Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
Key facts
- Where
- Hollywood, Houston, Huntington Beach, Lorain, Mayfield Heights, and Worcester, United StatesSee the 6 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07223229, who can take part
Where in United States
- Skin Care Research, LlcHollywood, United StatesContact: Jacklyn McFaydenTaking people
- Center for Clinical StudiesHouston, United StatesContact: Mario Guerrero Site CoordinatorTaking people
- Marvel Clinical ResearchHuntington Beach, United StatesContact: Matthew Campos Site CoordinatorTaking people
- Apex Clinical Research Center (Lorain)Lorain, United StatesContact: Caroline Matyas study coordinatorTaking people
- Apex Clinical Research Center, LLC (Mayfield)Mayfield Heights, United StatesContact: Dr. Garcia Principal InvestigatorTaking people
- U Mass Chan Medical SchoolWorcester, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Elixiron Immunotherapeutics (Hong Kong) Ltd.
- Trial code
- NCT07223229
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Surgical treatments or depigmenting agents (e.g., monobenzone); High-dose steroids; Prohibited prior therapies; 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; Abnormal Medical conditions; Cardiac abnormalities; Renal impairment; 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; Clinically significant abnormal laboratory results at screening, per investigator judgment; Recent vitiligo treatments; Pregnancy or lactation; Abnormal chest X-ray.