Non-Segmental Vitiligo study: EB06
Official title A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
ClinicalTrials.gov ID: NCT07889492
What this study is testing
What is EB06?
EB06 is an investigational intravenous monoclonal antibody being studied as a potential treatment for moderate to severe non‑segmental vitiligo. EB06 is designed to bind and neutralize the chemokine CXCL10, which may reduce the trafficking of anti‑melanocytic T‑cells to the skin.
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
- This study is testing whether EB06 (a lab‑made antibody) is safe and helps improve skin color in adults with moderate to severe non‑segmental vitiligo.
- Who it's for
- You may be able to join if you are an adult with moderate to severe non‑segmental vitiligo.
- What's involved
- You would get a drip (IV infusion) of EB06 or a pretend treatment with no medicine. You would have doctor visits to check safety and skin changes.
- Time commitment
- The study lasts several months and includes visits for the infusion and later check‑ins.
- 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 and older
You may be able to join if
- Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 5% total BSA, and ≥ 4 T-VASI.
- Men and women ≥ 18 years of age at the time of consent.
- people who agree to discontinue all agents used to treat vitiligo from screening through to Week 28.
- Female people of childbearing potential and at risk for pregnancy: negative pregnancy test and agreement to use at least one method of effective...
- Male people with female partners of childbearing potential agree to use at least one method of effective contraception by yourself or your partner...
You likely can't join if
- people with more than 30% of poliosis within facial vitiligo areas.
- Other forms of vitiligo (e.g., segmental) or other hypopigmentation disorders (including but not limited to tinea versicolor, piebaldism, pityriasis...
- people who have used permanent depigmentation treatments, such as monobenzone, for past treatment of vitiligo.
- people who have used topical treatments applied on vitiligo affected areas such as corticosteroids, calcineurin inhibitors, phosphodiesterase-4...
- people who have used systemic immunomodulators (other than biologics, e.g., methotrexate, cyclosporin, corticosteroids, JAK inhibitors), and/or...
- people who have used laser or light-based vitiligo treatments within 4 weeks prior to Day 1.
See the full eligibility criteria
- Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 5% total BSA, and ≥ 4 T-VASI.
- Men and women ≥ 18 years of age at the time of consent.
- people who agree to discontinue all agents used to treat vitiligo from screening through to Week 28. Over the counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
- Female people of childbearing potential and at risk for pregnancy: negative pregnancy test and agreement to use at least one method of effective contraception throughout the study and for at least 12 weeks after the...
- Male people with female partners of childbearing potential agree to use at least one method of effective contraception by yourself or your partner, as applicable, during study duration and for at least 12 weeks after...
- people with more than 30% of poliosis within facial vitiligo areas.
- Other forms of vitiligo (e.g., segmental) or other hypopigmentation disorders (including but not limited to tinea versicolor, piebaldism, pityriasis alba, post-inflammatory hypopigmentation, nevus anemicus, nevus...
- people who have used permanent depigmentation treatments, such as monobenzone, for past treatment of vitiligo.
- people who have used topical treatments applied on vitiligo affected areas such as corticosteroids, calcineurin inhibitors, phosphodiesterase-4 inhibitor, retinoids or JAK inhibitors within 1 week prior to Day 1.
- people who have used systemic immunomodulators (other than biologics, e.g., methotrexate, cyclosporin, corticosteroids, JAK inhibitors), and/or melanocyte stimulating pharmaceuticals (e.g.
- people who have used laser or light-based vitiligo treatments within 4 weeks prior to Day 1.
- people who have used any biological agent or experimental procedure for vitiligo within 12 weeks or 5 half-lives (whichever is longest) prior to Day 1.
- Pregnant and/or breastfeeding people.
- people of childbearing potential who are unwilling or unable to use one method of contraception as outlined in this protocol for the duration of the study and for at least 12 weeks after the last dose of investigational...
- people who have a known history of being inadequately treated for chronic infectious disease (e.g. hepatitis B or C, human immunodeficiency virus).
- Current or recent history (\< 30 days) of a clinically meaningful bacterial, fungal, or parasitic infection.
- people with a history of malignancy in the past 5 years, except for the following adequately treated, nonmetastatic malignancies: basal cell skin cancer not involving areas with vitiligo, squamous cell carcinomas of the...
- people with other active coexisting skin (e.g. rosacea, melasma, psoriasis) and non-skin autoimmune diseases (e.g.
- people with a history of eczema herpeticum.
- Clinically significant findings or conditions which might, in the opinion of the Principal Investigator, interfere with study evaluations, pose a risk to subject safety during the study, or require treatment with an...
- people with known allergy or reaction to any component of the study formulation.
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.