2025-522301-37-00招募中2 期
A multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb study to assess the efficacy and safety of GIA632 in adult participants with non-segmental vitiligo followed by an extension period
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 56
研究概览
简要总结
To determine the dose-response relationship of GIA632 and evaluate the efficacy of the targeted doses compared to placebo in promoting facial skin re-pigmentation at Week 24 with respect to the percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) score, in participants with non-segmental vitiligo (NSV).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 drug- induced 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
研究组 & 干预措施
GIA632
Test
干预措施: GIA632 (Drug)
Placebo to GIA632
Placebo
干预措施: Placebo to GIA632 (Drug)
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (56)
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