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Efficacy and Safety of LY4005130 Compared with Placebo in Adults with Non‑Segmental Vitiligo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Non-Segmental Vitiligo is a skin disorder in which patches of skin lose pigment, creating white spots that can appear on the face and other areas. The study evaluates an intravenous solution called LY4005130 as a possible new treatment for this condition.

The purpose of the study is to compare the effectiveness of LY4005130 with placebo in adults with the disorder. Participants are randomly assigned to receive either the study drug or a dummy treatment, given by infusion over several visits during a 24‑week period. The main outcome measured is the proportion of participants who reach a 75 % improvement on the facial Vitiligo Area Scoring Index (F-VASI), a score that estimates how much of the face is repigmented. Regular check‑ins monitor safety and any changes in skin color.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial study visit
Upon joining the study, you will attend a baseline visit where basic health information and details about your vitiligo are recorded.
The study staff will explain the purpose of the trial, the procedures you will follow, and answer any questions in plain language.
Step 2
Randomization
After the baseline visit, you will be assigned by a computer system to receive either ly4005130 (the test medication) or a placebo (an inactive substance).
The assignment is randomized, meaning it is done by chance, and the study is double-blind, so you and the study staff will not know which product you receive.
Step 3
Medication administration
The assigned product will be given by intravenous infusion, which means it is delivered into a vein through a small needle.
Each infusion contains a dose of 0 mg of the study substance, prepared as a solution for injection.
Infusions are scheduled according to the study protocol and continue for a total of 24 weeks.
The exact frequency (for example, weekly or monthly) will be followed as instructed by the study team.
Step 4
Regular follow‑up visits
Throughout the 24‑week period you will return to the clinic at predetermined intervals (for example, every 4 weeks) for safety checks and to assess the effect on your vitiligo.
During each visit the study staff will measure the facial vitiligo area scoring index (f‑vasi), a simple scale that rates the amount of pigment loss on the face.
Any side effects or concerns you experience will be recorded and evaluated.
Step 5
Final assessment
At the end of week 24 you will have a final visit that includes the same assessments performed at earlier visits.
The results from the final visit will be used to determine whether the percentage of participants achieving a 75% improvement in the facial vitiligo area scoring index differs between the ly4005130 group and the placebo group.

Who can join the trial?

7 criteria

You must have been diagnosed by a doctor with non‑segmental vitiligo (NSV) for at least three months.
The affected skin area must cover between 4 % and 60 % of your total body surface, but it cannot include the palms of the hands, soles of the feet, or the top of the feet.
At least 0.5 % of the skin on your face must be affected.
Your score on the F‑VASI (a measurement of facial vitiligo severity) must be 0.5 or higher, and your score on the T‑VASI (a measurement of total body vitiligo severity) must be 3 or higher.
You can have either active disease (new or spreading spots) or stable disease (no recent change), but this must be the same at the screening visit and at the start of the study.
Both men and women are eligible to take part.
You must be in one of the age groups allowed by the study (the trial includes children and adolescents).

Who cannot join the trial?

7 criteria

Having a type of vitiligo that is not the active or stable form being studied, meaning the skin condition is different or not currently present in a steady way.
Having an active (currently occurring) other pigmentation disorder, which are conditions that change the color of the skin.
Having an active inflammatory skin disease or other skin problems that could make it hard to see how the vitiligo is responding to treatment; these are skin conditions that cause redness, swelling, or irritation.
Having a superficial skin infection (a mild infection on the surface of the skin) within two weeks before the first study visit; the infection must be cleared before re‑screening.
Having a history of chronic alcohol abuse (long‑term heavy drinking), intravenous (IV) drug use, or any illegal drug use within the past year.
Having a past or present serious illness affecting the cardiovascular (heart and blood vessels), respiratory (lungs), hepatic (liver), gastrointestinal (stomach and intestines), endocrine (hormone), hematological (blood), neurological (nerves), or neuropsychiatric (brain and mental health) systems, or any other unstable condition that the doctor believes could be risky or interfere with study results.
Having taken any JAK inhibitor medication before, either by mouth or applied to the skin (examples include ruxolitinib, tofacitinib, baricitinib, upadacitinib, filgotinib, lestaurtinib, pacritinib); participants must be completely new to these drugs.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre hospitalier universitaire de Liege
Verified
Liege, Belgium
Diamond Clinic Sp. z o.o.
Responsive
Cracow, Poland
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

Trial locations

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Investigated drugs

LY4005130 is an experimental medicine being tested to see if it can help adults with non‑segmental vitiligo, a condition that causes loss of skin color. In this study the drug is given as a sterile liquid that is injected directly into a vein. Researchers are looking at whether the medicine can safely promote the return of normal skin color and improve the appearance of the affected areas.

What is already known about the treatment

LY4005130 - LY4005130 is given as a solution for injection and is administered intravenously, meaning it is poured directly into a vein. It is an experimental compound that is still in early clinical trials and has not been approved for routine medical use. The drug is being studied to treat non‑segmental vitiligo, a condition where skin loses its color. It works by blocking a specific protein that controls immune cells, helping to calm the immune attack on pigment‑producing cells, and is classified as an investigational small‑molecule immune modulator.

Investigated diseases

Non‑segmental vitiligo
It is a chronic skin disorder in which the immune system gradually destroys pigment‑producing cells, causing white patches that usually appear in symmetrical patterns. The depigmented areas often start on the face, hands, or around body openings and can slowly enlarge over months or years. Sun exposure may make the contrast more obvious, and the patches can change in size or shape as the condition progresses.
Vitiligo
It is an acquired condition characterized by the loss of skin color due to the disappearance of melanocytes. The disease typically begins with small, light‑colored spots that may spread to larger areas over time. These patches can appear on any part of the body and often become more distinct when the surrounding skin tans. The pattern of spread varies among individuals, with some experiencing rapid expansion and others showing only modest changes.