A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Upadacitinib; Placebo for Upadacitinib
Intervention description: Oral; Tablet; Oral; Tablet
Intervention MeSH terms: Upadacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 526.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Upadacitinib; ABT-494; Efficacy; Safety; Crohn's Disease

Summary:

      The objective of this study is to evaluate the efficacy and safety of upadacitinib compared
      to placebo as induction therapy in adults with moderately and severely active Crohn's disease
      (CD).
    

Eligibility criteria:

        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 (oral locally acting steroids, intravenous or oral corticosteroids,
             immunosuppressants or biologic therapies for CD), in the opinion of the investigator.

               -  Note: Participants who have had inadequate response or intolerance to
                  conventional therapy who have received prior biologic 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, participant must meet the contraception recommendations.

        Exclusion Criteria:

          -  Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

          -  Participant not on stable doses of CD related antibiotics, oral aminosalicylates,
             corticosteroids or methotrexate (MTX).

          -  Participant with the following ongoing known complications of CD: abscess (abdominal
             or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, > 2
             entire missing segments of the following 5 segments: terminal ileum, right colon,
             transverse colon, sigmoid and left colon, and rectum, or any other manifestation that
             might require surgery while enrolled in the study.

          -  Participant with ostomy or ileoanal pouch.

          -  Participant diagnosed with conditions that could interfere with drug absorption
             including but not limited to short gut or short bowel syndrome.

          -  Screening laboratory and other analyses show abnormal results.