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

A Phase 2, Randomized, Double-Blind, Placebo-controlled Proof-of-Concept Study to Evaluate the Efficacy and Safety of EI-001 in Patients With Nonsegmental Vitiligo

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.

Study Overview

• Status: Recruiting
• Conditions: Non-segmental Vitiligo
• Intervention / Treatment: Other: Placebo; Biological: EI-001

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan District, Taiwan
    • Recruiting
    • Linkou Chang Gung Memorial Hospital
    • Contact: Wen-Leng Chou; Phone Number: +886 922216828; Email: a5896067@yahoo.com.tw
• United States
  • Florida
    • Hollywood, Florida, United States, 33021
      • Not yet recruiting
      • Skin Care Research, LLC
      • Contact: Jacklyn McFayden; Phone Number: 954-674-3535; Email: jmcfayden@dermcaremgt.com
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Withdrawn
      • U Mass Chan Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Drug: Placebo	Other: Placebo; 0.9% sterile sodium chloride solution
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in F-VASI from baseline	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects achieving F-VASI50	F-VASI50 is defined as at least 50% improvement in F-VASI from baseline	Week 24
Frequency and severity of AEs and SAEs	Including the results of physical examinations, vital signs, evaluation of clinical laboratory studies, and ECG	Week 32
Absolute values and percent change in F-VASI from baseline at designated time points		Week 22
Absolute values and percent change in T-VASI from baseline at designated time points		Week 22
Proportion of subjects achieving F-VASI50/75, T-VASI50 at designated time points	F-VASI75 is defined as at least 75% improvement in F-VASI from baseline T-VASI50 is defined as at least 50% improvement in T-VASI from baseline	Week 22

Collaborators and Investigators

• Sponsor: Elixiron Immunotherapeutics (Hong Kong) Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: October 29, 2025
• First Submitted That Met QC Criteria: October 29, 2025
• First Posted (Actual): October 31, 2025

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: BL-EI001
• Other Study ID Numbers: EI-001-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No