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
Eli Lilly and Company
Summary
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 vitilig…
Interventions
- DrugLY4005130
Administered IV
- DrugPlacebo
Administered IV
Locations (35)
- Medical Dermatology SpecialistsPhoenix, Arizona
- Saguaro Dermatology - PhoenixPhoenix, Arizona
- Center For Dermatology Clinical Research, Inc.Fremont, California
- Northridge Clinical TrialsNorthridge, California
- Cura Clinical Research - OxnardOxnard, California
- Cura Clinical Research - Santa Clarita - Kelly Johnson ParkwaySanta Clarita, California