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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 78
- 主要终点
- Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) score.
研究概览
简要总结
The main purpose of this multicenter, randomized, double-blind, placebo-controlled Phase 2b study is to investigate the safety and efficacy of GIA632 in participants with NSV and to identify the optimal dose to be promoted into the confirmatory Phase 3 program.
详细描述
This trial in adult participants ≥ 18 years with non-segmental vitiligo (NSV) consists of a randomized, double-blind, placebo-controlled period to establish and characterize the dose-response relationship of GIA632 and estimate the targeted doses treatment effect compared with placebo, followed by the assessment of longer term safety and efficacy in extension period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 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 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
研究组 & 干预措施
GIA632 Arm 2
GIA632 will be administered during the 48-week core period.
干预措施: GIA632 (Drug)
GIA632 Arm 3
GIA632 will be administered during the 48-week core period.
干预措施: GIA632 (Drug)
GIA632 Arm 4
GIA632 will be administered during the 48-week core period.
干预措施: GIA632 (Drug)
GIA632 Arm 1
GIA632 will be administered during the 48-week core period.
干预措施: GIA632 (Drug)
Placebo
Placebo will be administered during the 48-week core period.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) score.
时间窗: Baseline, Week 24
The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas.
次要结局
- Achievement of ≥75% improvement from baseline in the F-VASI (F-VASI75)(Baseline, Week 24)
- Percentage change from baseline in Total body Vitiligo Area Scoring Index (T-VASI) score.(Baseline, Week 24)
- Achievement of ≥50% improvement from baseline in T-VASI (T-VASI50)(Baseline, Week 24)
- Achievement of F-VASI50, F-VASI75, and FVASI90(Baseline, Week 12, Week 24, Week 36, and Week 48)
- Achievement of T-VASI50, T-VASI75, and TVASI90(Baseline, Week 12, Week 24, Week 36, and Week 48.)
- Achievement of Vitiligo Noticeability Scale Score (VNS) of 4 or 5(Week 12, Week 24, Week 36, and at Week 48.)