A multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb study to assess the efficacy and safety of GIA632 in adult participants with nonsegmental vitiligo, followed by an extension period (CGIA632B12201)

未提供0 个研究点目标入组 20 人开始时间: 待定

适应症

试验速览

暂无简介。

•Signed informed consent must be obtained prior to participation in the study
•Male or female as assigned at birth >= 18 years of age at the time of screening
•Individuals with a diagnosis of non-segmental vitiligo and confirmation of diagnosis through physical examination by the investigator
•Non-segmental vitiligo, as assessed at screening, as
•>= 0.5% Body Surface Area (BSA) on the face and F-VASI score >= 0.5
•>= 3% BSA on non-facial areas (minimum of 3% should be calculated in addition to hands and feet) and T-VASI score = 3 to 60

•Individuals unable or unwilling to follow the study procedures and/or to complete the study-related questionnaires
•Presence of segmental or mixed vitiligo, or other skin comorbidities that may interfere with study assessments (e.g., hypopigmented mycosis fungoides, genetic diseases with pigmentary aberrations [such as piebaldism, Waardenburg, etc.], chemical- or druginduced leukoderma, etc.)
•Previous exposure to biologic drugs directly targeting IL-15 or IL-15 receptors
•Individual who previously attempted or completed depigmentation therapy for NSV
•Use of prohibited medication & treatments. Other protocol-defined inclusion/exclusion criteria may apply

发起方

未提供