Recruiting
Phase 2

EI-001

Sponsor:

Elixiron Immunotherapeutics (Hong Kong) Ltd.

Code:

NCT07223229

Conditions

Non-segmental Vitiligo

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

EI-001

Placebo

Study Details

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

Study ID

NCT07223229

Start date

Dec 30, 2025

Status verified date

Jun, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 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).

Exclusion Criteria:

  • 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.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Drug: EI-001

placebo comparator: Drug: Placebo

Interventions

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

Placebo

0.9% sterile sodium chloride solution

Primary outcome measure

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

Central Contacts and Locations

Locations

Marvel Clinical Research

Recruiting

Huntington Beach, California, United States, 17742

Contacts

Matthew Campos Site Coordinator

714-375-5970mcampos@marvelclinical.com

Skin Care Research, LLC

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Jacklyn McFayden

954-674-3535jmcfayden@dermcaremgt.com

Apex Clinical Research Center, LLC (Mayfield)

Recruiting

Mayfield Heights, Ohio, United States, 44124

Contacts

Dr. Garcia Principal Investigator

440-940-2739research@apexskin.com

Center for Clinical Studies

Recruiting

Houston, Texas, United States, 77004

Contacts

Mario Guerrero Site Coordinator

713-528-8818mguerrero@ccstexas.com

More Information

Sponsor

Elixiron Immunotherapeutics (Hong Kong) Ltd.

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Elixiron Immunotherapeutics (Hong Kong) Ltd. on 2026-06-05.