Phase 2a Randomized, Double‑Blind, Placebo‑Controlled Study of LY4005130 in Adults with Non‑Segmental Vitiligo

The primary objective is to evaluate the efficacy of LY4005130 compared with placebo in adult participants with Non‑Segmental Vitiligo, assessing the drug’s ability to induce repigmentation and reduce disease activity, which is critical for establishing therapeutic benefit in this chronic depigmenting disorder.

The trial enrolled 52 participants diagnosed with non-segmental vitiligo (NSV). Both female and male patients were included, representing the patient group defined in the protocol. Eligible individuals were required to have a clinical diagnosis of NSV for at least three months, with body surface area involvement between 4 % and 60 % (excluding palms, soles, and dorsal feet) and at least 0.5 % facial involvement. Additional baseline criteria included specific F‑VASI and T‑VASI thresholds and either active or stable disease status. Age categories were defined by the study’s code numbers 3 and 4. No specific dietary, physical‑activity, or habit restrictions were reported as part of the enrollment criteria. Participants were selected based on meeting these inclusion parameters and were excluded if they failed to satisfy any of the required clinical or demographic conditions.

The study is a Phase 2a, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of LY4005130 in adult participants with Non-Segmental Vitiligo. Eligible individuals undergo a screening visit to confirm diagnosis, body‑surface‑area involvement, and disease activity; participants who meet all inclusion criteria proceed to a baseline visit where they are allocated 1:1 to receive either LY4005130 intravenously or placebo. Follow‑up assessments occur at four‑week intervals over a 24‑week treatment period, culminating in an end‑of‑study visit at week 24; the primary efficacy endpoint is the proportion achieving F-VASI 75. Total participant involvement is approximately 26 weeks, including screening, and may be terminated early for serious adverse events, protocol non‑compliance, withdrawal of consent, or unacceptable safety signals identified in interim analyses.

The investigational product LY4005130 is supplied as a solution for injection for intravenous administration. Each dose contains 0 mg of the active substance and is administered according to the study‑defined infusion schedule, which is identical for all participants receiving the test product.

The comparator is a matching placebo (product code SUB12581MIG) that contains no active pharmaceutical ingredient. The placebo is presented in the same container and appearance as the active product to maintain blinding, and it is administered by the same route and schedule as the investigational product.

Both study treatments are given at predetermined intervals over the 24‑week double‑blind period. Dosing visits are recorded in the electronic case report form, and infusion logs are reviewed by study staff to verify compliance with the administration schedule. Participants are monitored for infusion‑related reactions during and after each administration, and any deviations from the protocol‑specified dosing regimen are documented and reported according to regulatory requirements.

The primary efficacy parameter is the percentage of participants achieving Facial Vitiligo Area Scoring Index (F‑VASI) 75. This endpoint reflects the proportion of subjects who attain a 75 % reduction from baseline in facial vitiligo involvement as measured by the validated F‑VASI instrument.

Efficacy assessments will be conducted by trained investigators using the standardized F‑VASI scoring system at predefined study visits throughout the 24‑week treatment period. Collected data will be analyzed to determine the proportion of participants meeting the F‑VASI 75 criterion for each treatment arm.