Non-Segmental Vitiligo (NSV), Vitiligo
Conditions
Brief 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.
Interventions
DRUGLY4005130
Administered IV
DRUGPlacebo
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI) 75 | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 75 | Week 24 |
| Pharmacodynamics (PD): Change from Baseline in Gene Expression of Select Genes from Skin Biopsy | Baseline, Week 24 |
| Pharmacokinetics (PK): Observed Trough of LY4005130 Serum Concentration | Week 24 |
Countries
Belgium, Canada, China, Poland, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed