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

2026年11月5日 更新者：Edesa Biotech Inc.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo

The purpose of this study is to evaluate the safety and efficacy of EB06 intravenous infusion (loading dose of 20mg/kg followed by a maintenance dose of 10mg/kg) compared with placebo in adults with moderate to severe non-segmental vitiligo..

Vitiligo is a chronic autoimmune skin disorder characterized by the loss of skin pigmentation due to the destruction of melanocytes. EB06 is a fully human monoclonal antibody that binds and neutralizes CXCL10, a chemokine implicated in the trafficking of anti-melanocytic T-cells to the epidermis and in inducing cell death. Elevated levels of CXCL10 have been associated with both the initiation of the disease and the maintenance of vitiligo lesions. The study will evaluate the safety, tolerability, and efficacy of EB06 in adults with moderate to severe non-segmental vitiligo.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

80

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T6H 4J8
        • 尚未招聘
        • Vida Clinical Research
    • Ontario
      • Guelph、Ontario、加拿大、N1L 0B7
        • 尚未招聘
        • Guelph Dermatology Research
      • Newmarket、Ontario、加拿大、L3Y 5G8
        • 尚未招聘
        • Clear Skin Dermatology
      • Toronto、Ontario、加拿大、M4E 1R7
  • 巴拿马
      • Panama City、巴拿马
        • 尚未招聘
        • CURAEX

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. 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.
  2. Men and women ≥ 18 years of age at the time of consent.
  3. 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.
  4. 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.
  5. 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.

Exclusion Criteria:

  1. Subjects with more than 30% of poliosis within facial vitiligo areas.
  2. 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.).
  3. 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).
  4. 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.
  5. 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.
  6. Subjects who have used laser or light-based vitiligo treatments within 4 weeks prior to Day 1.
  7. 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.
  8. Pregnant and/or breastfeeding subjects.
  9. 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.
  10. Subjects who have a known history of being inadequately treated for chronic infectious disease (e.g. hepatitis B or C, human immunodeficiency virus).
  11. Current or recent history (< 30 days) of a clinically meaningful bacterial, fungal, or parasitic infection.
  12. 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.
  13. 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.
  14. Subjects with a history of eczema herpeticum.
  15. 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.
  16. Subjects with known allergy or reaction to any component of the study formulation.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
其他：Placebo IV

Placebo IV
实验性的：EB06
生物：EB06

EB06 IV loading 20 mg/kg followed by 10 mg/kg

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Mean percent change from baseline in F-VASI at Week 28
大体时间：28 Weeks

The Facial Vitiligo Area Scoring Index (F-VASI) is a validated assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement. The primary endpoint is the mean percent change from baseline in F-VASI at Week 28. A greater reduction from baseline reflects greater improvement in facial vitiligo.
28 Weeks

次要结果测量

结果测量
措施说明
大体时间
Mean percent change from baseline in F-VASI at Weeks 24 and 32
大体时间：Weeks 24 and 32

Difference in mean change from baseline in F-VASI.

F VASI is an assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement.
Weeks 24 and 32
Proportion of subjects achieving F VASI50 at Weeks 24, 28 and 32.
大体时间：Weeks 24, 28, and 32

Proportion of subjects achieving at least 50% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI).

F VASI is an assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement.
Weeks 24, 28, and 32
Time to achieving F-VASI50
大体时间：Baseline through Week 32

Time from baseline to first achievement of at least 50% improvement from baseline in F-VASI.

F VASI is an assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement.
Baseline through Week 32
Mean percent change from baseline in the T-VASI at Weeks 24, 28 and 32.
大体时间：Weeks 24, 28, and 32

Mean percent change from baseline in Total Body VASI (T-VASI).

T-VASI is a measure of total body vitiligo extent and depigmentation severity, with scores ranging from 0 to 100, where higher scores indicate greater vitiligo involvement.
Weeks 24, 28, and 32
Proportion of subjects achieving T VASI50 at Weeks 24, 28 and 32.
大体时间：Weeks 24, 28, and 32

Proportion of subjects achieving at least 50% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI).

T-VASI is a measure of total body vitiligo extent and depigmentation severity, with scores ranging from 0 to 100, where higher scores indicate greater vitiligo involvement.
Weeks 24, 28, and 32
Proportion of subjects achieving F-VASI75 at Weeks 24, 28 and 32.
大体时间：Weeks 24, 28, and 32

Proportion of subjects achieving at least 75% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI).

