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Recruiting NCT07223229

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

Phase II Interventional Non-segmental Vitiligo

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EI-001, Placebo.
Who it may be relevant to
Registry conditions: Non-segmental Vitiligo. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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
  • Other Placebo
    0.9% sterile sodium chloride solution

Primary outcome measures

  • Percent change in F-VASI from baseline [Time frame: Week 24]
Secondary outcome measures (5)
  • Proportion of subjects achieving F-VASI50 [Time frame: Week 24]
  • Frequency and severity of AEs and SAEs [Time frame: Week 32]
  • Absolute values and percent change in F-VASI from baseline at designated time points [Time frame: Week 22]
  • Absolute values and percent change in T-VASI from baseline at designated time points [Time frame: Week 22]
  • Proportion of subjects achieving F-VASI50/75, T-VASI50 at designated time points [Time frame: Week 22]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Marvel Clinical Research — Huntington Beach
  • Skin Care Research, LLC — Hollywood
  • U Mass Chan Medical School — Worcester
  • Apex Clinical Research Center, LLC (Mayfield) — Mayfield Heights
  • Center for Clinical Studies — Houston
Taiwan · 1 center
  • Linkou Chang Gung Memorial Hospital — Taoyuan

Identifiers

NCT: NCT07223229 · EI-001-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