LY4005130 for adults 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

Phase 2 Interventional Eli Lilly and Company · NCT07533019

This study will test whether intravenous LY4005130 is safe and what side effects it may cause in adults with non-segmental vitiligo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsruxolitinib, tofacitinib, baricitinib, upadacitinib, filgotinib, lestaurtinib, pacritinib
Locations35 sites (Phoenix, Arizona and 34 other locations)
Trial IDNCT07533019 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial gives adult participants with non-segmental vitiligo intravenous LY4005130 or placebo and follows them for tolerability and adverse events. Blood tests will be used to track how the body processes the drug and any biological effects. Eligible participants must have had vitiligo for at least 3 months, 4–60% body surface involvement (with ≥0.5% on the face) and minimum F‑VASI and T‑VASI scores, and may have active or stable disease. The total participation period is about 48 weeks including screening, with visits at dermatology research centers in Arizona and California.

Who should consider this trial

Good fit: Adults with non-segmental vitiligo for at least 3 months who have 4%–60% body surface involvement (≥0.5% on the face) and meet minimum F‑VASI and T‑VASI thresholds are ideal candidates.

Not a fit: People with segmental vitiligo, other active pigment disorders or inflammatory skin conditions that interfere with evaluation, recent superficial skin infections, or who fall outside the BSA/VASI eligibility ranges are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, LY4005130 could provide a new systemic option to reduce depigmentation and improve repigmentation in adults with non-segmental vitiligo.

How similar studies have performed: Other systemic and biologic approaches for vitiligo have shown promise in some trials, but LY4005130's safety and effectiveness in non-segmental vitiligo have not yet been established.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Phoenix, Arizona and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions VitiligoNon-Segmental Vitiligo
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.