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New treatment option for Non-segmental Vitiligo
Official title Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
ClinicalTrials.gov ID: NCT07223229
What this study is testing
What is EI-001?
EI-001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-segmental vitiligo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Inadequate response to approved treatments:
- Topical therapy (e.g., corticosteroids, calcineurin inhibitors, or JAK inhibitors) ≥ 3 months,
You likely can't join if
- Non-eligible skin conditions: Other types of vitiligo (e.g., segmental) or other depigmentation disorders (e.g., piebaldism, leprosy...
- Psychiatric risk
- Recent vitiligo treatments
- Surgical treatments or depigmenting agents (e.g., monobenzone)
- High-dose steroids
- Pregnancy or lactation
See the full eligibility 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).
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Huntington Beach, California, United States
- Hollywood, Florida, United States
- Worcester, Massachusetts, United States
- Mayfield Heights, Ohio, United States
- Houston, Texas, United States
- Taoyuan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntington Beach, California, United States; Hollywood, Florida, United States; Worcester, Massachusetts, United States; Mayfield Heights, Ohio, United States; Houston, Texas, United States; Taoyuan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.