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

Elixiron Immunotherapeutics (Hong Kong) Ltd.

Status and phase

Enrolling

Phase 2

Conditions

Non-segmental Vitiligo

Treatments

Other: Placebo

Biological: EI-001

Study type

Interventional

Funder types

Industry

Identifiers

NCT07223229

EI-001-201

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.