A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis (UC)
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Placebo; Upadacitinib
Intervention description: Tablet for oral administration; Tablet for oral administration
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: 522.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Upadacitinib; ABT-494; Ulcerative Colitis

Summary:

      The objective of this study is to evaluate the efficacy and safety of upadacitinib compared
      to placebo in inducing clinical remission (per Adapted Mayo score) in participants with
      moderately to severely active ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

        - Male or female participants ≥ 16 and ≤ 75 years of age at Baseline Note: Adolescent
        participants at the age of 16 or 17 years old will be eligible to participate if approved
        by the country or regulatory/health authorities.

        Note: Adolescent participants at the age of 16 or 17 years old must weigh ≥ 40 kilograms
        and meet the definition of Tanner Stage 5 at the Screening Visit.

          -  Diagnosis of Ulcerative Colitis (UC) for 90 days or greater prior to Baseline,
             confirmed by colonoscopy during the Screening Period, with exclusion of current
             infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy
             results consistent with the diagnosis of UC, in the assessment of the Investigator,
             must be available.

          -  Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to
             3.

          -  Demonstrated an inadequate response, loss of response, or intolerance to at lease one
             of the following treatments including, oral aminosalicylates, corticosteroids,
             immunosuppressants, and/or biologic therapies.

        Note: Participants who have had inadequate response, loss of response to conventional
        therapy but have not failed biologic therapy (Non-bio-IR) and have received a prior
        biologic for up to 1 year may be enrolled, however they must have discontinued the biologic
        for reasons other than inadequate response or intolerance (e.g., change of insurance, well
        controlled disease), and must meet criteria for inadequate response, loss of response, or
        intolerance as defined above.

          -  Female Participants of childbearing potential must have a negative serum pregnancy
             test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit.

          -  If female, participant must meet the contraception recommendation criteria.

        Exclusion Criteria:

          -  Participant with current diagnosis of Crohn's disease (CD) or diagnosis of
             indeterminate colitis (IC).

          -  Current diagnosis of fulminant colitis and/or toxic megacolon.

          -  Participant with disease limited to the rectum (ulcerative proctitis) during the
             Screening endoscopy.

          -  Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30
             days prior to Baseline.

          -  Participant who received azathioprine or 6-mercaptopurine (6-MP) within 10 days of
             Baseline.

          -  Received intravenous corticosteroids within 14 days prior to Screening or during the
             Screening Period.

          -  Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g.,
             tofacitinib, baricitinib, filgotinib, upadacitinib).

          -  Screening laboratory and other analyses show any prespecified abnormal hematologic
             results.