A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Phosphatidylcholine (LT-02) add on treatment is effective and safe for the induction of remission in ulcerative colitis patients refractory to standard treatment with mesalamine

Detailed Description
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A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of LT-02 (delayed release phosphatidylcholine granules; administered orally via 1.6 g BID for up to 12 weeks) in subjects with active ulcerative colitis who are refractory to a standard dose of oral mesalamine therapy. Refractory to mesalamine is defined as active disease despite receiving at least ≥ 2.4g mesalamine (or equivalent dose) for at least 8 weeks with or without rectal 5-ASA.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of a 12-week Add-on Treatment With LT-02 vs. Placebo in Subjects 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 Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Established diagnosis of ulcerative colitis (UC), based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings. Active UC with disease confirmed by endoscopy findings and confirmed by central reader. A modified Mayo Score 4-10, and with a centrally read endoscopy score activity of ≥ 2 points. Mesalamine (5-ASA) refractory. Exclusion Criteria: Diagnosis of 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, Prior colon resection, Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile infection) at screening, Known celiac disease Other inflammatory or bleeding disorders of the colon and intestine, or diseases what may cause diarrhea or gastrointestinal bleeding History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack, Subjects with known hypersensitivity to soy, Treatment with methotrexate, azathioprine, 6-mercaptopurine TNF-alpha-antagonists, vedolizumab or certolizumab pegol, tacrolimus, or anti-integrin therapy within last 8 weeks prior to screening, Treatment with any (topical or systemic) corticosteroid formulation for the treatment of IBD within last 7 days prior to endoscopy, Treatment with other investigational drug within last 8 weeks prior to screening,

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>1.6 g PC in LT-02 BID | Drug: LT-02<br>* 12-weeks of 1.6 g BID delayed-release phosphatidylcholine (LT-02)<br>|
| Placebo Comparator: LT-02 Placebo<br>0 g PC in LT-02 Placebo BID | Drug: LT-02 Placebo<br>* 12-weeks of 0 g BID delayed-release phosphatidylcholine (LT-02) placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical remission | The percentage of subjects in clinical remission using the abbreviated modified Mayo score | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | Percentage of subjects with clinical response using the abbreviated modified Mayo score | 12 weeks | 
| Endoscopic response | Percentage of subjects with endoscopic response | 12 weeks | 
| Histological improvement | Percentage of subjects with histological improvement | 12 weeks | 
| Endoscopic remission | Percentage of subjects with endoscopic remission | 12 weeks | 
| Mucosal healing | Percentage of subjects with mucosal healing | 12 weeks | 
| Quality of life | Change in the subjects quality of life, using Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colitis, Colitis, Ulcerative, Ulcer, Colonic Diseases, Digestive System Diseases, Gastroenteritis, Gastrointestinal Diseases, Inflammatory Bowel Diseases, Intestinal Diseases, Pathologic Processes, Mesalamine