Clinical Trials List
Protocol NumberEI-001-201
NCT Number(ClinicalTrials.gov Identfier)NCT07223229
Active
2025-09-30 - 2027-06-30
Phase II
Recruiting2
ICD-10L80
Vitiligo
ICD-9709.01
Vitiligo
A Phase 2, Randomized, Double-Blind, Placebo-controlled Proof-of-Concept Study to Evaluate the Efficacy and Safety of EI-001 in Patients with Non-segmental Vitiligo
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Trial Applicant
Syneos Health
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Sponsor
Taiwan Syneos Health Company Limited
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/14
Investigators and Locations
Principal Investigator
Co-Principal Investigator
- Chih-Hung Lee 無
- Lai San Wong 無
- 鄭裕文 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Ng Chau Yee
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Non-segmental Vitiligo
Objectives
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.
Test Drug
EI-001
Active Ingredient
EI-001
Dosage Form
Solution for intravenous infusion
Dosage
100 mg/10 mL
Endpoints
Percent change in F-VASI from baseline Week 24
Inclution Criteria
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).
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).
Exclusion Criteria
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.
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.
The Estimated Number of Participants
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Taiwan
35 participants
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Global
45 participants
