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

Exclusion Criteria13

• 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.