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Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
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
Who can join
Ages 18 to 65 · All sexes
Full eligibility criteria
Inclusion 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). 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.
About the study
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.
What is being tested
- EI-001 (biological)
- Placebo (other)
Sponsor: Elixiron Immunotherapeutics (Hong Kong) Ltd. · Participants: 45 · Started: Dec 30, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT07223229
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.