NCT07223229RecruitingPhase 2
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
Elixiron Immunotherapeutics (Hong Kong) Ltd.6 sites in 2 countries45 target enrollmentStarted: December 30, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 6
- Primary Endpoint
- Percent change in F-VASI from baseline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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) ≥
- •Agree to discontinue all vitiligo treatments from screening until final follow-up.
- •If not previously vaccinated against zoster, agree to complete vaccination before Day
- •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.
Arms & Interventions
Drug: Placebo
Placebo Comparator
Intervention: Placebo (Other)
Drug: EI-001
Experimental
Intervention: EI-001 (Biological)
Outcomes
Primary Outcomes
Percent change in F-VASI from baseline
Time Frame: Week 24
Secondary Outcomes
- Absolute values and percent change in T-VASI from baseline at designated time points(Week 22)
- Absolute values and percent change in F-VASI from baseline at designated time points(Week 22)
- Proportion of subjects achieving F-VASI50(Week 24)
- Frequency and severity of AEs and SAEs(Week 32)
- Proportion of subjects achieving F-VASI50/75, T-VASI50 at designated time points(Week 22)
Investigators
Study Sites (6)
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