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

Обзор

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.

Вмешательства

• Препарат QY201 Tablets(5mg）
  One tablet twice daily for 168 consecutive days
• Препарат QY201 Tablets（10mg）
  One tablet twice daily for 168 consecutive days
• Препарат QY201 Tablets（20mg）
  One tablet twice daily for 168 consecutive days
• Препарат QY201 Placebo Tablets
  One tablet twice daily for 168 consecutive days

Первичные конечные точки

• Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24 of treatment. [Срок оценки: Week 24 of protocol-specified treatment]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Hospital of China Medical University — Шэньян

Идентификаторы

NCT: NCT07712523 · QY201-204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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