Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Elixiron Immunotherapeutics (Hong Kong) Ltd.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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,
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).
You may not be if
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.
