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
- 进行中（未招募）
- 发起方
- 入组人数
- 747
- 试验地点
- 931
- 主要终点
- Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)
研究概览
简要总结
A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •For Substudy 1:
- •Participant who achieve clinical response in Study M14-431 or Study M14-
- •Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
- •For Substudy 2:
- •Participant completes Substudy
- •The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
- •Participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.
排除标准
- •For Substudies 1 and 2:
- •Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- •Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study.
- •Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants 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.
- •Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of Study M14-430 (Week 52).
研究组 & 干预措施
Substudy 1: Cohort 1 Upadacitinib Dose A
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose A for 52 weeks.
干预措施: Upadacitinib (Drug)
Substudy 1: Cohort 1 Upadacitinib Dose B
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose B for 52 weeks.
干预措施: Upadacitinib (Drug)
Substudy 1: Cohort 1 Placebo
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive placebo for 52 weeks.
干预措施: Placebo for Upadacitinib (Drug)
Substudy 1: Cohort 2 Placebo
This is a maintenance group which includes participants who received double-blind placebo in studies M14-431 and M14-433 and achieved clinical response will continue to receive blinded placebo for 52 Weeks.
干预措施: Placebo for Upadacitinib (Drug)
Substudy 2: Cohort 5 Placebo
This is a long-term extension group which includes participants who complete Substudy 1 and will receive placebo for 240 weeks.
干预措施: Placebo for Upadacitinib (Drug)
Substudy 2: Cohort 5 Upadacitinib Dose B
This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose B for 240 weeks.
干预措施: Upadacitinib (Drug)
Substudy 1: Cohort 3 Upadacitinib Dose B
This is a maintenance group which includes participants who achieved clinical response to upadacitinib from the extended treatment period of studies M14-431 and M14-433 and will receive upadacitinib Dose B for 52 Weeks.
干预措施: Upadacitinib (Drug)
Substudy 2: Cohort 4 Upadacitinib Dose B
This is a long-term extension group which includes participants who achieved clinical response in the open-label extended treatment period of study M14-431 and will receive upadacitinib dose B for 240 weeks.
干预措施: Upadacitinib (Drug)
Substudy 2: Cohort 5 Upadacitinib Dose A
This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose A for 240 weeks.
干预措施: Upadacitinib (Drug)
结局指标
主要结局
Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)
时间窗: Week 52
Clinical remission per CDAI is defined as CDAI \<150.
Sub-Study 1: Percentage of Participants with Endoscopic Response
时间窗: Week 52
Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.
Number of Participants with Adverse Events
时间窗: Through Week 240
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.
次要结局
- Sub-Study 1: Percentage of Participants with Endoscopic Remission(Week 52)
- Sub-Study 1: Percentage of Participants without Corticosteroid use for Crohn's Disease Among All Participants(Week 52)
- Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission(Week 52)
- Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI(Through Week 52)
- Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs)(Week 52)
- Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)(Week 52)
- Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use for Crohn's Disease at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline.(Week 52)
- Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)(Baseline (Week 0) to Week 52)
- Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)(Baseline (Week 0) to Week 52)
- Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD)(Up to Week 52)
- Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline(Week 52)