NCT07223229 Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 45 participants in total. It began in 2025-12-30 with a primary completion date of 2026-12-31.

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.

Eligibility Criteria

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.

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