jRCT2071240072招募中不适用
An Open-Label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 主要终点
- Ctrough,ss
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 2age old over 至 17age old under（—）
- 性别
- All
入选标准
- •The participant weighs >=10 kg at the time of screening and enrollment into the study.
- •Participants with UC or CD diagnosed at least 1 month before screening. Participants with moderately to severely active disease defined as:
- •Participants with UC: a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of >=2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2). (The results of screening endoscopy should be applied.)
- •Participants with CD: a pediatric Crohn's disease activity index (PCDAI) >30 and a simple endoscopic score for Crohn's disease (SES-CD) >6 (or an SES-CD >=4 if disease is confined to terminal ileum) at screening endoscopy.
- •Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and/or tumor necrosis factor (TNF)-alfa antagonist therapy (eg, infliximab, adalimumab).
- •Participants with evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum.
- •Participants with extensive colitis or pancolitis of >8 years' duration or left-sided colitis of >12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.
- •Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.
排除标准
- •Participants who have had previous exposure to approved or investigational anti-integrins, including but not limited to, natalizumab, efalizumab, etrolizumab, or abrilumab (AMG 181); or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists (ontamalimab), or rituximab.
- •Participants who have had prior exposure to vedolizumab.
- •Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.
- •Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.
- •The participant has received any live vaccinations within 30 days before first dose of study drug.
- •Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.
- •Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or >3 small intestine resections.
- •Participants with a current diagnosis of indeterminate colitis.
- •Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD).
- •Participants with active or latent tuberculosis (TB).
- •Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune subjects (ie, HBsAg negative and hepatitis B surface antibody [anti-HBs]-positive) may, however, be included.
- •The participant has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
- •Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
- •Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.
结局指标
主要结局
Ctrough,ss
时间窗: Predose at Week 34
Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34
Cavg,ss
时间窗: Multiple time points prior to Week 34; pre-dose at Week 34
Average Serum Concentration at Steady-state for Vedolizumab at Week 34
次要结局
未报告次要终点
研究者
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