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

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 Overview

• Status: Recruiting
• Conditions: Adult Subjects With Non-Segmental Vitiligo
• Intervention / Treatment: Drug: QY201 Tablets(5mg）; Drug: QY201 Tablets（10mg）; Drug: QY201 Tablets（20mg）; Drug: QY201 Placebo Tablets

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Li Qiang; Phone Number: 86-15957643460; Email: qiang.li@enitiatebio.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110002
      • Recruiting
      • The First Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. At the time of ICF signature, the subject is aged ≥18 and ≤65 years old, with no restriction on gender.
3. Clinically diagnosed with non-segmental vitiligo at screening.

4. 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.

   Stable vitiligo: defined as absence of any signs of disease activity.

5. 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).

Exclusion Criteria:

1. 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.

2. 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.

3. 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.

4. Received any of the following topical treatments within 2 weeks prior to baseline:

   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.

5. Has a history of permanent depigmentation therapy (e.g., monobenzone, phenol) for vitiligo and/or other pigmentary disorders at any time prior to screening.
6. Has a history of melanocyte-keratinocyte transplantation procedure (MKTP) or other surgical interventions for vitiligo.
7. Taken strong inhibitors or strong inducers of cytochrome P450 3A (CYP3A) hepatic metabolic enzymes within 2 weeks prior to baseline.
8. 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).
9. 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).
10. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QY201 Tablets（5mg）; One tablet twice daily for 168 consecutive days	Drug: QY201 Tablets(5mg）; One tablet twice daily for 168 consecutive days
Experimental: QY201 Tablets（10mg）; One tablet twice daily for 168 consecutive days	Drug: QY201 Tablets（10mg）; One tablet twice daily for 168 consecutive days
Experimental: QY201 Tablets（20mg）; One tablet twice daily for 168 consecutive days	Drug: QY201 Tablets（20mg）; One tablet twice daily for 168 consecutive days
Placebo Comparator: QY201 Placebo Tablets; One tablet twice daily for 168 consecutive days	Drug: QY201 Placebo Tablets; One tablet twice daily for 168 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 24 of protocol-specified treatment

Collaborators and Investigators

• Sponsor: E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: QY201-204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No