Phase 2 Vitiligo Trial, Recruiting NCT07712523 Sponsor: E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. Condition: Vitiligo
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Phase 2 Vitiligo Trial, Recruiting

NCT07712523
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are able to communicate clearly with the research team, understand what the trial involves including its risks, and are willing to follow all study requirements and sign a consent form before anything begins.
  • People who are aged 18 to 65 years old at the time of signing the consent form, of any gender.
  • People who have been clinically diagnosed with non-segmental vitiligo.
  • People whose vitiligo meets specific severity measurements (called F-VASI ≥ 0.5 and T-VASI ≥ 5) at both the screening and baseline visits, and whose condition is either currently active (spreading or showing new patches in the past 6 months) or stable (no signs of recent change) — (confirm with trial site for exact measurements).
  • People who agree to use effective contraception from the time of signing the consent form until 3 months after the last dose of the study drug; male participants must also agree not to donate sperm during the study and for 3 months after the last dose.
  • Women who could become pregnant must have a negative pregnancy blood test at screening and must not be breastfeeding; women who cannot become pregnant must either have had a permanent sterilisation procedure or be postmenopausal (no periods for more than 12 months for reasons other than illness, and for those under 60, a specific hormone level must be confirmed by a blood test).

Who may not be able to join:

  • People who have received certain targeted drug therapies or biological medicines within 12 weeks before the baseline visit (or longer, depending on the specific drug).
  • People who have received light-based treatments such as UVB therapy, PUVA, excimer laser, other laser treatments, or indoor tanning within 12 weeks before the baseline visit.
  • People who have taken certain whole-body (systemic) treatments within 4 weeks before the baseline visit, including immune-suppressing or immune-modifying drugs, systemic Chinese herbal or traditional medicines, or other systemic vitiligo treatments.
  • People who have used certain skin (topical) treatments within 2 weeks before the baseline visit, including steroid creams, calcineurin inhibitor creams, PDE-4 inhibitor creams, vitamin D3 creams, topical Chinese herbal preparations, or other topical vitiligo treatments.
  • People who have ever had permanent skin-lightening treatment (such as monobenzone or phenol) for vitiligo or other pigment-related conditions.
  • People who have previously had a melanocyte-keratinocyte transplant procedure or any other surgical treatment for vitiligo.
  • People who have taken strong medications known to significantly affect how the liver processes certain drugs (strong CYP3A inhibitors or inducers) within 2 weeks before the baseline visit.
  • People who have taken long-acting blood-thinning medications (such as warfarin or clopidogrel) within 4 weeks before the baseline visit, or who need to continue taking blood thinners during the study (low-dose aspirin at or below 100 mg per day is an exception).
  • People who have received or plan to receive a live or live-attenuated vaccine within 4 weeks before the baseline visit, or at any point during the study including at least 4 weeks after the last dose of the study drug.
  • People who have taken part in another clinical trial involving an experimental drug within 4 weeks before the baseline visit (or longer depending on the drug), or an experimental medical device trial within 3 months before the baseline visit.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 86-15957643460

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.
Registry
ClinicalTrials.gov
Start date
5 November 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24 of treatment.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov