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
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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 co…
Interventions
- BiologicalEI-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
- OtherPlacebo
0.9% sterile sodium chloride solution
Locations (3)
- Skin Care Research, LLCHollywood, Florida
- U Mass Chan Medical SchoolWorcester, Massachusetts
- Linkou Chang Gung Memorial HospitalTaoyuan