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RECRUITING
NCT07223229
PHASE2

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

Sponsor: Elixiron Immunotherapeutics (Hong Kong) Ltd.

View on ClinicalTrials.gov

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

Interventions

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

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