Идёт набор NCT07223229

Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients

Фаза II С лечением Non-segmental Vitiligo

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: EI-001, Placebo.
Кому может быть актуально: Состояния в реестре: Non-segmental Vitiligo. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Тайвань
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Биопрепарат EI-001
EI-001 drug product is supplied as a colorless to slightly yellow and sterile solution for infusion with a protein concentration of 10.0 mg/mL
Другое Placebo
0.9% sterile sodium chloride solution

Первичные конечные точки

Percent change in F-VASI from baseline [Срок оценки: Week 24]

Вторичные конечные точки (5)

Proportion of subjects achieving F-VASI50 [Срок оценки: Week 24]
Frequency and severity of AEs and SAEs [Срок оценки: Week 32]
Absolute values and percent change in F-VASI from baseline at designated time points [Срок оценки: Week 22]
Absolute values and percent change in T-VASI from baseline at designated time points [Срок оценки: Week 22]
Proportion of subjects achieving F-VASI50/75, T-VASI50 at designated time points [Срок оценки: Week 22]

Критерии участия

Критерии включения

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) ≥ 5.

Agree to discontinue all vitiligo treatments from screening until final follow-up.
If not previously vaccinated against zoster, agree to complete vaccination before Day 1.
Contraception
Not applicable to females of non-childbearing potential (surgically sterile or postmenopausal ≥12 months, confirmed by FSH at screening).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет