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 - M14-430

AbbVie B.V.0 个研究点目标入组 29 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•For Substudy 1:
•- Subject achieved clinical response in Study M14-431 or Study M14-433.
•- Subject completed Week 12 (in subjects who achieve response at Week 12) or
•Week 24 (in subjects who achieve response at Week 24) visit and procedures in
•Study M14-431 or Study M14-433. The final endoscopy for Studies M14-431 or
•M14-433 may be missing, if the endoscopy cannot be performed during the
•COVID-19 pandemic.
•Note: Subjects completing Part 3/Cohort 3 of Study M14-431, who received
•open-label Extended Treatment, should enroll in Substudy 2.
•For Substudy 2:
•- Subject completed Week 52 of the maintenance period of Study M14-430
•(Substudy 1).Completion includes the Week 52 endoscopy of Substudy 1. The Week
•52 endoscopy may be missing, if the endoscopy cannot be performed during the
•COVID-19 pandemic or any state of emergency or pandemic situation.
•- Subject achieved clinical response at Week 24 and completed Week 24 visit and
•procedures in Part 3/Cohort 3 of Study M14-431.

•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 or 2 of
•Study M14-430 that in the investigator's judgment makes the subject 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 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, M14-433, or Substudy 1
•or 2 of Study M14-430 (Week 52).

发起方