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

Study Overview
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Brief Summary
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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)

Official Title
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Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 48-weeks Treatment With Gastro-resistant Phosphatidylcholine (LT-02) Versus Placebo Versus Mesalamine for Maintenance of Remission in Patients With Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: LT-02
* Drug: Placebo
* Drug: Mesalamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LT-02<br>LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily | Drug: LT-02<br>* LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily<br>|
| Placebo Comparator: Placebo<br>LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily | Drug: Placebo<br>* LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily<br>|
| Active Comparator: Mesalamine<br>LT-02 PLACEBO twice daily AND 500mg mesalamine PLACEBO three-times daily | Drug: Mesalamine<br>* LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who are relapse-free and are not a treatment failure |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in the total mDAI |  | 48 weeks |