A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 996
- 试验地点
- 620
- 主要终点
- Percentage of Participants Achieving Endoscopic Response at Week 52 (Participants Originating From AMAM Study)
研究概览
简要总结
The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
- •If female, participant must meet the contraception requirements
排除标准
- •Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial.
- •Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study.
- •Note: Participants with a history of active TB with documentation of treatment by the Centers for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior to the originator study are not excluded from the study.
- •Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.
- •Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.
研究组 & 干预措施
AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC
Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
干预措施: Mirikizumab (Drug)
AMAM Miri: Miri 900 mg IV Then 300 mg SC
Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg intravenously (IV) Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
干预措施: Mirikizumab (Drug)
AMAM Uste: Miri 900 mg IV Then 300 mg SC
Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
干预措施: Mirikizumab (Drug)
AMAM Mirikizumab (Miri): Miri 300 mg SC
Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) for 52 weeks.
干预措施: Mirikizumab (Drug)
AMAM PBO: Miri 300 mg SC
Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.
干预措施: Mirikizumab (Drug)
AMAM Ustekinumab (Uste): Miri 300 mg SC
Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.
干预措施: Mirikizumab (Drug)
AMAM PBO: Miri 900 mg IV Then 300 mg SC
Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
干预措施: Mirikizumab (Drug)
AMAM Placebo (PBO)/Miri: Miri 300 mg SC
Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.
干预措施: Mirikizumab (Drug)
All AMAG Participants: Miri 300 mg SC
Participants from Study AMAG who continued into Study AMAX received mirikizumab 300 mg SC Q4W for 52 weeks.
干预措施: Mirikizumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving Endoscopic Response at Week 52 (Participants Originating From AMAM Study)
时间窗: Week 52
Endoscopic Response defined as ≥50% reduction from AMAM study baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) total score. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 individual assessments. Total SES-CD score is the sum of all 20 individual assessment scores across all the bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.
Percentage of Participants Achieving Clinical Remission at Week 52 (Participants Originating From AMAM Study)
时间窗: Week 52
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) total score \< (less than) 150. The CDAI measures the severity of active disease using 8 disease variables: stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations, presence or absence of fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight. Each variable is assigned a specific weight/multiplier, and the weighted values are summed to produce a CDAI total score. CDAI total scores can range from 0 to 600, with higher scores indicating more severe disease.
Percentage of Participants Achieving Endoscopic Response at Week 52 (Participants Originating From AMAM Study)
时间窗: Week 52
Endoscopic Response defined as ≥50% reduction from AMAM study baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) total score. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 individual assessments. Total SES-CD score is the sum of all 20 individual assessment scores across all the bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.
Percentage of Participants Achieving Clinical Remission at Week 52 (Participants Originating From AMAM Study)
时间窗: Week 52
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) total score \< (less than) 150. The CDAI measures the severity of active disease using 8 disease variables: stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations, presence or absence of fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight. Each variable is assigned a specific weight/multiplier, and the weighted values are summed to produce a CDAI total score. CDAI total scores can range from 0 to 600, with higher scores indicating more severe disease.
次要结局
- Percentage of Participants Achieving Alternate Endoscopic Remission at Week 52 (Participants Originating From AMAM Study)(Week 52)
- Percentage of Participants Achieving Clinical Response by Patient Reported Outcome (PRO) at Week 52 - (Participants Originating From AMAM Study)(Week 52)
- Fecal Calprotectin at Week 12 (Participants Originating From AMAM Study)(Week 12)
- C-Reactive Protein (CRP) at Week 12 (Participants Originating From AMAM Study)(Week 12)
- Change From Baseline in Health Related Quality of Life at Week 52 : Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Participants Originating From AMAM Study)(Baseline, Week 52)
- Percentage of Participants Achieving Alternate Endoscopic Remission at Week 52 (Participants Originating From AMAM Study)(Week 52)
- Percentage of Participants Achieving Clinical Response by Patient Reported Outcome (PRO) at Week 52 - (Participants Originating From AMAM Study)(Week 52)
- Fecal Calprotectin at Week 12 (Participants Originating From AMAM Study)(Week 12)
- C-Reactive Protein (CRP) at Week 12 (Participants Originating From AMAM Study)(Week 12)
- Change From Baseline in Health Related Quality of Life at Week 52 : Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Participants Originating From AMAM Study)(Baseline, Week 52)