The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

Exclusion Criteria

• •Suspicion of differential diagnosis.
• •Acute fulminant UC and/or signs of systemic toxicity.
• •UC limited to the rectum or extending beyond the splenic flexure.
• •Have failed treatment with more than three advanced therapies of two different therapeutic classes.
• •Have had surgery for treatment of UC.
• •History of malignancy, unless treated with no relapse of the disease and ≥ 5 years since last treatment (cured).
• •History or presence of any clinically significant disorder.
• •Concomitant treatment with cyclosporine, methotrexate, tacrolimus, or advanced therapies or similar immunosuppressants and immunomodulators.
• •Treatment with rectal GCS, 5-ASA/SP or tacrolimus.
• •Long-term treatment (\>14 days) with antibiotics or NSAIDs .
• •Serious known active infection including history of latent or active tuberculosis.
• •Gastrointestinal infections including positive Clostridium difficile stool assay.
• •Females who are lactating or have a positive serum pregnancy test.
• •Women of childbearing potential not using highly effective contraceptive methods.
• •Concurrent participation in another clinical study.
• •Previous exposure to cobitolimod.
• •Participants will not be eligible for the maintenance study if they are not willing to comply with all further study requirements.