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

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 738 人开始时间: 2018年2月27日最近更新: 2024年2月26日

研究概览

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•For Substudy 1:
•- Participant who receive double-blind treatment in Study M14- 431 or Study M14-433 and achieve clinical response.
•- Participant completes Week 12 or Week 24 study procedures
•For Substudy 2:
•- Participant completes Substudy 2
•- Participant who receive open-label upadacitinib Dose B in Study M14-431 and achieve clinical response.
•- Participant completes study procedures in the parent study/substudy.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 731
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 37

•For Sub-studies 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 Study M14-431 or Substudy 1 of Study M14-430 that in the investigator's judgment makes the subject unsuitable for this study.
•- Participant with any active or chronic recurring infections based on the investigator's assessment that makes the subject an unsuitable candidate for the study. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is cured, based on the investigator's assessment.
•- Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Study M14-431 (Week 24) or Substudy 1 of Study M14-430 (Week 40).

发起方