A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo

Ki vehet részt

• 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
• Subjects 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 subjects 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 last dose of assigned treatment
• Male subjects 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 the last dose of assigned treatment

Ki nem vehet részt

• Subjects who have used permanent depigmentation treatments, such as monobenzone, for past treatment of vitiligo. Note: prior use of hydroquinone is not prohibited (as it is a bleaching agent, not a depigmentation treatment)
• Subjects 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
• Subjects who have used systemic immunomodulators (other than biologics, e.g., methotrexate, cyclosporin, corticosteroids, JAK inhibitors), and/or melanocyte stimulating pharmaceuticals (e.g. afamelanotide) that could affect vitiligo, or treatments that would increase skin sensitivity to ultraviolet (UV) light (e.g. 8 methoxypsoralen) within 4 weeks prior to Day 1
• Subjects who have used laser or light-based vitiligo treatments within 4 weeks prior to Day 1
• Subjects 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
• Subjects 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 product
• 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 interfering therapy
• 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 depigmentosus, senile leukoderma, chemical/drug-induced leukoderma, tuberous sclerosis, etc.)
• Subjects 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
• Subjects 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 skin not involving areas with vitiligo, or in situ cervical cancer
• Subjects with other active coexisting skin (e.g. rosacea, melasma, psoriasis) and non-skin autoimmune diseases (e.g. multiple sclerosis, etc.) which in the investigator's opinion interferes with vitiligo assessments or poses a safety risk
• Subjects with a history of eczema herpeticum
• Subjects with known allergy or reaction to any component of the study formulation
• Subjects with more than 30% of poliosis within facial vitiligo areas
• Pregnant and/or breastfeeding subjects