Phase 2 EI-001 for non-segmental vitiligo
Official title: 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
Run by Elixiron Immunotherapeutics (Hong Kong) Ltd. · NCT07223229 · Data updated 2026-11-12
This trial will test whether the antibody drug EI-001 can help adults (18–65) with non‑segmental vitiligo regain skin pigment more than a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Elixiron Immunotherapeutics (Hong Kong) Ltd. Industry-sponsored |
| Locations | 8 sites (Huntington Beach, California and 7 other locations) |
| Status | Recruiting |
| Started | December 30, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | September 30, 2027 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT07223229 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with clinically diagnosed non‑segmental vitiligo affecting 5–60% total BSA (and meeting facial BSA/VASI thresholds) who have had inadequate response to or cannot use topical/oral therapies or phototherapy, and who can stop other vitiligo treatments and complete zoster vaccination if needed.
✕Probably not a fit
Patients with segmental vitiligo, very limited disease (<5% total BSA) or very extensive involvement (>60% BSA), those outside the 18–65 age range, or those who cannot discontinue other vitiligo treatments may not benefit or may not qualify for this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial gives adults with non‑segmental vitiligo either EI-001 or placebo and follows them for skin repigmentation and safety signals. EI-001 is a novel immune‑modulating antibody with preclinical data and a completed Phase 1 in healthy volunteers showing tolerability. Eligible participants must have 5–60% total body surface area affected, meet facial and VASI thresholds, and have had inadequate response or intolerance to standard topical, oral or phototherapy options. Participants must stop other vitiligo treatments during the study and complete zoster vaccination if not previously immunized.
Why it matters
Potential benefit: If successful, EI-001 could offer an additional treatment option that increases repigmentation and lowers disease activity for patients who have not responded to current local or phototherapy treatments.
How similar studies have gone: Immune‑targeting approaches including JAK inhibitors and some biologics have produced repigmentation in other vitiligo studies, but EI-001 itself is a novel antibody with only preclinical and Phase 1 tolerability data so far.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Marvel Clinical Research
Huntington Beach, California, United States Recruiting -
Skin Care Research, LLC
Hollywood, Florida, United States Recruiting -
Apex Clinical Research Center (Lorain)
Lorain, Ohio, United States Recruiting -
Apex Clinical Research Center, LLC (Mayfield)
Mayfield Heights, Ohio, United States Recruiting -
Center for Clinical Studies
Houston, Texas, United States Recruiting -
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Niao-Sung, Taiwan Recruiting
Show 2 more locations
-
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan Recruiting -
U Mass Chan Medical School
Worcester, Massachusetts, United States Withdrawn
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Test of ACT-777991 in adults with non-segmental vitiligo
This study tests whether ACT-777991 can help restore skin color in adults with non-segmental vitiligo, compared to placebo.
-
Different doses of GIA632 for adults with non-segmental vitiligo
This trial tests whether different doses of GIA632 can safely help restore skin pigment in adults with non-segmental vitiligo.
-
SHR0302 tablets with or without SHR0302 base gel for non-segmental vitiligo
This trial will test whether SHR0302 tablets, alone or together with an SHR0302 base gel, help adults with non-segmental vitiligo and are safe to use.
-
VC005 tablets for people with non-segmental vitiligo
This trial will test VC005 tablets to see if they safely help adults aged 18–70 with non-segmental vitiligo regain skin pigment.
-
Roflumilast 0.3% foam for children with non-segmental vitiligo
This trial will try a roflumilast 0.3% topical foam to see if it helps children and teens (ages 2–17) with non-segmental vitiligo affecting small areas including the face.
-
ICP-332 treatment for non-segmental vitiligo
This trial will test whether oral ICP-332 tablets help people with non-segmental vitiligo (including adolescents in the Phase III part) who have at least 5% body surface area affected and facial involvement regain skin pigment better than placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.