Actively Recruiting
Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
Led by Elixiron Immunotherapeutics (Hong Kong) Ltd. · Updated on 2026-03-31
45
Participants Needed
3
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 (ICF).
- Male or female, aged 18-65 years at the time of consent.
- BMI between 18 and 38 kg/m² and weight at least 40 kg at consent.
- Clinically diagnosed non-segmental vitiligo (NSV) for at least 3 months.
- Inadequate response to approved treatments: topical therapy for at least 3 months, phototherapy for at least 6 months, or oral therapy for at least 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) at least 0.5%, Facial VASI (F-VASI) at least 0.5, Total BSA between 5% and 60%, Total VASI (T-VASI) at least 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 requirements apply unless female is of non-childbearing potential (surgically sterile or postmenopausal 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 (e.g., piebaldism, leprosy, post-inflammatory hypopigmentation, tinea versicolor).
- Leukotrichia on face or body greater than or equal to 30%.
- Psychiatric risks.
- Recent vitiligo treatments including surgical treatments or depigmenting agents such as monobenzone.
- Use of 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 as judged by investigator.
- Viral infections.
- Known allergy or severe reaction to EI-001 or its excipients.
- Any condition making it difficult to follow study schedule, receive treatment, attend visits, or interfering with study objectives, data interpretation, or participant safety.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Skin Care Research, LLC
Hollywood, Florida, United States, 33021
Not Yet Recruiting
2
U Mass Chan Medical School
Worcester, Massachusetts, United States, 01605
Withdrawn
3
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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