Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)

• Status: Completed
• Trial end date: 2018-10-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH
• Treatments: Mesalamine

Criteria

Major Inclusion Criteria:

• Signed informed consent

• Men or women, 18 to 70 years of age

• Historically confirmed diagnosis of UC by endoscopy and histology

• Patients being in clinical and endoscopical remission at baseline

• Negative pregnancy test in females of childbearing potential at baseline visit

Major Exclusion Criteria:

• Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis

• Toxic megacolon or fulminant colitis

• Colon resection

• Malabsorption syndromes

• Celiac disease

• Bleeding hemorrhoids

• Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding

• 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, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results

• Any relevant known systemic disease (e.g., AIDS, active tuberculosis)

• Severe co-morbidity substantially reducing life expectancy

• History of cancer in the last five years

• Abnormal hepatic function at screening visit, liver cirrhosis

• Abnormal renal function at screening visit

• Patients with known hypersensitivity to soy

• Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP: LT-02 or mesalamine)

• Treatment with steroids (oral, inhalative, or intravenous [IV]), cyclosporine or tacrolimus within last 4 weeks prior to randomization

• Treatment with methotrexate within last 6 weeks prior to randomization

• Treatment with TNF-alpha-antagonists, azathioprine, 6-mercaptopurine, or anti-integrin therapy within last 8 weeks prior to randomization

• Treatment with rectal mesalamine or corticosteroid formulations within last 2 weeks prior to randomization

• Treatment with other investigational drug within last 12 weeks prior to randomization except LT-02

• Existing or intended pregnancy or breast-feeding