A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis

Inclusion Criteria:

• Diagnosis of ulcerative colitis for at least 3 months from the time of initial diagnosis. The diagnosis must have been confirmed by historical endoscopy and histology. The severity of disease must have been confirmed by endoscopy at screening
• Currently receiving oral aminosalicylates at approved doses for at least 6 weeks of at least 2g/day. Doses of oral aminosalicylates should be stable for at least two weeks prior to dosing (Visit 2)

Exclusion Criteria:

• Diagnosis of UC limited to the rectum (ulcerative proctitis only, defined as 15 cm from the anal verge)
• Requiring hospitalisation for current episode of severe UC
• Use of biologic therapies for the treatment of UC within 12 weeks prior to dosing (Visit 2)
• Treatment failures to anti-tumour necrosis factor-alfa (anti-TNF-a) agents (e.g. infliximab, adalimumab)
• Use of immunosuppressant agents (e.g. azathioprine) within 4 weeks prior to dosing (Visit 2)
• Use of corticosteroids (oral, intravenous (i.v.), intramuscular (i.m.), or rectal ) within 14 days prior to dosing (Visit 2)
• Use of enemas (corticosteroid or aminosalicylate) within 14 days prior to screening (Visit 1)
• Use of cyclosporine, tacrolimus, D-penicillamine, leflunomide, methotrexate, mycophenolate mofetil, or thalidomide within 4 weeks prior to dosing (Visit 2)
• Currently receiving total parenteral nutrition