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



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:12/24/2016
Start Date:July 2016
End Date:August 2019
Contact:JoAnne DePaceForrest
Email:joanne.depaceforrest@incresearch.com
Phone:(919) 987-7153

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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

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

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.

Key Inclusion Criteria:

1. Established diagnosis of ulcerative colitis (UC), based on clinical history,
exclusion of infectious causes, and characteristic endoscopic and histologic
findings.

2. Active UC with disease confirmed by endoscopy findings and confirmed by central
reader.

3. A modified Mayo Score 4-10, and with a centrally read endoscopy score activity of ≥ 2
points.

4. Mesalamine (5-ASA) refractory.

Exclusion Criteria:

1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, radiation
colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis),
diverticular disease associated colitis,

2. Toxic megacolon or fulminant colitis,

3. Prior colon resection,

4. Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile
infection) at screening,

5. Known celiac disease

6. Other inflammatory or bleeding disorders of the colon and intestine, or diseases what
may cause diarrhea or gastrointestinal bleeding

7. History or presence of ischemic heart disease, myocardial infarction, peripheral
arterial disease, ischemic stroke, or transient ischemic attack,

8. Subjects with known hypersensitivity to soy,

9. 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,

10. Treatment with any (topical or systemic) corticosteroid formulation for the treatment
of IBD within last 7 days prior to endoscopy,

11. Treatment with other investigational drug within last 8 weeks prior to screening,
We found this trial at
42
sites
Topeka, Kansas 66606
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Athens, Georgia 30607
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Brockton, Massachusetts 02379
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Bronx, New York 10467
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Charlottesville, Virginia 22911
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Chesterfield, Michigan 48047
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Chevy Chase, Maryland 20815
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Chicago, Illinois 60624
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Chicago, IL
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Chula Vista, California 91910
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Clearwater, Florida 33756
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Columbia, South Carolina 29203
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Decatur, Georgia 30033
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Fort Lauderdale, Florida 33319
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Great Neck, New York 11021
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Greenville, North Carolina 27834
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Hialeah, Florida 33016
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Hoffman Estates, Illinois 60169
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Houston, Texas 77090
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Houston, TX
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Humble, Texas 77338
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Kinston, North Carolina 28501
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Lafayette, Colorado 80026
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Lancaster, California 93534
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Lebanon, New Hampshire 03756
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Little Rock, Arkansas 72205
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Lone Tree, Colorado 80124
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Naples, Florida 34102
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Oceanside, California 92056
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Orem, Utah 84058
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Orlando, Florida 32803
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Phoenix, Arizona 85018
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Plymouth, Minnesota 55446
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Poughkeepsie, New York 12601
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Rapid City, South Dakota 57701
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Rialto, California 92377
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Richland, Washington 99352
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Saint Louis, Missouri 63128
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Salt Lake City, Utah 84107
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San Antonio, Texas 78229
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Shreveport, Louisiana 71105
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Southfield, Michigan 48034
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Ventura, California 93003
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Wyoming, Michigan 49519
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