Adult Subjects With Non-Segmental VitiligoPhase 2NCT07712523
A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of QY201 Tablets in Subjects With Non-Segmental Vitiligo
A Phase 2 study testing QY201 Tablets(5mg）, QY201 Tablets（10mg） and QY201 Tablets（20mg） in people with Adult Subjects With Non-Segmental Vitiligo, run by E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy of QY201 Tablets in adult subjects with non-segmental vitiligo, and to provide evidence for dose selection in the confirmatory Phase III clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adult Subjects With Non-Segmental Vitiligo
- What is being tested?
- QY201 Tablets(5mg）, QY201 Tablets（10mg） and QY201 Tablets（20mg）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2025to 31 Dec 2026
- 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
- The subject is able to communicate well with investigators, fully understands the purpose, nature, methods and potential adverse reactions of this trial, voluntarily participates as a study subject, comprehends and complies with all requirements of this research, and signs the Informed Consent Form (ICF) prior to initiation of any study procedures.
- At the time of ICF signature, the subject is aged ≥18 and ≤65 years old, with no restriction on gender.
- Clinically diagnosed with non-segmental vitiligo at screening.
- Subjects must meet the following criteria at screening and baseline:
- F-VASI ≥ 0.5 and T-VASI ≥ 5 at both screening and baseline; The disease is in progressive (active) phase or stable phase at screening and baseline.
- Progressive vitiligo: defined as appearance of new lesions or enlargement of existing lesions within the past 6 months (confirmed by photographs or medical records), or presence of confetti lesions, trichrome lesions, or Koebner phenomenon.
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- Stable vitiligo: defined as absence of any signs of disease activity.
- The subject (and partner if applicable) agrees to avoid pregnancy and adopt effective contraceptive measures from ICF signature through 3 months after the last study drug administration.
- Male subjects: must commit not to donate sperm during the study period and within 3 months after the last study medication.
- Female subjects:
- Women of childbearing potential: have a negative serum human chorionic gonadotropin (HCG) test at screening and are not breastfeeding.
- Women without childbearing potential: have undergone permanent sterilization (e.g., bilateral oophorectomy, bilateral salpingectomy, hysterectomy), or are postmenopausal (defined as amenorrhea for more than 12 months excluding other pathological causes of amenorrhea; subjects under 60 years old must have serum follicle-stimulating hormone (FSH) > 40 IU/L).
Who cannot join
- Received any of the following treatments within 12 weeks prior to baseline (or 5 half-lives, whichever is longer):
- Small-molecule targeted drugs; Macromolecular biological agents.
- Received phototherapy (e.g., ultraviolet B [UVB], psoralen plus ultraviolet A [PUVA], excimer laser or other laser modalities, etc.) including indoor tanning within 12 weeks prior to baseline.
- Received any of the following systemic therapies within 4 weeks prior to baseline (or 5 half-lives, whichever is longer):
- Systemic immunosuppressive or immunomodulatory drugs; Systemic Chinese herbal medicines or proprietary Chinese medicines; Other systemic medications indicated for vitiligo treatment.
- Received any of the following topical treatments within 2 weeks prior to baseline:
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- Topical corticosteroids (TCS); Topical calcineurin inhibitors (TCI); Topical phosphodiesterase 4 (PDE-4) inhibitors; Topical vitamin D3 analogues; Topical Chinese herbal preparations or herbal bathing for external use; Other topical drugs for vitiligo management.
- Has a history of permanent depigmentation therapy (e.g., monobenzone, phenol) for vitiligo and/or other pigmentary disorders at any time prior to screening.
- Has a history of melanocyte-keratinocyte transplantation procedure (MKTP) or other surgical interventions for vitiligo.
- Taken strong inhibitors or strong inducers of cytochrome P450 3A (CYP3A) hepatic metabolic enzymes within 2 weeks prior to baseline.
- Received long-acting anticoagulants (e.g., warfarin, clopidogrel, etc.) within 4 weeks prior to baseline, or requires continuous anticoagulant therapy (excluding aspirin at a dose ≤100 mg per day).
- Planned to receive live or attenuated live vaccines within 4 weeks prior to baseline; or expects to receive live or attenuated live vaccines during the study period (including at least 4 weeks after the last dose of investigational product).
- Has participated in any clinical trial involving an investigational drug within 4 weeks prior to baseline (or 5 half-lives, whichever is longer), or any clinical trial with an investigational medical device within 3 months prior to baseline.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110002
About this study
To evaluate the efficacy of QY201 Tablets in adult subjects with non-segmental vitiligo, and to provide evidence for dose selection in the confirmatory Phase III clinical trial.
