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Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
Sponsor: Elixiron Immunotherapeutics (Hong Kong) Ltd.
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2025-12-30
Completion Date
2027-09-30
Last Updated
2026-06-05
Healthy Volunteers
No
Conditions
Interventions
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
Placebo
0.9% sterile sodium chloride solution
Locations (6)
Marvel Clinical Research
Huntington Beach, California, United States
Skin Care Research, LLC
Hollywood, Florida, United States
U Mass Chan Medical School
Worcester, Massachusetts, United States
Apex Clinical Research Center, LLC (Mayfield)
Mayfield Heights, Ohio, United States
Center for Clinical Studies
Houston, Texas, United States
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan