💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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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