The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis

Inclusion Criteria: * Age ≥ 18 years old * Established diagnosis of Ulcerative Colitis (UC) * Moderately to severely active left sided UC assessed by central reading * Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of oral 5-ASA/SP use * Current Glucocorticosteroids (GCS) use or history of GCS dependency, refractory, or intolerance * Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents: * Immunomodulators * Tumor Necrosis Factor alpha (TNF-α) inhibitors and/or anti-integrins Exclusion Criteria: * Suspicion of differential diagnosis * Acute fulminant UC and/or signs of systemic toxicity * UC limited to the rectum (disease which extend \<15 cm above the anal verge) * History of malignancy * History or presence of any clinically significant disorder * Concomitant treatment with cyclosporine, methotrexate, tacrolimus, TNF-α inhibitors, anti-integrins or similar immunosuppressants and immunomodulators * Treatment with rectal GCS, 5-ASA/SP or tacrolimus * Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) * Serious active infection * Gastrointestinal infections * Currently receiving parenteral nutrition or blood transfusions * Females who are lactating or have a positive serum pregnancy test * Women of childbearing potential not using reliable contraceptive methods * Concurrent participation in another clinical study * Previous exposure to cobitolimod