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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY4005130 		LY4005130 administered intravenously (IV)
  • Drug: LY4005130
    Administered IV
Placebo Comparator
Placebo 		Placebo administered IV
  • Drug: Placebo
    Administered IV

Recruiting Locations

Medical Dermatology Specialists
Phoenix, Arizona 85006
Contact:
602-354-5770

Center For Dermatology Clinical Research, Inc.
Fremont, California 94538
Contact:
510-797-0140

Northridge Clinical Trials
Northridge, California 91325
Contact:
818-350-7482

Cura Clinical Research - Oxnard
Oxnard, California 93030
Contact:
833-525-2872

Health Clinical Research, LLC
Miami, Florida 33189
Contact:
786-280-1977

K2 Medical Research - Tampa
Tampa, Florida 33634
Contact:
813-800-5252

Advanced Medical Research, PC.
Sandy Springs, Georgia 30328

Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
Contact:
317-516-5030

Revival Research Institute, LLC
Troy, Michigan 48084
Contact:
248-590-0298

Stracskin
Portsmouth, New Hampshire 03801
Contact:
617-833-9995

Equity Medical
The Bronx, New York 10455

Accurate Clinical Research, Inc
Humble, Texas 77346
Contact:
281-760-3930

Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
San Antonio, Texas 78235
Contact:
210-852-2779

Jordan Valley Dermatology & Research Center
South Jordan, Utah 84095

Clinical Research Partners, LLC
Richmond, Virginia 23226
Contact:
804-477-3045

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.