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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

地位

尚未招聘

研究类型

介入性

注册 (估计的)

108

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Key Inclusion Criteria

  1. Participant must be at least 18 years of age or have reached the legal age of consent in their country, whichever is higher.
  2. 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.
  3. 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.
  4. 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

  1. 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.
  2. HS-Lack of adequate response, as determined by the investigator.
  3. 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.
  4. BP- Participants with any pemphigoid disease other than classic BP, BP secondary to medications, or any severe comorbid illness.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月30日

初级完成 (估计的)

2029年3月13日

研究完成 (估计的)

2029年3月13日

研究注册日期

首次提交

2026年11月6日

首先提交符合 QC 标准的

2026年11月6日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月6日

最后验证

2026年11月1日

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)?

是的

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

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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