Non-segmental VitiligoPhase 2NCT07223229
Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
A Phase 2 study testing EI-001 in people with Non-segmental Vitiligo, run by Elixiron Immunotherapeutics (Hong Kong) Ltd. at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-segmental Vitiligo
- What is being tested?
- EI-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 30 Dec 2025to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States5 sites, 4 recruiting
- Recruiting
Skin Care Research, LLC
Hollywood, Florida, 33021
Jacklyn McFayden, 954-674-3535, jmcfayden@dermcaremgt.com
- Recruiting
Center for Clinical Studies
Houston, Texas, 77004
Mario Guerrero Site Coordinator, 713-528-8818 ext. 1203, mguerrero@ccstexas.com
- Recruiting
Marvel Clinical Research
Huntington Beach, California, 17742
Matthew Campos Site Coordinator, 714-375-5970, mcampos@marvelclinical.com
- Recruiting
Apex Clinical Research Center, LLC (Mayfield)
Mayfield Heights, Ohio, 44124
Dr. Garcia Principal Investigator, 440-940-2739, research@apexskin.com
- Withdrawn
U Mass Chan Medical School
Worcester, Massachusetts, 01605
Taiwan1 site, 1 recruiting
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan
Wen-Leng Chou, +886 922216828, a5896067@yahoo.com.tw
About this study
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
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.
- Conditions
- Non-segmental Vitiligo
- Being tested
- EI-001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EI-001Biological
EI-001 drug product is supplied as a colorless to slightly yellow and sterile solution for infusion with a protein concentration of 10.0 mg/mL
PlaceboOther
0.9% sterile sodium chloride solution
| Study group | Role | What they receive |
|---|---|---|
| Drug: EI-001 | Experimental | Not described Receives: Biological: EI-001 |
| Drug: Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in F-VASI from baseline
Measured: Week 24
Secondary outcomes (5)
Proportion of subjects achieving F-VASI50
F-VASI50 is defined as at least 50% improvement in F-VASI from baseline
Measured: Week 24
Frequency and severity of AEs and SAEs
Including the results of physical examinations, vital signs, evaluation of clinical laboratory studies, and ECG
Measured: Week 32
Absolute values and percent change in F-VASI from baseline at designated time points
Measured: Week 22
Absolute values and percent change in T-VASI from baseline at designated time points
Measured: Week 22
Proportion of subjects achieving F-VASI50/75, T-VASI50 at designated time points
F-VASI75 is defined as at least 75% improvement in F-VASI from baseline T-VASI50 is defined as at least 50% improvement in T-VASI from baseline
Measured: Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start30 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-segmental VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elixiron Immunotherapeutics (Hong Kong) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223229
- Sponsor's protocol ID
- EI-001-201
- Status last verified
- Jun 2026
- First submitted
- 29 Oct 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07223229
- Acronym / sponsor ID
- EI-001-201
- Conditions
- Non-segmental Vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Elixiron Immunotherapeutics (Hong Kong) Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 31 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: EI-001 | Experimental | Biological: EI-001 |
| Drug: Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EI-001EI-001 drug product is supplied as a colorless to slightly yellow and sterile solution for infusion with a protein concentration of 10.0 mg/mL | Biological | Drug: EI-001 |
| Placebo0.9% sterile sodium chloride solution | Other | Drug: Placebo |
Primary outcome
Percent change in F-VASI from baseline
Time frame: Week 24
5 secondary outcomes
Proportion of subjects achieving F-VASI50
Time frame: Week 24
Frequency and severity of AEs and SAEs
Time frame: Week 32
Absolute values and percent change in F-VASI from baseline at designated time points
Time frame: Week 22
Absolute values and percent change in T-VASI from baseline at designated time points
Time frame: Week 22
Proportion of subjects achieving F-VASI50/75, T-VASI50 at designated time points
Time frame: Week 22
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Apex Clinical Research Center, LLC (Mayfield)
Mayfield Heights, United States
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EI-001 in people with Non-segmental Vitiligo, run by Elixiron Immunotherapeutics (Hong Kong) Ltd. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in F-VASI from baseline (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.