Status:
RECRUITING
Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
Lead Sponsor:
Elixiron Immunotherapeutics (Hong Kong) Ltd.
Conditions:
Non-segmental Vitiligo
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 inf...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
December 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT07223229
Start Date
December 30 2025
End Date
September 30 2027
Last Update
December 30 2025
Active Locations (2)
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1
U Mass Chan Medical School Department of Dermatology
Worcester, Massachusetts, United States, 01605
2
Linkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan