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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: EI-001 | Experimental |
| |
| Drug: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EI-001 | Biological | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in F-VASI from baseline | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving F-VASI50 | F-VASI50 is defined as at least 50% improvement in F-VASI from baseline | Week 24 |
| Frequency and severity of AEs and SAEs | Including the results of physical examinations, vital signs, evaluation of clinical laboratory studies, and ECG |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marvel Clinical Research | Recruiting | Huntington Beach | California | 17742 | United States |
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| ID | Term |
|---|---|
| C000604216 | BL-EI001 |
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| Placebo | Other | 0.9% sterile sodium chloride solution |
|
| Week 32 |
| Absolute values and percent change in F-VASI from baseline at designated time points | Week 22 |
| Absolute values and percent change in T-VASI from baseline at designated time points | 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 | Week 22 |
| Skin Care Research, LLC | Recruiting | Hollywood | Florida | 33021 | United States |
|
| U Mass Chan Medical School | Withdrawn | Worcester | Massachusetts | 01605 | United States |
| Apex Clinical Research Center, LLC (Mayfield) | Recruiting | Mayfield Heights | Ohio | 44124 | United States |
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| Center for Clinical Studies | Recruiting | Houston | Texas | 77004 | United States |
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| Linkou Chang Gung Memorial Hospital | Recruiting | Taoyuan | Taiwan |
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