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

NCT07223229 | Recruiting Phase 2 FDA Drug

• 1 other identifier: EI-001-201
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percent change in F-VASI from baseline

  Week 24

Secondary Outcomes (5)

• Proportion of subjects achieving F-VASI50

  Week 24

• Frequency and severity of AEs and SAEs

  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

  Week 22

Study Arms (2)

Drug: EI-001

EXPERIMENTAL

Biological: EI-001

Drug: Placebo

PLACEBO COMPARATOR

Other: Placebo

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

Drug: EI-001

Placebo OTHER

0.9% sterile sodium chloride solution

Drug: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 contraindications, intolerance, or unsuitability.
• Depigmentation extent meeting all of the following:
• 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.
• Agree to discontinue all vitiligo treatments from screening until final follow-up.
• If not previously vaccinated against zoster, agree to complete vaccination before Day 1.
• Contraception
• Not applicable to females of non-childbearing potential (surgically sterile or postmenopausal ≥12 months, confirmed by FSH at screening).

You may not qualify if:

• Non-eligible skin conditions: Other types of vitiligo (e.g., segmental) or other depigmentation disorders (e.g., piebaldism, leprosy, post-inflammatory hypopigmentation, tinea versicolor, etc.), or ≥30% leukotrichia on face or body.
• Psychiatric risk
• Recent vitiligo treatments
• Surgical treatments or depigmenting agents (e.g., monobenzone)
• High-dose steroids
• Pregnancy or lactation
• Abnormal Medical conditions
• Prohibited prior therapies
• Cardiac abnormalities
• Abnormal chest X-ray
• Renal impairment
• Clinically significant abnormal laboratory results at screening, per investigator judgment.
• Viral infections:
• Hypersensitivity: Known allergy or severe reaction to EI-001 or its excipients.
• Compliance concerns: Any condition that would make it difficult for the subject to follow the study schedule, receive treatment, attend visits, or could interfere with study objectives, data interpretation, or participant safety.

Sponsors & Collaborators

• Elixiron Immunotherapeutics (Hong Kong) Ltd.: lead

Study Sites (3)

Skin Care Research, LLC

Hollywood, Florida, 33021, United States

NOT YET RECRUITING

U Mass Chan Medical School

Worcester, Massachusetts, 01605, United States

WITHDRAWN

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Interventions

BL-EI001

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: October 31, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

TW (1); US (2)