A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 69
- 主要终点
- Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission
研究概览
简要总结
The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants from originating studies (I6T-MC-AMBA [NCT05784246], I6T-MC-AMBU [NCT04004611], I6T-MC-AMAM [NCT03926130]) , I6T-MC-AMAY [NCT05509777]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab
- •Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
- •Female participants must agree to contraception requirements.
排除标准
- •Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.
- •Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.
- •Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.
- •Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.
- •Participants must not have adenomatous polyps that have not been removed.
- •Participants must not be pregnant or breastfeeding.
研究组 & 干预措施
Mirikizumab Dose 4 for CD
Dose 4 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
干预措施: Mirikizumab (Drug)
Mirikizumab Dose 3 for UC
Dose 3 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
干预措施: Mirikizumab (Drug)
Mirikizumab Dose 2 for UC
Dose 2 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
干预措施: Mirikizumab (Drug)
Mirikizumab Dose 5 for CD
Dose 5 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
干预措施: Mirikizumab (Drug)
Mirikizumab Dose 6 for CD
Dose 6 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
干预措施: Mirikizumab (Drug)
Mirikizumab Dose 1 for UC
Dose 1 of Mirikizumab is administered subcutaneously (SC)
Dosing is based on the participant's weight.
干预措施: Mirikizumab (Drug)
Mirikizumab Dose 7 for UC or CD
Intravenous (IV) rescue dosing, if response is lost.
干预措施: Mirikizumab (Drug)
结局指标
主要结局
Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission
时间窗: Week 52
Clinical Remission based on the MMS
Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
时间窗: Week 52
Clinical Remission based on the PCDAI
次要结局
- Percentage of Participants with UC in MMS Clinical Response(Week 52)
- Percentage of Participants with CD in PCDAI Clinical Response(Week 52)
- Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response(Week 52)
- Percentage of Participants with UC in PUCAI Clinical Remission(Week 52)
- Percentage of Participants with UC in Endoscopic Remission(Week 52)
- Percentage of Participants with CD in Endoscopic Remission(Week 52)
- Percentage of Participants with UC in Endoscopic Response(Week 52)
- Percentage of Participants with CD in Endoscopic Response(Week 52)
- Percentage of Participants with UC in having Endoscopic Subscore = 0(Week 52)
- Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission(Week 52)
- Percentage of Participants with CD Achieving Histologic Remission(Week 52)
- Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery(Week 52)
- Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery(Week 52)
- Time to First Dose of Corticosteroid Among Participants with UC Entering Study AMAZ Not on Corticosteroids(Week 0 to Week 52)
- Percentage of Participants Who Achieve both Clinical Remission by PCDAI and Endoscopic Response(Week 52)
- Change from Baseline Over Time in C-reactive Protein, High Sensitivity (hsCRP)(Baseline, Week 0 to Week 52)