NCT07223229

Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Elixiron Immunotherapeutics (Hong Kong) Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-segmental Vitiligo

Interventions

Type	Name	Description
BIOLOGICAL	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
OTHER	Placebo	0.9% sterile sodium chloride solution

Timeline

• Start date: 2025-12-30
• Primary completion: 2026-12-31
• Completion: 2027-09-30
• First posted: 2025-10-31
• Last updated: 2026-03-31

Locations

3 sites across 2 countries: United States, Taiwan

Regulatory

• FDA-regulated drug study