A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 94
- 主要终点
- Percentage of Participants Achieving Endoscopic Remission at Month 12
研究概览
简要总结
This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must have completed Study M13-740 through Week
- •If female, participant must be postmenopausal, surgically sterile or on using a birth control method.
排除标准
- •For any reason participant is considered by the investigator to be an unsuitable candidate
- •Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.
- •Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.
研究组 & 干预措施
Upadacitinib (ABT-494) Dose A
Open label dose A once daily (QD)
干预措施: ABT-494 (Drug)
Upadacitinib (ABT-494) Dose B
Open label dose B QD
干预措施: ABT-494 (Drug)
结局指标
主要结局
Percentage of Participants Achieving Endoscopic Remission at Month 12
时间窗: Month 12
Endoscopic remission was based on Simplified Endoscopic Score for Crohn's disease (SES-CD). The SES-CD assessed the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. SES-CD was based on endoscopic findings in 5 bowel segments (Ileum, right colon, transverse colon, left colon/sigmoid, and rectum). Each item was scored 0 to 3 per segment. The sum of the scores for each endoscopic variable ranged from 0 to 15, except for stenosis, where it varied between 0 and 11; total score ranged from 0 to 56. A lower score indicated better outcome. Endoscopic remission was defined as SES-CD ≤4 and at least two-point reduction versus Baseline of Study M13-740 and no subscore \>1 in any individual variable.
Percentage of Participants Achieving Clinical Remission at Month 12
时间窗: Month 12
Clinical remission was defined as average daily stool frequency ≤1.5 and not worse than Baseline and average daily abdominal pain score ≤1.0 and not worse than baseline in Study M13-740. Abdominal pain was assessed using the CDAI component "abdominal pain" rated as none \[0\], mild \[1\], moderate \[2\], and severe \[3\]) (cumulative total over the past 7 days) as per the CDAI to calculate abdominal pain score; total score range from 0 to 105.
次要结局
- Percentage of Participants Achieving Endoscopic Remission(Week 0 (Baseline), Months 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Achieving Clinical Remission(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Achieving Modified Clinical Remission(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Achieving Remission(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Achieving CDAI Remission(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants in Endoscopic Remission at Week 0 Who Maintained Endoscopic Remission(Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Achieving Endoscopic Improvement(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free at the Specified Timepoint in Study M14-327(Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Achieving Remission and Normal C-Reactive Protein (CRP)(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants in Remission at Week 0 Who Maintained Remission(Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Achieving Response(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Achieving Enhanced Clinical Response(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Achieving Clinical Response(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Achieving CDAI Response(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Achieving Enhanced CDAI Response(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Achieving Endoscopic Response(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Achieving IBDQ Response(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission(Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Change From Baseline in Fecal Calprotectin Levels(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Change From Baseline in Hs-CRP Levels(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Change From Baseline in IBDQ Total Score(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)
- Change From Baseline in SES-CD(Week 0 (Baseline), Months 12, 24, 36, 48, 60, 72, 84, and 96)