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

Prior treatment

• Have failed treatment with more than three advanced therapies of two different therapeutic classes.
• Have had surgery for treatment of UC.
• Concomitant treatment with cyclosporine, methotrexate, tacrolimus, or advanced therapies or similar immunosuppressants and immunomodulators.
• Treatment with rectal GCS, 5-ASA/SP or tacrolimus.
• Concurrent participation in another clinical study.
• Previous exposure to cobitolimod.

Other illness

• History or presence of any clinically significant disorder.
• Serious known active infection including history of latent or active tuberculosis.
• Gastrointestinal infections including positive Clostridium difficile stool assay.

Lab values

• Females who are lactating or have a positive serum pregnancy test.

Age

• History of malignancy, unless treated with no relapse of the disease and ≥ 5 years since last treatment (cured).

Other

• Suspicion of differential diagnosis.
• Acute fulminant UC and/or signs of systemic toxicity.
• UC limited to the rectum or extending beyond the splenic flexure.
• Long-term treatment (>14 days) with antibiotics or NSAIDs .
• Women of childbearing potential not using highly effective contraceptive methods.
• Participants will not be eligible for the maintenance study if they are not willing to comply with all further study requirements.

• Male or female ≥ 18 years of age.
• Established diagnosis of UC.
• Moderate to severe active left-sided UC assessed by central reading.
• Have inadequate response, loss of response or be intolerant of at least one of the following treatments: Oral GCS, AZA/6-MP, Biologics, JAK-inhibitors, or other approved advanced therapies for UC.
• Allowed to receive a therapeutic dose of the following UC drugs during the study: Oral GCS therapy (≤20 mg prednisone or equivalent/day) , Oral 5-ASA/SP compounds, AZA/6-MP.
• Ability to understand the treatment, willingness to comply with all study requirements, and ability to provide informed consent.
• Participants are eligible to be included in the maintenance study if they have achieved clinical response at week 6 and have adhered to the protocol procedures of the induction study.