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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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

80

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • カナダ
    • Alberta
      • Edmonton、Alberta、カナダ、T6H 4J8
        • まだ募集していません
        • Vida Clinical Research
    • Ontario
      • Guelph、Ontario、カナダ、N1L 0B7
        • まだ募集していません
        • Guelph Dermatology Research
      • Newmarket、Ontario、カナダ、L3Y 5G8
        • まだ募集していません
        • Clear Skin Dermatology
      • Toronto、Ontario、カナダ、M4E 1R7
  • パナマ
      • Panama City、パナマ
        • まだ募集していません
        • CURAEX

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：プラセボ
他の：Placebo IV

Placebo IV
実験的：EB06
生物学的：EB06

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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mean percent change from baseline in F-VASI at Week 28
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Mean percent change from baseline in F-VASI at Weeks 24 and 32
時間枠：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.
時間枠：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
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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).
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Edesa Biotech Inc.

協力者

JSS Medical Research Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年8月5日

一次修了 (推定)

2027年12月1日

研究の完了 (推定)

2027年12月1日

試験登録日

最初に提出

2026年10月16日

QC基準を満たした最初の提出物

2026年10月16日

最初の投稿 (実際)

2026年10月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月6日

QC基準を満たした最後の更新が送信されました

2026年11月5日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • EB06-12-2022

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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