
    sponsor decision
  
['ulcerative colitis']
['ged-0507-34-levo 80 mg', 'ged-0507-34-levo 160 mg', 'placebo']

        Inclusion Criteria:

          -  Male or female aged 18 and over at the time of signing the informed consent.

          -  Diagnosis of UC with a duration of at least 3 months prior to the Screening Visit.

          -  MMS ≥ 4 to ≤ 8 (range: 0 - 9) prior to randomization in the study

          -  Subjects are required to have a colonoscopy if one has not been performed within 12
             months prior to the Screening Visit.

          -  Subjects who have relapsed on maintenance therapy with doses of 5-ASA ≤ 2.4 g/day

        Exclusion Criteria:

          -  Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic
             colitis, radiation colitis, or diverticular disease-associated colitis.

          -  UC restricted to the distal 15 cm or less (eg, ulcerative proctitis).

          -  Subjects who have had surgery as a treatment for UC or who, in the opinion of the
             Investigator, are likely to require surgery for UC during the study.

          -  Clinical signs suggestive of fulminant colitis or toxic megacolon.

          -  Evidence of pathogenic enteric infection.

          -  History of colorectal cancer or colorectal dysplasia.

          -  Prior use of any TNF inhibitor (or any biologic agent).

          -  Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, or thalidomide.

          -  Use of budesonide-MMx within the last 8 weeks.

          -  Use of oral and/or IV corticosteroids within 2 weeks of the Screening Visit.

          -  Use of immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP] or methotrexate
             [MTX]) within 8 weeks of the Screening Visit.
      