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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QY201 Tablets(5mg）, QY201 Tablets（10mg）, QY201 Tablets（20mg）, QY201 Placebo Tablets.
- Who it may be relevant to
- Registry conditions: Adult Subjects With Non-Segmental Vitiligo. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug QY201 Tablets(5mg）
One tablet twice daily for 168 consecutive days - Drug QY201 Tablets（10mg）
One tablet twice daily for 168 consecutive days - Drug QY201 Tablets（20mg）
One tablet twice daily for 168 consecutive days - Drug QY201 Placebo Tablets
One tablet twice daily for 168 consecutive days
Primary outcome measures
- 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]
Eligibility criteria
Inclusion criteria
- 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.
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).
Exclusion criteria
- 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:
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Hospital of China Medical University — Shenyang
Identifiers
NCT: NCT07712523 · QY201-204