2023-508804-39-00招募中3 期
A Phase 3b Extension Study to Evaluate the Long-Term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 26
- 主要终点
- Observational Cohort: Incidence of safety events (SAEs, serious infections, malignancies, PML, bowel surgery, and delay in growth or pubertal development).
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 SC treatment in pediatric subjects with UC or CD
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Observational Cohort
- 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 caregiver signs and dates a written treatment cohort subject/parental 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 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 completed Week 34 of Study VedolizumabSC-3003 and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for subjects with UC is defined as a reduction of partial Mayo score of ≥2 points and ≥25% from baseline (from VedolizumabSC-3003), including a ≥1-point decrease in the Mayo stool frequency subscore and a ≥1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of ≤1 point. Clinical response for subjects with CD is defined as a PCDAI ≤30 with a reduction in the PCDAI of ≥15 points from baseline (from VedolizumabSC-3003)
- •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 spermicide) from signing of subject/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after the 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 non-sterilized 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 for 18 weeks after the last dose
- •Observational Cohort:
- •The subject, subject’s legally authorized representative or adult caregiver signs and dates a written observational cohort subject/parental informed consent and/or pediatric assent form and any required privacy authorization before the initiation of any study procedures, as required per local regulations.
- •Observational Cohort:
- •The subject has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 but was not eligible to enroll in the treatment cohort of this study
排除标准
- •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 developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, GI, 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
Observational Cohort: Incidence of safety events (SAEs, serious infections, malignancies, PML, bowel surgery, and delay in growth or pubertal development).
Observational Cohort: Incidence of safety events (SAEs, serious infections, malignancies, PML, bowel surgery, and delay in growth or pubertal development).
Treatment Cohort: The primary endpoints for this study are the incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (ie, infections including opportunistic infection, such as PML; liver injury; malignancies; injection-related reactions or systemic reactions including anaphylaxis and hypersensitivity reactions)
Treatment Cohort: The primary endpoints for this study are the incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (ie, infections including opportunistic infection, such as PML; liver injury; malignancies; injection-related reactions or systemic reactions including anaphylaxis and hypersensitivity reactions)
次要结局
- Treatment Cohort: Time to major IBD-related events (eg, hospitalizations, surgeries, or procedures) from Day 1 of Study VedolizumabSC-3004.
- Changes from baseline of Study VedolizumabSC-3003 in IMPACT-III total and subscale scores for subjects aged 9 to 17 years
研究者
Ninfa Candela MD
Scientific
Takeda Development Center Americas Inc.
研究点 (26)
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