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
Lancaster, California 93534
1149
mi
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Lancaster, CA
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Athens, Georgia 30607
849
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Athens, GA
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Brockton, Massachusetts 02379
1445
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Brockton, MA
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Bronx, New York 10467
1291
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Bronx, NY
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Charlottesville, Virginia 22911
1053
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Charlottesville, VA
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Chesterfield, Michigan 48047
858
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Chesterfield, MI
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Chevy Chase, Maryland 20815
1124
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Chevy Chase, MD
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Chicago, Illinois 60624
609
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Chicago, IL
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Chula Vista, California 91910
1140
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Chula Vista, CA
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Clearwater, Florida 33756
1100
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Clearwater, FL
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Columbia, South Carolina 29203
973
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Columbia, SC
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Decatur, Georgia 30033
805
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Decatur, GA
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Fort Lauderdale, Florida 33319
1307
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Fort Lauderdale, FL
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Great Neck, New York 11021
1301
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Great Neck, NY
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Greenville, North Carolina 27834
1140
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Greenville, NC
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Hialeah, Florida 33016
1313
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Hialeah, FL
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Hoffman Estates, Illinois 60169
594
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Hoffman Estates, IL
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Houston, Texas 77090
569
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Houston, TX
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Humble, Texas 77338
555
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Humble, TX
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Kinston, North Carolina 28501
1134
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Kinston, NC
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Lafayette, Colorado 80026
420
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Lafayette, CO
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Lebanon, New Hampshire 03756
1393
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Lebanon, NH
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Little Rock, Arkansas 72205
371
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Little Rock, AR
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Lone Tree, Colorado 80124
400
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Lone Tree, CO
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Naples, Florida 34102
1232
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Naples, FL
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Oceanside, California 92056
1142
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Orem, Utah 84058
764
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Orlando, Florida 32803
1141
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Phoenix, Arizona 85018
852
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Phoenix, AZ
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Plymouth, Minnesota 55446
550
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Poughkeepsie, New York 12601
1294
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Rapid City, South Dakota 57701
520
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Rapid City, SD
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Rialto, California 92377
1119
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Rialto, CA
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Richland, Washington 99352
1243
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Richland, WA
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Saint Louis, Missouri 63128
418
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Saint Louis, MO
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Salt Lake City, Utah 84107
779
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San Antonio, Texas 78229
576
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San Antonio, TX
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Shreveport, Louisiana 71105
428
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Southfield, Michigan 48034
836
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Southfield, MI
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Topeka, Kansas 66606
146
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Topeka, KS
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Ventura, California 93003
1220
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Ventura, CA
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Wyoming, Michigan 49519
730
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Wyoming, MI
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