguaro Dermatology - Phoenix — Phoenix
  • Center For Dermatology Clinical Research, Inc. — Fremont
  • Northridge Clinical Trials — Northridge
  • Cura Clinical Research - Oxnard — Oxnard
  • Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway — Santa Clarita
  • Health Clinical Research, LLC — Miami
  • K2 Medical Research - Tampa — Tampa
  • … and 10 more centers
Canada · 6 centers
  • INTERMED Groupe Sante — Chicoutimi
  • DermEffects — London
  • Dar Clinical Research - Ottawa - Hunt Club Road — Ottawa
  • The Centre for Dermatology — Richmond Hill
  • Research Toronto — Toronto
  • SIMa Recherche — Verdun
China · 4 centers
  • Peking University People's Hospital — Beijing
  • Hangzhou Third People's Hospital — Hangzhou
  • Shanghai Skin Disease Hospital — Shanghai
  • The University of Hong Kong-Shenzhen Hospital — Shenzhen
Poland · 4 centers
  • Centrum Badan Klinicznych PI-House sp. z o.o. — Gdansk
  • Diamond Clinic — Krakow
  • Dermedic Jacek Zdybski — Ostrowiec Świętokrzyski
  • Centrum Medyczne Ginemedica — Wroclaw
Belgium · 3 centers
  • Anima Diepenbeek — Diepenbeek
  • UZ Gent — Ghent
  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman — Liège

Identifiers

NCT: NCT07533019 · 27773 · J5D-MC-FPAD · 2025-524726-18-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