Actively Recruiting
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of EI-001 in Adults With Nonsegmental Vitiligo
Led by Elixiron Immunotherapeutics (Hong Kong) Ltd. · Updated on 2026-06-05
45
Participants Needed
6
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug EI-001 in adults with non-segmental vitiligo, a condition causing skin depigmentation. EI-001 is a new antibody designed to reduce uncontrolled inflammation by affecting the immune system. It has been studied in lab cultures, animal tests, and a Phase 1 trial with healthy volunteers, showing it may be a tolerable option for immune-related diseases like vitiligo. This Phase 2 study compares EI-001 to a placebo in a randomized, double-blind design. EI-001 is given as a sterile infusion with a protein concentration of 10.0 mg/mL. Participants receive either EI-001 or a placebo consisting of saline solution. The study measures changes in vitiligo symptoms over 24 weeks, with safety monitored through 32 weeks. Participants will be involved in regular visits for assessments including skin evaluations with the Facial Vitiligo Area Scoring Index (F-VASI) and Total Vitiligo Area Scoring Index (T-VASI). Researchers will track symptom changes, side effects, and immune responses. The study lasts about 32 weeks from treatment start, with follow-ups to observe safety and treatment effects.
CONDITIONS
Brief Title
Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign the informed consent form.
- Male or female, aged 18-65 years at consent.
- Body Mass Index (BMI) between 18 and 38 kg/m² and weight at least 40 kg.
- Clinically diagnosed with non-segmental vitiligo for at least 3 months.
- Have had inadequate response to approved vitiligo treatments or are unable to use them due to contraindications, intolerance, or unsuitability.
- Depigmentation extent: Facial BSA �3 0.5%, Facial VASI �3 0.5, Total BSA between 5% and 60%, Total VASI �3 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.
- For females of childbearing potential, use contraception unless surgically sterile or postmenopausal for at least 12 months confirmed by FSH at screening.
You will not qualify if you...
- Other types of vitiligo (e.g., segmental) or other depigmentation disorders.
- More than 30% leukotrichia on face or body.
- Psychiatric risks that may interfere with study participation.
- Recent vitiligo treatments including surgical or depigmenting agents.
- Use of high-dose steroids.
- Pregnancy or lactation.
- Cardiac abnormalities or abnormal chest X-ray.
- Renal impairment or clinically significant abnormal lab results.
- Known allergy or severe reaction to EI-001 or its ingredients.
- Conditions making it difficult to follow the study schedule or affecting safety or data quality.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive either the EI-001 drug or placebo to treat non-segmental vitiligo.
Regular visits during the treatment period
Duration - 8 weeks
Participants are monitored for safety and long-term effects after the treatment period.
Visits up to Week 32
Trial Site Locations
Total: 6 locations
1
Marvel Clinical Research
Huntington Beach, California, United States, 17742
Actively Recruiting
2
Skin Care Research, LLC
Hollywood, Florida, United States, 33021
Actively Recruiting
3
U Mass Chan Medical School
Worcester, Massachusetts, United States, 01605
Withdrawn
4
Apex Clinical Research Center, LLC (Mayfield)
Mayfield Heights, Ohio, United States, 44124
Actively Recruiting
5
Center for Clinical Studies
Houston, Texas, United States, 77004
Actively Recruiting
6
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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