U-ENDURE
Brief summary
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.
Interventional study
- 1
- 2
- 3
- 4
Age:
From 18 Years to 75 Years.
Inclusion Criteria:
For Substudy 1:
- Participant who achieve clinical response in Study M14-431 or Study M14-433.
- 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 achieved clinical response at the time described in the protocol and
completes study procedures in the parent study/ substudy.
Exclusion Criteria:
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).
