A Multicenter, Randomized, Double-Blind, Placebo Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease Who Completed the Studies M14-431 or M14-433
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 229
- 试验地点
- 71
- 主要终点
- Sub-study 1 Cohort 1 (Upadacitinib vs Placebo): Proportion of subjects with clinical remission per PROs at Week 52
研究概览
简要总结
Sub-study 1 (randomized, double-blind, placebo-controlled maintenance): To evaluate the efficacy and safety of two doses of upadacitinib versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to upadacitinib induction treatment in Studies M14-431 or M14-433.
Sub-study 2 (long-term extension [LTE]): To evaluate safety and efficacy of long-term administration of upadacitinib in subjects with moderately to severely active CD who participated in the Phase 3 upadacitinib induction and maintenance studies.
研究设计
- 分配方式
- Randomized
- 主要目的
- Sub-study 2
- 盲法
- Double (Monitor, Subject, Analyst, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Sub-study 1: Subject who receive double-blind treatment in Study M14- 431 or Study M14-433 and achieve clinical response.
- •Sub-study 1: Subject completes Week 12 or Week 24 study procedures in study M14431 or study M14-
- •The final endoscopy for studies M14-431 or M14433 may be missing, if the endoscopy cannot be performed during the coronavirus SARS-CoV-2 pandemic.
- •Sub-study 2: Subject completes Substudy 1 of Study M14-
- •The week 52 endoscopy may be missing, if the endoscopy cannot be performed during the coronavirus SARS-CoV-2 pandemic.
- •Sub-study 2: Subject achieved clinical response at Week 24 and completed Week 24 visit and procedures in Part 3/Cohort 3 of Study M14-431.
排除标准
- •Sub-study 1 and 2: Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
- •Sub-study 1 and 2: Subject who has a known hypersensitivity to upadacitinib or its excipients, or had an AE during Studies M14-431, M14-433, or Sub-study 1 or 2 of Study M14-430 that, in the investigator's judgment, makes the subject unsuitable for this study
- •Sub-study 1 and 2: Subjects who anticipate the need for any live vaccine during study participation including at least 30 days (or longer, if required locally after the last dose of study drug
- •Sub-study 1 and 2: Subject at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment makes the subject an unsuitable candidate for the study. Subjects with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed, and the infection is resolved, based on the investigator's assessment
- •Sub-study 1 and 2: Subjects with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433, or Sub-study 1 or 2 of Study M14-430
结局指标
主要结局
Sub-study 1 Cohort 1 (Upadacitinib vs Placebo): Proportion of subjects with clinical remission per PROs at Week 52
Sub-study 1 Cohort 1 (Upadacitinib vs Placebo): Proportion of subjects with clinical remission per PROs at Week 52
Sub-study 1 Cohort 1 (Upadacitinib vs Placebo): Proportion of subjects with endoscopic response at Week 52
Sub-study 1 Cohort 1 (Upadacitinib vs Placebo): Proportion of subjects with endoscopic response at Week 52
Sub-study 2: Occurrence rate of subjects with total hospitalizations (all-cause) over time with CD-related hospitalizations over time with surgeries over time with CD-related surgeries over time
Sub-study 2: Occurrence rate of subjects with total hospitalizations (all-cause) over time with CD-related hospitalizations over time with surgeries over time with CD-related surgeries over time
次要结局
- Sub-study 1: Proportion of subjects with clinical remission per CDAI at Week 52
- Sub-study 1: Proportion of subjects with endoscopic remission at Week 52
- Sub-study 1: Change from Baseline in IBDQ at Week 52
- Sub-study 1: Proportion of subjects achieving CR-100 at Week 52
- Sub-study 1: Proportion of subjects without corticosteroid use for CD at least 90 days prior to Week 52 and achieved clinical remission per PROs at Week 52 (among all subjects)
- Sub-study 1: Proportion of subjects who discontinued corticosteroid use for CD at least 90 days prior to Week 52 and achieved clinical remission per PROs at Week 52 in subjects taking corticosteroids for CD at Baseline of induction
- Sub-study 1: Proportion of subjects with clinical remission per PROs at Week 0 and Week 52
- Sub-study 1: Change from Baseline in FACIT-F at Week 52
- Sub-study 1: Proportion of subjects with clinical remission per PROs and endoscopic remission at Week 52
- Sub-study 1: Proportion of subjects with CD-related hospitalizations during the 52 Week double-blind maintenance period
- Sub-study 1: Proportion of subjects with resolution of EIMs at Week 52, in subjects with EIMs at Baseline
- Sub-study 2: Proportion of subjects with clinical remission over time
- Sub-study 2: Proportion of subjects with enhanced clinical response over time
- Sub-study 2: Proportion of subjects with clinical response over time
- Sub-study 2: Proportion of subjects with CR-100 over time
- Sub-study 2: Proportion of subjects with endoscopic remission at Week 0, and every 48 weeks thereafter
- Sub-study 2: Proportion of subjects with endoscopic response at Week 0, and every 48 weeks thereafter
- Sub-study 2: Proportion of subjects without corticosteroid use for CD and achieve clinical remission over time
- Sub-study 2: Time loss of enhanced clinical response
- Sub-study 2: Time loss of clinical remission
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG