A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of an active drug, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.
From 18 Years to 75 Years.
For Substudy 1:
- Participant who receive double-blind treatment in Study M14-431 or Study M14-433 and
achieve clinical response.
- 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 1. The Week 52 endoscopy may be missing, if the
endoscopy cannot be performed during the COVID-19 pandemic.
- Participant who receive open-label upadacitinib Dose B in Study M14-431 and achieve
- Participant completes study procedures in the parent study/substudy.
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 Studies M14-431 and M14-433 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 Studies M14-431, M14-433 or Substudy 1 of
Study M14-430 (Week 52).