Overview
Vitiligo Research Study
A clinical study to see if an investigational medicine could help restore the skin's natural color.
Vitiligo happens when your body's immune system mistakenly attacks the cells that give your skin its color, causing lighter or white patches to appear. But vitiligo isn't just about what you see on the skin. It can affect how you feel about yourself, interact with others, and go about your daily life. While treatments are available, results are often not as noticeable or long-lasting as people hope.
Vitiligo is a chronic, autoimmune condition that presents as depigmented macules and patches, resulting from the loss of functional melanocytes. Although vitiligo is an autoimmune condition, it is frequently mischaracterized as a cosmetic or trivial condition. Those affected often experience significant quality-of-life challenges including depression and anxiety, social isolation, and work absence.
Table of Contents
About this Study
This is a multicenter, randomized, double-blind, placebo-controlled study to investigate the safety and efficacy of an investigational treatment in participants with non-segmental vitiligo. The product is an investigational monoclonal antibody that binds to and inhibits IL-15. IL-15 is implicated in vitiligo pathogenesis through the activation and persistence of autoreactive CD8+ T cells and the maintenance of tissue-resident memory T cells (TRMs) in lesions and perilesional skin. In this study, we’re hoping to find a safe and effective dose of the investigational medicine.
We’re conducting a vitiligo research study to see if an investigational medicine could help restore the skin’s natural color for people living with vitiligo. Current treatment options are limited; there are currently no systemic medications that repigment affected areas, and many people do not see meaningful improvements with current treatments. Therefore, there remains a high clinical need for more effective and safer treatments.
What This Means for You
This vitiligo research study is researching a potential new treatment for adults living with vitiligo, a condition where the skin loses its natural color in patches. Vitiligo can affect different areas of the body and may impact confidence and quality of life.
Researchers are studying an investigational treatment designed to help restore skin pigmentation. The treatment is still being evaluated to understand how well it works and how safe it is for people with vitiligo.
Some participants in this study may receive a placebo, which looks like the study treatment but does not contain active medicine. This helps researchers compare results and better understand the effectiveness of the treatment.
The goal of this study is to learn whether this new treatment can safely improve skin repigmentation in people with non-segmental vitiligo over time.
The study team or your study doctor will explain what this means for you in detail.
Who Can Join
The sponsor is looking for around 210 people to join this vitiligo research study.
You may be able to participate if you:
- Are 18 years of age or older
- Have been diagnosed with non-segmental vitiligo
- Have vitiligo affecting more than 5% of your body surface area
- Have tried at least one topical (skin-applied) treatment in the past 3 months without success, or have been told by their doctor that there is no suitable topical medication
You may not be eligible if you:
- Have previously used certain advanced or biologic treatments for vitiligo
- Have not responded to certain systemic (whole-body) treatments in the past
- Have undergone surgical treatments or depigmentation procedures for vitiligo
- Are currently taking medications that may interfere with the study (the study team will review this with you)
- Have segmental or mixed vitiligo, or other skin conditions
Not sure if you qualify?
A member of our study team will review your medical history and medications with you to determine if this vitiligo research study may be a good fit for you.
You may also qualify for other studies.
What to Expect
Here’s what to expect if you join this vitiligo research study:
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Study Duration: Up to 1 year and 4 months or up to 112 weeks with the optional extension period included
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Study Visits: During this time, you’ll have up to 31-48 clinic visits. Most visits will take approximately 2 hours.
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Investigational Medicine: You’ll be assigned to receive either the investigational medicine or a placebo. Neither you nor the study team will know which one you’re being given.
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Administration: You’ll receive your assigned study medicine as subcutaneous (under the skin) injections. Each dose is given as two injections. You’ll receive one dose every week for 3 weeks, and then every 2 weeks after that.
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Optional Extension: Participants who complete the core period will be given the option to join the extension period for an additional 1 year. All participants who join the extension period will be given the investigational medicine.
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Compensation: You may be paid (reimbursed) for reasonable time and travel costs.
If you have any other questions about what to expect from this vitiligo research study, feel free to ask the study team or your study doctor.