New drug aims to restore skin color in vitiligo patients
NCT ID NCT07223229
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new drug called EI-001 can help people with vitiligo, a condition that causes white patches on the skin. The drug works by calming the immune system to reduce inflammation. About 45 adults with nonsegmental vitiligo will receive either EI-001 or a placebo to see if it improves skin color and is safe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
-
Sep 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Non-segmental vitiligo are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
5 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
-
Apex Clinical Research Center, LLC (Mayfield)
RECRUITINGMayfield Heights, Ohio, 44124, United States
Contact Email: •••••@•••••
-
Center for Clinical Studies
RECRUITINGHouston, Texas, 77004, United States
-
Linkou Chang Gung Memorial Hospital
RECRUITINGTaoyuan, Taiwan
-
Marvel Clinical Research
RECRUITINGHuntington Beach, California, 17742, United States
-
Skin Care Research, LLC
RECRUITINGHollywood, Florida, 33021, United States
-
U Mass Chan Medical School
WITHDRAWNWorcester, Massachusetts, 01605, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an experimental pill help teenagers with vitiligo?
- New pill aims to bring back color to vitiligo skin
- New pill could help restore skin color in vitiligo patients
- Can a pill keep vitiligo at bay? new study aims to find out
- New hope for vitiligo: experimental drug aims to restore skin color
- New hope for vitiligo: experimental drug aims to bring back skin color