2023-509046-36-00招募中3 期
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 23
- 主要终点
- For the Treatment Cohort: The primary endpoint for this study is the incidence of adverse events (AEs).
研究概览
简要总结
The primary objective of the treatment cohort is to evaluate the safety profile of long-term vedolizumab IV treatment in pediatric subjects with UC or CD.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Long-tern extension study
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •In the opinion of the investigator, the subject, or subject`s legally authorized representative, subject`s parent, or legal guardian (adult caregiver) is capable of understanding and complying with protocol requirements.
- •The subject, subject’s legally authorized representative or adult caregive signs and dates a written, informed consent and/or pediatric assent form and any required privacy authorization before the initiation of any study procedures, as required per local regulations.
- •The subject is male or female with UC or CD and aged <18 years. (Note: Subjects who reach adult age [18 years of age in most jurisdictions/regions] during the study should be considered to transition to commercial drug if available in their country, especially if transition to an adult care setting is required by local regulation.).
- •The subject has completed Study MLN0002-3024 or Study MLN0002-3025 and has achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from baseline for subjects with UC; or a reduction of PCDAI of ≥15 points for subjects with CD from baseline of the parent study and with total PCDAI ≤
- •A male subject who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (eg, condom with or without spermicide) from signing of subject/ parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male subject should also be advised to use a highly effective method of contraception.
- •A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of subject/parental informed consent and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose.
- •Main Criteria for Inclusion in the Observational Cohort: The subject, parent, or legal guardian signs and dates a written, informed consent form.
- •The subject has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort of this study.
排除标准
- •Treatment Cohort only: The subject is female and is lactating or pregnant.
- •The subject has hypersensitivity or allergies to vedolizumab or any of its excipients.
- •The subject currently requires major surgical intervention for UC or CD (eg, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
- •The subject has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety.
- •The subject has other serious comorbidities that will limit their ability to complete the study.
- •The subject is unable to comply with all study assessments.
结局指标
主要结局
For the Treatment Cohort: The primary endpoint for this study is the incidence of adverse events (AEs).
For the Treatment Cohort: The primary endpoint for this study is the incidence of adverse events (AEs).
For the Observational Cohort: Incidence of prespecified safety events (serious infections, malignancies, progressive multifocal leukoencephalopathy [PML], concerns about growth and pubertal development, and bowel surgery).
For the Observational Cohort: Incidence of prespecified safety events (serious infections, malignancies, progressive multifocal leukoencephalopathy [PML], concerns about growth and pubertal development, and bowel surgery).
次要结局
- For the Treatment Cohort: • Time to major IBD-related events (eg, hospitalizations, surgeries, or procedures). • Changes from baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III total and subscale scores for subjects aged 9 to 17 years as measured every 24 weeks.
研究者
Director, Clinical Operations
Scientific
Takeda Development Center Americas Inc.
研究点 (23)
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