Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients

ConditionNon-segmental Vitiligo

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorElixiron Immunotherapeutics (Hong Kong) Ltd.

About this trial

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

Qualifiers

Able to understand and voluntarily sign the informed consent form (ICF).

Male or female, aged 18-65 years at the time of consent.

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.

Disqualifiers

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)