F VASI is an assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement.
Weeks 24, 28, and 32
Proportion of subjects achieving a score of 4 (a lot less noticeable) or 5 (no longer noticeable) on the Vitiligo Noticeability Scale (VNS) at Weeks 24, 28 and 32.
大体时间：Weeks 24, 28, and 32.

Proportion of subjects achieving a VNS score of 4 (a lot less noticeable) or 5 (no longer noticeable)

VNS is a patient-reported 5-point assessment of how noticeable facial vitiligo appears compared with before treatment, where a score of 1 indicates "more noticeable" and a score of 5 indicates "no longer noticeable.
Weeks 24, 28, and 32.
Time to achieving a score of 4 (a lot less noticeable) or 5 (no longer noticeable) on the Vitiligo Noticeability Scale (VNS).
大体时间：Baseline through Week 32

Time from baseline to first achievement of a VNS score of 4 or 5.

VNS is a patient-reported 5-point assessment of how noticeable facial vitiligo appears compared with before treatment, where a score of 1 indicates "more noticeable" and a score of 5 indicates "no longer noticeable.
Baseline through Week 32
Proportion of subjects achieving a Face Patient Global Impression of Change-Vitiligo (F-PaGIC-V) score of 1, 2, or 3 at Weeks 24, 28, and 32.
大体时间：Weeks 24, 28, and 32

Proportion of subjects achieving a Face Patient Global Impression of Change-Vitiligo (F-PaGIC-V) score of 1, 2, or 3.

F-PaGIC V (Facial Patient Global Impression of Change-Vitiligo) is a patient-reported assessment of change in facial vitiligo since baseline using a 7-point scale ranging from 1 (very much improved) and 7 (very much worse).
Weeks 24, 28, and 32
Proportion of subjects achieving a Total Patient Global Impression of Change-Vitiligo (T-PaGIC-V) score of 1, 2, or 3 at Weeks 24, 28, and 32.
大体时间：Weeks 24, 28, and 32

Proportion of subjects achieving a Total Patient Global Impression of Change-Vitiligo (T-PaGIC-V) score of 1, 2, or 3.

T-PaGIC V (Total Patient Global Impression of Change-Vitiligo) is a patient-reported assessment of change in overall body vitiligo since baseline using a 7-point scale ranging from 1 (very much improved) and 7 (very much worse).
Weeks 24, 28, and 32
Proportion of subjects achieving a facial static investigator global assessment (F-sIGA) of 0 or 1, with at least a 2-point reduction from baseline at Week 24, 28 and Week 32.
大体时间：Weeks 24, 28, and 32

Proportion of subjects achieving a facial static investigator global assessment (F-sIGA) of 0 or 1, with at least a 2-point reduction from baseline.

F-sIGA (Facial Static Investigator Global Assessment) is an investigator-assessed measure of facial vitiligo severity using a 5-point scale of ranging from 0 (clear) to 4 (severe vitiligo).
Weeks 24, 28, and 32
Proportion of subjects achieving a total body static investigator global assessment (T-sIGA) of 0 or 1, with at least a 2-point reduction from baseline at Week 24, 28 and Week 32.
大体时间：Weeks 24, 28, and 32

Proportion of subjects achieving a total body static investigator global assessment (T-sIGA) of 0 or 1, with at least a 2-point reduction from baseline.

T-sIGA (Total Static Investigator Global Assessment) is an investigator-assessed measure of overall body vitiligo severity using a 5-point scale ranging from 0 (clear) to 4 (severe vitiligo).
Weeks 24, 28, and 32
Mean percent change from baseline in Body Surface Area (BSA) affected with depigmentation at Week 24, 28 and Week 32.
大体时间：Weeks 24, 28, and 32

Mean percent change from baseline in Body Surface Area (BSA) affected with depigmentation.

BSA is an investigator-assessed measure of the percentage of total body surface area affected by vitiligo and reflects the extent of disease involvement.
Weeks 24, 28, and 32

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Edesa Biotech Inc.

合作者

JSS Medical Research Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月5日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年10月16日

首先提交符合 QC 标准的

2026年10月16日

首次发布 (实际的)

2026年10月22日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • EB06-12-2022

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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