A Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 37
- 主要终点
- Pharmacokinetics (PK): Clearance of Mirikizumab
研究概览
简要总结
This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab. The study lasted about 52 weeks and included up to 18 visits.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants weighing >10 kg
- •Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications
- •Participants must have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment
- •Participants must have evidence of UC extending proximal to the rectum
- •Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC
排除标准
- •Participants must not have a current diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary sclerosing cholangitis
- •Participants must not have had surgery to remove part of their colon
- •Participants must not have current evidence of toxic megacolon
- •Participants must not have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 1 week of screening endoscopy
- •Participants must not have had an inadequate response to Interleukin-12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)
研究组 & 干预措施
Open Label (OL) Induction Period: 5 milligram per kilogram (mg/kg) Miri intravenous (IV)
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 weeks (Q4W) on weeks 0, 4, 8 for 12 weeks.
干预措施: Mirikizumab (Drug)
Open Label Induction Period: 10 mg/kg Miri IV
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
干预措施: Mirikizumab (Drug)
Open Label Induction Period: 300 mg Miri IV
Participants (>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
干预措施: Mirikizumab (Drug)
Open Label Maintenance Period: 50 mg Miri subcutaneous (SC)
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
干预措施: Mirikizumab (Drug)
Open Label Maintenance Period: 100 mg Miri SC
Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
干预措施: Mirikizumab (Drug)
Open Label Maintenance Period: 200 mg Miri SC
Participants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
干预措施: Mirikizumab (Drug)
Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/ 50 mg Miri SC
Participants (≤40 kg) who were non responders to miri at Week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
干预措施: Mirikizumab (Drug)
Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/100 mg Miri SC
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
干预措施: Mirikizumab (Drug)
Open Label Maintenance Period: Non-Responders: 300 mg Miri IV /200 mg Miri SC
Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
干预措施: Mirikizumab (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Clearance of Mirikizumab
时间窗: Predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8
Clearance of mirikizumab was evaluated. The PK of mirikizumab is characterized at interim analysis points using mixed-effect (population PK) modelling approaches using the available induction and maintenance mirikizumab concentration data.
次要结局
- Percentage of Participants in Clinical Remission(Week 52)
- Percentage of Participants in Clinical Response(Week 52)
- Percentage of Participants Who Are in MMS Clinical Remission Without the Use of Corticosteroids(Week 52)
- Percentage of Participants in Clinical Remission Based on the Pediatric Ulcerative Colitis Activity Index (PUCAI)(Week 52)
- Percentage of Participants in Clinical Response Based on the PUCAI(Week 52)
- Percentage of Participants in Symptomatic Remission(Week 52)
- Height Velocity (in Centimeters/Year)(Week 52)
- Change From Baseline in Body Weight(Baseline, Week 52)
- Percentage of Participants in Endoscopic Remission(Week 52)
- Percentage of Participants With Histologic-Endoscopic Mucosal Remission(Week 52)
- Change From Baseline in 7-day Average of Abdominal Pain Numeric Rating Scale (NRS) Score at Week 12(Baseline, Week 12)
- Change From Baseline in 7-day Average of Abdominal Pain NRS Score at Week 52(Baseline, Week 52)