vitiligo symptoms

-Percent change in F-VASI from baseline -Proportion of subjects achieving F-VASI50 -Frequency and severity of AEs and SAEs -Absolute values and percent change in F-VASI from baseline at designated time points -Absolute values and percent change in T-VASI from baseline at designated time points -Proportion of subjects achieving F-VASI50/75, T-VASI50 at designated time points

EI-001

EI-001

Infusion Solution

100 mg/10 mL

Percent change in F-VASI from baseline

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.