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NCT Number: NCT07533019

A Study 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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anima Diepenbeek, Diepenbeek, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4005130

Drug

Administered IV

Placebo

Drug

Administered IV

Primary outcomes

  1. Percentage of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI) 75

    Time frame: Week 24

Secondary outcomes

  1. Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 75

    Time frame: Week 24

  2. Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Skin Biopsy

    Time frame: Baseline, Week 24

  3. Pharmacokinetics (PK): Observed Trough of LY4005130 Serum Concentration

    Time frame: Week 24

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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