A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional e/o Biologiche Therapies.

Gender:
Female: yes
Male: yes

Inclusion criteria:
- Confirmed diagnosis of CD for at least 3 months prior to Baseline.
- Confirmed diagnosis of moderate to severe CD as assessed by stool
frequency (SF), abdominal pain (AP) score.
- Evidence of mucosal inflammation based on the Simplified Endoscopic
Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a
central reader.
- Demonstrated an inadequate response or intolerance to one or more
conventional and/or biologic therapies, in the opinion of the
investigator, as defined below:
Oral locally acting steroids
Intravenous or oral corticosteroids
Immunosuppressants
Biologic therapies for CD
Note: Non-bio-IR subjects who have received prior biologic for up to 1
year but have not failed may be enrolled; however, participants must
have discontinued the biologic for reasons other than inadequate
response or intolerance (e.g., change of insurance, well controlled
disease),
- If female, subject must meet the contraception recommendations.
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 476
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion criteria:
-Subject with a current diagnosis of ulcerative colitis or indeterminate
colitis.
- Subject not on stable doses of CD related antibiotics, oral
aminosalicylates, corticosteroids or methotrexate (MTX).
- Subject with the following known complications of CD: abscess
(abdominal or peri-anal), > 2 entire missing segments of the following 5
segments: terminal ileum, right colon, transverse
colon, sigmoid and left colon, and rectum, symptomatic bowel strictures,
fulminant colitis, toxic megacolon, or any other manifestation that might
require surgery while enrolled in the study.
- Subject with ostomy or ileoanal pouch
- Subject diagnosed with short gut or short bowel syndrome
- Screening laboratory and other analyses show abnormal results.