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

Conditions

• Non-segmental Vitiligo

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• 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
• Placebo — OTHER
  0.9% sterile sodium chloride solution

Study Details

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.

Key Dates

Start date

Dec 30, 2025

Status verified

Jun 2026

Primary completion

Dec 31, 2026

Completion

Sep 30, 2027

Study Design

Enrollment

45 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Drug: EI-001
• Placebo Comparator: Drug: Placebo

Primary Outcome Measure

Percent change in F-VASI from baseline [ Time Frame: Week 24 ]

Locations (5)

Find similar trials in Huntington Beach, CA

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