Orismilast for the treatment of moderate to severe ulcerative colitis

Prior treatment

• Any medical or psychiatric condition that, in the Investigator’s opinion, would preclude the patient from adhering to the protocol, completing the study per-protocol, and/or would place the patient at unacceptable risk while receiving the investigational therapy
• Currently treated with biologic therapy
• Currently treated with steroids
• Treated with any therapies and systemic treatments as described in Table 3, “Prohibited Prior Therapies and Treatments” that do not comply with the indicated washout interval
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating
• Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to screening

Other illness

• History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients

Other

• Require hospitalization
• HADS score ≥15 at baseline in the depression subscore
• Clinical signs suggestive of fulminant colitis or toxic megacolon
• Failed on >1 anti-body treatment

• Male or female adult patients, 18 years of age or older. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 that result in a low failure rate of less than 1% per year when used consistently and correctly, for the duration of the trial and 16 weeks after last administration. A list of contraception methods meeting these criteria is provided in the patient information and Appendix E
• Diagnosis of ulcerative colitis with a minimum of 3 months of disease history
• Mayo endoscopic subscore of 2 or 3 at screening
• Current treatment regimen of 5-ASA (e.g., mesalazine and sulfazalazine), mercaptopurine (6-MP), methotrexate (MTX), or azathioprine
• Currently on stable unchanged medication regimen for the last 3 months or more, but now requiring intensification (dose-increase or additional therapy)
• Signed and dated written informed consent in accordance with GCP and local legislation prior to the start of any screening procedures