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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Non-segmental Vitiligo

In brief

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 facts

Study ID

NCT07223229

Run by

Elixiron Immunotherapeutics (Hong Kong) Ltd.

People needed

45

Starts

2025-12-30

Expected to finish

2027-09-30

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Marvel Clinical Research — Huntington Beach, California, United States (enrolling)
• Skin Care Research, LLC — Hollywood, Florida, United States (enrolling)
• Apex Clinical Research Center, LLC (Mayfield) — Mayfield Heights, Ohio, United States (enrolling)
• Center for Clinical Studies — Houston, Texas, United States (enrolling)
• Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan (enrolling)
• U Mass Chan Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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