A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)
- Registration Number
- NCT02849951
- Lead Sponsor
- Prometheus Laboratories
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
- 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.
- 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,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LT-02 Placebo LT-02 Placebo 0 g PC in LT-02 Placebo BID LT-02 LT-02 1.6 g PC in LT-02 BID
- Primary Outcome Measures
Name Time Method Rate of clinical remission 12 weeks The percentage of subjects in clinical remission using the abbreviated modified Mayo score
- Secondary Outcome Measures
Name Time Method Endoscopic response 12 weeks Percentage of subjects with endoscopic response
Histological improvement 12 weeks Percentage of subjects with histological improvement
Clinical response 12 weeks Percentage of subjects with clinical response using the abbreviated modified Mayo score
Mucosal healing 12 weeks Percentage of subjects with mucosal healing
Quality of life 12 weeks Change in the subjects quality of life, using Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ)
Endoscopic remission 12 weeks Percentage of subjects with endoscopic remission
Trial Locations
- Locations (45)
Prometheus Site 42
🇺🇸Lancaster, California, United States
Prometheus Site 35
🇺🇸Clearwater, Florida, United States
Prometheus Site 53
🇺🇸Chicago, Illinois, United States
Prometheus Site 51
🇺🇸Southfield, Michigan, United States
Prometheus Site 32
🇺🇸Kinston, North Carolina, United States
Prometheus Site 22
🇺🇸Great Neck, New York, United States
Prometheus Site 43
🇺🇸Columbia, South Carolina, United States
Prometheus Site 7
🇺🇸Rapid City, South Dakota, United States
Prometheus Site 34
🇺🇸Charlottesville, Virginia, United States
Prometheus Site 2
🇺🇸Ventura, California, United States
Prometheus Site 12
🇺🇸Richland, Washington, United States
Prometheus Site 39
🇺🇸Humble, Texas, United States
Prometheus Site 15
🇺🇸Chula Vista, California, United States
Prometheus Site 9
🇺🇸San Antonio, Texas, United States
Prometheus Site 24
🇺🇸Phoenix, Arizona, United States
Prometheus Site 49
🇺🇸Houston, Texas, United States
Prometheus Site 47
🇺🇸San Antonio, Texas, United States
Prometheus Site 25
🇺🇸Salt Lake City, Utah, United States
Prometheus Site 10
🇺🇸Little Rock, Arkansas, United States
Prometheus Site 28
🇺🇸Rialto, California, United States
Prometheus Site 30
🇺🇸Oceanside, California, United States
Prometheus Site 45
🇺🇸Lone Tree, Colorado, United States
Prometheus Site 17
🇺🇸Fort Lauderdale, Florida, United States
Prometheus Site 36
🇺🇸Orlando, Florida, United States
Prometheus Site 11
🇺🇸Decatur, Georgia, United States
Prometheus Site 44
🇺🇸Orlando, Florida, United States
Prometheus Site 20
🇺🇸Topeka, Kansas, United States
Prometheus Site 4
🇺🇸Shreveport, Louisiana, United States
Prometheus Site 5
🇺🇸Chevy Chase, Maryland, United States
Prometheus Research Site 1
🇺🇸Brockton, Massachusetts, United States
Prometheus Site 31
🇺🇸Plymouth, Minnesota, United States
Prometheus Site 6
🇺🇸Chesterfield, Michigan, United States
Prometheus Site 48
🇺🇸Wyoming, Michigan, United States
Prometheus Site 40
🇺🇸Saint Louis, Missouri, United States
Prometheus Site 21
🇺🇸Lebanon, New Hampshire, United States
Prometheus Site 41
🇺🇸Greenville, North Carolina, United States
Prometheus Site 23
🇺🇸Orem, Utah, United States
Prometheus Site 13
🇺🇸Naples, Florida, United States
Prometheus Site 55
🇺🇸Hialeah, Florida, United States
Prometheus Site 33
🇺🇸Poughkeepsie, New York, United States
Prometheus Site 27
🇺🇸Lafayette, Colorado, United States
Prometheus Site 8
🇺🇸Naples, Florida, United States
Prometheus Site 54
🇺🇸Hoffman Estates, Illinois, United States
Prometheus Site 37
🇺🇸Athens, Georgia, United States
Prometheus Site 26
🇺🇸The Bronx, New York, United States