Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
Trial Parameters
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 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.
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. * Con