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

Purpose

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.

Condition

  • Non-segmental Vitiligo

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Drug: EI-001
  • Biological: EI-001
    EI-001 drug product is supplied as a colorless to slightly yellow and sterile solution for infusion with a protein concentration of 10.0 mg/mL
Placebo Comparator
Drug: Placebo
  • Other: Placebo
    0.9% sterile sodium chloride solution

More Details

Status
Recruiting
Sponsor
Elixiron Immunotherapeutics (Hong Kong) Ltd.

Study Contact