JPRN-jRCT2031200371招募中3 期
An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who Experienced Secondary Loss of Response During Maintenance Therapy with Vedolizumab IV Administered Every 8 Weeks (Q8W)
Shikamura Mitsuhiro0 个研究点目标入组 158 人开始时间: 2021年2月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 158
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1. The participant has moderate to severe UC, who had previously shown clinical response in initial treatment with commercially available vedolizumab IV, then experienced secondary loss of response during maintenance therapy with commercially available vedolizumab IV Q8W.
- •Previous clinical response is to be judged by the investigators referring to one of the following criteria.
- •- Reduction of >=2 points and >=25% in modified Mayo score, and a decrease of >=1 point in rectal bleeding subscore or rectal bleeding subscore of =<1, from the start of initial treatment with commercially available vedolizumab IV.
- •- Reduction of >=2 points and >=25% in partial Mayo score, and a decrease of >=1 point in rectal bleeding subscore or rectal bleeding subscore of =<1, from the start of initial treatment with commercially available vedolizumab IV.
- •- Significant improvement on endoscopy (i.e., a decrease of >=2 points in Mayo endoscopic subscore).
- •Secondary loss of response is to be judged by the investigators referring to one of the following criteria.
- •- Increase of >=2 points in modified Mayo score, and an increase of >=1 point in rectal bleeding subscore or rectal bleeding subscore >=2, from the start of maintenance therapy with commercially available vedolizumab IV.
- •- Increase of >=2 points in partial Mayo score, and an increase of >=1 point in rectal bleeding subscore or rectal bleeding subscore >=2, from the start of maintenance therapy with commercially available vedolizumab IV.
- •- Significant deterioration on endoscopy (i.e., an increase of >=2 points in Mayo endoscopic subscore).
- •2. The participant has active UC as determined by a modified Mayo score of >=5 at baseline (within 10 days prior to the start of treatment phase), with a Mayo rectal bleeding subscore of >=1 at baseline (within 10 days prior to the start of treatment phase) and a Mayo endoscopic subscore of >=1 as assessed by the central reader.
- •1. The participant has moderate to severe CD, who had previously shown clinical response in initial treatment with commercially available vedolizumab IV, then experienced secondary loss of response during maintenance therapy with commercially available vedolizumab IV Q8W.
- •Previous clinical response is to be judged by the investigators referring to one of the following criteria.
- •- Reduction of >=70 points in CDAI score from the start of initial treatment with commercially available vedolizumab IV.
- •- Reduction of >=3 points in HBI score from the start of initial treatment with commercially available vedolizumab IV.
- •Secondary loss of response is to be judged by the investigators referring to one of the following criteria.
- •- Increase of >=70 points in CDAI score from the start of maintenance therapy with commercially available vedolizumab IV.
- •- Increase of >=3 points in HBI score from the start of maintenance therapy with commercially available vedolizumab IV.
- •2. The participant has active CD as determined by a CDAI score of >=220 at baseline (within 10 days prior to the start of treatment phase).
- •3. The participant has a C-reactive protein (CRP) level >3.0 mg/L during the screening phase.
排除标准
- •1. The participant has had extensive colonic resection, subtotal or total colectomy.
- •2. The participant has received any of the investigational or approved non-biologic therapies (e.g., cyclosporine, tacrolimus or tofacitinib, except for those specifically listed as permitted medications) ) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer).
- •3. The participant has received any investigational or approved biologic or biosimilar agent other than vedolizumab within 60 days or 5 half-lives of screening (whichever is longer).
- •4. The participant has a clinically significant active infection (e.g., pneumonia, pyelonephritis or coronavirus disease 2019 [COVID-19]) within 30 days prior to screening or during screening, or has an ongoing chronic infection, or has lingering COVID-19-related symptoms, if previously infected with COVID-19..
- •5. The subject has known or suspected intolerance or hypersensitivity to vedolizumab or closely related compounds, or any of the vedolizumab IV excipients.
- •6. The subject has active cerebral/meningeal disease, or signs/symptoms of progressive multifocal
- •leukoencephalopathy (PML) or any history of PML at screening.
研究者
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