A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

Inclusion Criteria:

• Male or female participants ≥ 16 and ≤ 75 years of age at Baseline Note: Adolescentparticipants at the age of 16 or 17 years old will be eligible to participate if approvedby the country or regulatory/health authorities. Note: Adolescent participants at the age of 16 or 17 years old must weigh ≥ 40 kilogramsand 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 currentinfection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsyresults 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

• Demonstrated an inadequate response, loss of response, or intolerance to at lease oneof the following treatments including, oral aminosalicylates, corticosteroids,immunosuppressants, and/or biologic therapies. Note: Participants who have had inadequate response, loss of response to conventionaltherapy but have not failed biologic therapy (Non-bio-IR) and have received a priorbiologic for up to 1 year may be enrolled, however they must have discontinued the biologicfor reasons other than inadequate response or intolerance (e.g., change of insurance, wellcontrolled disease), and must meet criteria for inadequate response, loss of response, orintolerance as defined above.
• Female Participants of childbearing potential must have a negative serum pregnancytest 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 ofindeterminate colitis (IC).
• Current diagnosis of fulminant colitis and/or toxic megacolon.
• Participant with disease limited to the rectum (ulcerative proctitis) during theScreening endoscopy.
• Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30days prior to Baseline.
• Participant who received azathioprine or 6-mercaptopurine (6-MP) within 10 days ofBaseline.
• Received intravenous corticosteroids within 14 days prior to Screening or during theScreening 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 hematologicresults.