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

Dr. Falk Pharma

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Mesalamine; Drug: LT-02

Study type: Interventional

Funder types: Industry

Identifiers

NCT02280629

2013-001205-84 (EudraCT Number)

PCG-4/UCR

Details and patient eligibility

About

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)

Enrollment: 150 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

LT-02

Experimental group

Description:

LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily

Treatment:

Drug: LT-02

Placebo

Placebo Comparator group

Description:

LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily

Treatment:

Drug: Placebo

Mesalamine

Active Comparator group

Description:

LT-02 PLACEBO twice daily AND 500mg mesalamine PLACEBO three-times daily

Treatment:

Drug: Mesalamine