Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis

Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine

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