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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
Skin Care Research, LLC
Hollywood, Florida, United States
NOT_YET_RECRUITINGU Mass Chan Medical School Department of Dermatology
Worcester, Massachusetts, United States
NOT_YET_RECRUITINGLinkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan
RECRUITINGPercent change in F-VASI from baseline
Time frame: Week 24
Proportion of subjects achieving F-VASI50
F-VASI50 is defined as at least 50% improvement in F-VASI from baseline
Time frame: Week 24
Frequency and severity of AEs and SAEs
Including the results of physical examinations, vital signs, evaluation of clinical laboratory studies, and ECG
Time frame: Week 32
Absolute values and percent change in F-VASI from baseline at designated time points
Time frame: Week 22
Absolute values and percent change in T-VASI from baseline at designated time points
Time frame: Week 22
Proportion of subjects achieving F-VASI50/75, T-VASI50 at designated time points
F-VASI75 is defined as at least 75% improvement in F-VASI from baseline T-VASI50 is defined as at least 50% improvement in T-VASI from baseline
Time frame: Week 22
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