IDMC recommendation

The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.

Inclusion Criteria:

• Established diagnosis of ulcerative colitis
• Active ulcerative colitis disease extent ≥ 15 cm
• Active disease despite treatment with mesalamine

Exclusion Criteria:

• Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis, diverticular disease associated colitis,
• Toxic megacolon or fulminant colitis
• Colon resection
• Evidence of infectious colitis
• Celiac disease
• Bleeding hemorrhoids
• History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack
• Any severe concomitant renal, endocrine, or psychiatric disorder
• Any relevant known systemic disease
• History of cancer in the last five years
• Abnormal hepatic function or liver cirrhosis
• Abnormal HbA1c at screening visit
• Patients with known hypersensitivity to soy
• Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP)
• Treatment with steroids/methotrexate/Tumor necrosis factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins
• Treatment with other investigational drug
• Existing or intended pregnancy or breast-feeding