- Being tested
- QY201 Tablets(5mg）, QY201 Tablets（10mg）, QY201 Tablets（20mg）, QY201 Placebo Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QY201 Tablets(5mg）Drug
One tablet twice daily for 168 consecutive days
QY201 Tablets（10mg）Drug
One tablet twice daily for 168 consecutive days
QY201 Tablets（20mg）Drug
One tablet twice daily for 168 consecutive days
QY201 Placebo TabletsDrug
One tablet twice daily for 168 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| QY201 Tablets（5mg） | Experimental | One tablet twice daily for 168 consecutive days Receives: Drug: QY201 Tablets(5mg） |
| QY201 Tablets（10mg） | Experimental | One tablet twice daily for 168 consecutive days Receives: Drug: QY201 Tablets（10mg） |
| QY201 Tablets（20mg） | Experimental | One tablet twice daily for 168 consecutive days Receives: Drug: QY201 Tablets（20mg） |
| QY201 Placebo Tablets | Placebo comparator | One tablet twice daily for 168 consecutive days Receives: Drug: QY201 Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24 of treatment.
To evaluate the difference in the percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) between the treatment group and the placebo group in subjects with non-segmental vitiligo after completion of 24 weeks of protocol-specified treatment. Subjects who discontinue treatment prematurely due to poor efficacy, or receive prohibited concomitant medications specified in the protocol that interfere with efficacy evaluation on account of insufficient therapeutic effect, will be regarded as treatment failures.
Measured: Week 24 of protocol-specified treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start5 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Subjects With 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712523
- Sponsor's protocol ID
- QY201-204
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of QY201 Tablets in Subjects With Non-Segmental Vitiligo
- ClinicalTrials.gov ID
- NCT07712523
- Acronym / sponsor ID
- QY201-204
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jul 2026 (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.
To evaluate the efficacy of QY201 Tablets in adult subjects with non-segmental vitiligo, and to provide evidence for dose selection in the confirmatory Phase III clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QY201 Tablets（5mg） | Experimental | Drug: QY201 Tablets(5mg）One tablet twice daily for 168 consecutive days |
| QY201 Tablets（10mg） | Experimental | Drug: QY201 Tablets（10mg）One tablet twice daily for 168 consecutive days |
| QY201 Tablets（20mg） | Experimental | Drug: QY201 Tablets（20mg）One tablet twice daily for 168 consecutive days |
| QY201 Placebo Tablets | Placebo comparator | Drug: QY201 Placebo TabletsOne tablet twice daily for 168 consecutive days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The subject is able to communicate well with investigators, fully understands the purpose, nature, methods and potential adverse reactions of this trial, voluntarily participates as a study subject, comprehends and complies with all requirements of this research, and signs the Informed Consent Form (ICF) prior to initiation of any study procedures.
- At the time of ICF signature, the subject is aged ≥18 and ≤65 years old, with no restriction on gender.
- Clinically diagnosed with non-segmental vitiligo at screening.
- Subjects must meet the following criteria at screening and baseline:
- F-VASI ≥ 0.5 and T-VASI ≥ 5 at both screening and baseline; The disease is in progressive (active) phase or stable phase at screening and baseline.
Key exclusion criteria (13 listed)
- Received any of the following treatments within 12 weeks prior to baseline (or 5 half-lives, whichever is longer):
- Small-molecule targeted drugs; Macromolecular biological agents.
- Received phototherapy (e.g., ultraviolet B [UVB], psoralen plus ultraviolet A [PUVA], excimer laser or other laser modalities, etc.) including indoor tanning within 12 weeks prior to baseline.
- Received any of the following systemic therapies within 4 weeks prior to baseline (or 5 half-lives, whichever is longer):
- Systemic immunosuppressive or immunomodulatory drugs; Systemic Chinese herbal medicines or proprietary Chinese medicines; Other systemic medications indicated for vitiligo treatment.
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 |
|---|---|---|
| QY201 Tablets(5mg）One tablet twice daily for 168 consecutive days | Drug | QY201 Tablets（5mg） |
| QY201 Tablets（10mg）One tablet twice daily for 168 consecutive days | Drug | QY201 Tablets（10mg） |
| QY201 Tablets（20mg）One tablet twice daily for 168 consecutive days | Drug | QY201 Tablets（20mg） |
| QY201 Placebo TabletsOne tablet twice daily for 168 consecutive days | Drug | QY201 Placebo Tablets |
Primary outcome
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24 of treatment.
Time frame: Week 24 of protocol-specified treatment
To evaluate the difference in the percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) between the treatment group and the placebo group in subjects with non-segmental vitiligo after completion of 24 weeks of protocol-specified treatment. Subjects who discontinue treatment prematurely due to poor efficacy, or receive prohibited concomitant medications specified in the protocol that interfere with efficacy evaluation on account of insufficient therapeutic effect, will be regarded as treatment failures.
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 17 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QY201 Tablets(5mg）, QY201 Tablets（10mg） and QY201 Tablets（20mg） in people with Adult Subjects With Non-Segmental Vitiligo, run by E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.
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 12 inclusion and 13 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact Li Qiang (86-15957643460, qiang.li@enitiatebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24 of treatment. (time frame: Week 24 of protocol-specified treatment). 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 17 Jul 2026.