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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Vitiligo; Non-Segmental Vitiligo (NSV)

Treatments: Drug: Placebo; Drug: LY4005130

Study type: Interventional

Funder types: Industry

Identifiers

NCT07533019

27773

2025-524726-18-00 (Other Identifier)

J5D-MC-FPAD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

LY4005130

Experimental group

Description:

LY4005130 administered intravenously (IV)

Treatment:

Drug: LY4005130

Placebo

Placebo Comparator group

Description:

Placebo administered IV

Treatment:

Drug: Placebo