NCT07223229招募中2 期
A Phase 2, Randomized, Double-Blind, Placebo-controlled Proof-of-Concept Study to Evaluate the Efficacy and Safety of EI-001 in Patients With Nonsegmental Vitiligo
Elixiron Immunotherapeutics (Hong Kong) Ltd.6 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2025年12月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Percent change in F-VASI from baseline
研究概览
简要总结
The primary purpose of this study is to evaluate whether the drug EI-001 can help improve vitiligo symptoms. EI-001 is a novel antibody drug that affects the immune system to decrease uncontrolled inflammation. EI-001 has been investigated in human cell cultures, animal studies, and in a Phase 1 healthy volunteer study. The results so far show that EI-001 is a tolerable and potential new treatment for immune diseases such as vitiligo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and voluntarily sign the informed consent form (ICF).
- •Male or female, aged 18-65 years at the time of consent.
- •BMI 18-38 kg/m² and weight ≥ 40 kg at consent. Clinically diagnosed non-segmental vitiligo (NSV) for at least 3 months, and meets one of the following:
- •Inadequate response to approved treatments:
- •Topical therapy (e.g., corticosteroids, calcineurin inhibitors, or JAK inhibitors) ≥ 3 months,
- •Phototherapy ≥ 6 months, or Oral therapy (e.g., corticosteroids, calcineurin inhibitors) ≥ 3 months.
- •Or unable to use these treatments due to contraindications, intolerance, or unsuitability.
- •Depigmentation extent meeting all of the following:
- •Facial BSA (F-BSA) ≥ 0.5%, Facial VASI (F-VASI) ≥ 0.5, Total BSA (T-BSA) between 5% and 60%, Total VASI (T-VASI) ≥
- •Agree to discontinue all vitiligo treatments from screening until final follow-up.
- •If not previously vaccinated against zoster, agree to complete vaccination before Day
- •Contraception
- •Not applicable to females of non-childbearing potential (surgically sterile or postmenopausal ≥12 months, confirmed by FSH at screening).
排除标准
- •Non-eligible skin conditions: Other types of vitiligo (e.g., segmental) or other depigmentation disorders (e.g., piebaldism, leprosy, post-inflammatory hypopigmentation, tinea versicolor, etc.), or ≥30% leukotrichia on face or body.
- •Psychiatric risk
- •Recent vitiligo treatments
- •Surgical treatments or depigmenting agents (e.g., monobenzone)
- •High-dose steroids
- •Pregnancy or lactation
- •Abnormal Medical conditions
- •Prohibited prior therapies
- •Cardiac abnormalities
- •Abnormal chest X-ray
- •Renal impairment
- •Clinically significant abnormal laboratory results at screening, per investigator judgment.
- •Viral infections:
- •Hypersensitivity: Known allergy or severe reaction to EI-001 or its excipients.
- •Compliance concerns: Any condition that would make it difficult for the subject to follow the study schedule, receive treatment, attend visits, or could interfere with study objectives, data interpretation, or participant safety.
研究组 & 干预措施
Drug: Placebo
Placebo Comparator
干预措施: Placebo (Other)
Drug: EI-001
Experimental
干预措施: EI-001 (Biological)
结局指标
主要结局
Percent change in F-VASI from baseline
时间窗: Week 24
次要结局
- Absolute values and percent change in T-VASI from baseline at designated time points(Week 22)
- Absolute values and percent change in F-VASI from baseline at designated time points(Week 22)
- Proportion of subjects achieving F-VASI50(Week 24)
- Frequency and severity of AEs and SAEs(Week 32)
- Proportion of subjects achieving F-VASI50/75, T-VASI50 at designated time points(Week 22)
研究者
研究点 (6)
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