A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Moderate to Severe Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieved Clinical Remission at Week 6
研究概览
简要总结
The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is being given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6 months prior to initiating study drug
- •Moderately to severely active Crohn's disease, as defined by a CDAI score >250 and < 450 at baseline
- •Evidence of active inflammation
排除标准
- •Short bowel syndrome
- •Stricture with obstructive symptoms within 3 months
- •Bowel surgery within 3 months
- •Ileostomy and/or colostomy
- •Any gastric or intestinal pouch
- •Ulcerative colitis
- •Evidence of an infected abscess
- •Bowel perforation or evidence of noninflammatory obstruction during the 6 months
- •Stool positive for C. Difficile toxin at screening
- •Presence of active infection requiring treatment
- •Serious infection within 8 weeks
- •Significant concurrent medical conditions
- •Pregnant or breast feeding
- •Significant Laboratory abnormalities
- •Any anti-tumor necrosis factor (TNF) agent within 2 months
- •Steroid enemas within 2 weeks
- •Tysabri (natalizumab) within 1 year
- •Biologic agents (eg, ustekinumab), experimental procedures, or live vaccines within 3 months
- •Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),thalidomide or tacrolimus within 2 months
研究组 & 干预措施
Placebo
Participants received placebo intravenously at baseline and week 4.
干预措施: Placebo (Drug)
Brodalumab 210 mg
Participants received 210 mg brodalumab intravenously at baseline and week 4.
干预措施: Brodalumab (Biological)
Brodalumab 350 mg
Participants received 350 mg brodalumab intravenously at baseline and week 4.
干预措施: Brodalumab (Biological)
Brodalumab 700 mg
Participants received 700 mg brodalumab intravenously at baseline and week 4.
干预措施: Brodalumab (Biological)
结局指标
主要结局
Percentage of Participants Who Achieved Clinical Remission at Week 6
时间窗: Week 6
Clinical remission is defined by a CDAI score of ≤ 150 points. 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 or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.
次要结局
- Percentage of Participants Who Achieved a CDAI Response at Week 6(Week 6)
- Time to Maximum Observed Concentration (Tmax) of Brodalumab(After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85.)
- Change From Baseline in CDAI at Week 6(Baseline and week 6)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(From first dose of study drug up to week 12.)
- Maximum Observed Concentration (Cmax) of Brodalumab(After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85.)
- Area Under the Serum Concentration Versus Time Curve, From Time Zero to the Last Measurable Concentration (AUClast) for Brodalumab(After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, 57, 64-66, and 85.)
- Area Under the Serum Concentration Versus Time Curve From Time Zero to 28 Days (AUC0-28) for Brodalumab(After first dose on Day 1 (pre-dose and within 15 minutes after the end of infusion [EOI]), day 4-6, 15, and 29 (pre-dose) and after second dose on day 29 (pre-dose and within 15 minutes after EOI), days 32-34, 43, and 57.)