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

A vizsgálat adatai

Ki végzi

Elixiron Immunotherapeutics (Hong Kong) Ltd.

Azonosító

NCT07223229

A regiszteradat frissítve

2026. november 2.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

A Phase 2, Randomized, Double-Blind, Placebo-controlled Proof-of-Concept Study to Evaluate the Efficacy and Safety of EI-001 in Patients With Nonsegmental Vitiligo

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.

Bevonási feltételek: 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).

Kizáró feltételek: Surgical treatments or depigmenting agents (e.g., monobenzone); High-dose steroids; Prohibited prior therapies; 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; Abnormal Medical conditions; Cardiac abnormalities; Renal impairment; 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; Clinically significant abnormal laboratory results at screening, per investigator judgment; Recent vitiligo treatments; Pregnancy or lactation; Abnormal chest X-ray.

ClinicalTrials.gov NCT07223229