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
This study will test whether intravenous LY4005130 is safe and what side effects it may cause in adults with non-segmental vitiligo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | ruxolitinib, tofacitinib, baricitinib, upadacitinib, filgotinib, lestaurtinib, pacritinib |
| Locations | 35 sites (Phoenix, Arizona and 34 other locations) |
| Trial ID | NCT07533019 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
- Medical Dermatology Specialists — Phoenix, Arizona, United States (Not_yet_recruiting)
- Saguaro Dermatology - Phoenix — Phoenix, Arizona, United States (Not_yet_recruiting)
- Center For Dermatology Clinical Research, Inc. — Fremont, California, United States (Not_yet_recruiting)
- Northridge Clinical Trials — Northridge, California, United States (Not_yet_recruiting)
- Cura Clinical Research - Oxnard — Oxnard, California, United States (Not_yet_recruiting)
- Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway — Santa Clarita, California, United States (Not_yet_recruiting)
- Health Clinical Research, LLC — Miami, Florida, United States (Recruiting)
- K2 Medical Research - Tampa — Tampa, Florida, United States (Not_yet_recruiting)
- Advanced Medical Research, PC. — Sandy Springs, Georgia, United States (Not_yet_recruiting)
- Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States (Not_yet_recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Revival Research Institute, LLC — Troy, Michigan, United States (Not_yet_recruiting)
- Stracskin — Portsmouth, New Hampshire, United States (Not_yet_recruiting)
- Equity Medical — The Bronx, New York, United States (Not_yet_recruiting)
- Accurate Clinical Research, Inc — Humble, Texas, United States (Not_yet_recruiting)
- Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue — San Antonio, Texas, United States (Not_yet_recruiting)
- Jordan Valley Dermatology & Research Center — South Jordan, Utah, United States (Not_yet_recruiting)
- Clinical Research Partners, LLC — Richmond, Virginia, United States (Not_yet_recruiting)
- ANIMA Research — Alken, Belgium (Not_yet_recruiting)
- UZ Gent — Ghent, Belgium (Not_yet_recruiting)
- Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman — Liège, Belgium (Not_yet_recruiting)
- INTERMED Groupe Sante — Chicoutimi, Canada (Not_yet_recruiting)
- DermEffects — London, Canada (Not_yet_recruiting)
- Dar Clinical Research - Ottawa - Hunt Club Road — Ottawa, Canada (Not_yet_recruiting)
- The Centre for Dermatology — Richmond Hill, Canada (Not_yet_recruiting)
- Research Toronto — Toronto, Canada (Not_yet_recruiting)
- SIMa Recherche — Verdun, Canada (Not_yet_recruiting)
- Peking University People's Hospital — Beijing, China (Not_yet_recruiting)
- Hangzhou Third People's Hospital — Hangzhou, China (Not_yet_recruiting)
- Shanghai Skin Disease Hospital — Shanghai, China (Not_yet_recruiting)
- The University of Hong Kong-Shenzhen Hospital — Shenzhen, China (Not_yet_recruiting)
- Centrum Badan Klinicznych PI-House sp. z o.o. — Gdansk, Poland (Not_yet_recruiting)
- Diamond Clinic — Krakow, Poland (Not_yet_recruiting)
- Dermedic Jacek Zdybski — Ostrowiec Świętokrzyski, Poland (Not_yet_recruiting)
- Centrum Medyczne Ginemedica — Wroclaw, Poland (Not_yet_recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.