VIS954 for Treating Inflammatory Skin Problems
A Phase 2a, Multicenter, Basket Study of VIS954 in Participants With Inflammatory Skin Diseases
This is a phase 2, multicenter, basket study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of VIS954 in adults with inflammatory skin diseases (ISDs).
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名:Otsuka Call Center
- 电话号码:844-687-8522
- 邮箱:otsuka-professionalservices@otsuka-us.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria
- Participant must be at least 18 years of age or have reached the legal age of consent in their country, whichever is higher.
- HS- Adults with moderate-to-severe HS of at least 6 months' duration, classified as Hurley Stage II or III, with an inadequate response, intolerance, or contraindication to prior standard systemic antibiotic therapy.
- PG-Adults with clinically confirmed moderate-to-severe ulcerative PG requiring systemic therapy and presenting with at least one active ulcerative lesion of less than 6 months' duration.
- BP-Adults with newly diagnosed or relapsing classical BP, confirmed by clinical presentation and direct immunofluorescence and/or BP180/BP230 serology, with moderate disease activity.
Key Exclusion Criteria
- Participants cannot join the study if they have another active skin condition, medical condition, or mental health condition that, in the study doctor's opinion, could affect the study results, increase safety risks, require restricted medications during the study, or make participation unsuitable.
- HS-Lack of adequate response, as determined by the investigator.
- PG-Presence of active infection involving the target ulcer or non-PG mimics that may interfere with assessment of pyoderma gangrenosum disease activity or treatment response.
- BP- Participants with any pemphigoid disease other than classic BP, BP secondary to medications, or any severe comorbid illness.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:HS Cohort: VIS954
Participants with Hidradenitis Suppurativa (HS) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
安慰剂比较:HS Cohort: Placebo
Participants with HS will receive placebo in the placebo-controlled period. |
VIS954-matching placebo solution for injection |
|
实验性的:PG Cohort: VIS954
Participants with Pyoderma Gangrenosum (PG) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
安慰剂比较:PG Cohort: Placebo
Participants with PG will receive placebo in the placebo-controlled period. |
VIS954-matching placebo solution for injection |
|
实验性的:BP Cohort: VIS954
Participants with Bullous Pemphigoid (BP) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
安慰剂比较:BP Cohort: Placebo
Participants with BP received placebo in the placebo-controlled period. |
VIS954-matching placebo solution for injection |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Adverse Events (AEs) and AEs Related to Infection
大体时间:Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Laboratory Abnormalities' Events
大体时间:Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Vital Signs' Events
大体时间:Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Physical Examination Events
大体时间:Up to Week 36
|
Up to Week 36
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
HS, PG, and BP Cohorts: C5aR1 Percentage Receptor Occupancy on Circulating Neutrophils
大体时间:Predose and at multiple timepoints postdose up to Day 225
|
Predose and at multiple timepoints postdose up to Day 225
|
|
HS, PG, and BP Cohorts: Maximum Plasma Concentration (Cmax) of VIS954
大体时间:Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Time to Reach Maximum Plasma Concentration (tmax) of VIS954
大体时间:Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUCtau)
大体时间:Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Terminal Elimination Half-life (t1/2z)
大体时间:Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Apparent Clearance (CL/F)
大体时间:Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Apparent Volume of Distribution (Vz/F)
大体时间:Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 381-201-00028
- 2026-525969-41-00 (克蒂斯)
- 1014049 (其他标识符:Integrated Research Application System (IRAS))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
IPD 共享时间框架
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD 共享访问标准
Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
药物和器械信息、研究文件
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