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New treatment option for Vitiligo
Official title A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
ClinicalTrials.gov ID: NCT07533019
What this study is testing
What is LY4005130?
LY4005130 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for vitiligo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- BSA involvement of ≥0.5% on the face
- F-VASI ≥0.5 and T-VASI ≥3, and
You likely can't join if
- 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...
- 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...
See the full eligibility 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Fremont, California, United States
- Northridge, California, United States
- Oxnard, California, United States
- Santa Clarita, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Sandy Springs, Georgia, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Troy, Michigan, United States
- Portsmouth, New Hampshire, United States
- The Bronx, New York, United States
- Humble, Texas, United States
- San Antonio, Texas, United States
- South Jordan, Utah, United States
- Richmond, Virginia, United States
- Diepenbeek, Belgium
- Ghent, Belgium
- Liège, Belgium
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Fremont, California, United States; Northridge, California, United States; Oxnard, California, United States; Santa Clarita, California, United States; Miami, Florida, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.