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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ulcerative Colitis

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


Participation Criteria
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Eligibility Criteria
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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

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 0.8g four times daily | Drug: LT-02<br>* four times per day<br>|
| Experimental: B: LT-02<br>LT-02 1.6g twice daily | Drug: LT-02<br>* two times per day<br>|
| Placebo Comparator: Placebo<br>LT-02 Placebo | Drug: Placebo<br>* four times per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical remission |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with clinical improvement |  | 12 weeks | 
| Time to first resolution of symptoms |  | 12 weeks | 
| Number of stools per week |  | 12 weeks | 
| Number of days with urgency per week |  | 12 weeks | 
| Rate of mucosal healing |  | 12 weeks | 
| Rate of histologic remission |  | 12 weeks | 
| Physician's global assessment at final visit |  | 12 weeks | 
| Quality of life |  | 12 weeks |