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

NCT ID: NCT02849951

Last Updated: 2017-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-08-31

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

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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.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LT-02

1.6 g PC in LT-02 BID

Group Type EXPERIMENTAL

LT-02

Intervention Type DRUG

12-weeks of 1.6 g BID delayed-release phosphatidylcholine (LT-02)

LT-02 Placebo

0 g PC in LT-02 Placebo BID

Group Type PLACEBO_COMPARATOR

LT-02 Placebo

Intervention Type DRUG

12-weeks of 0 g BID delayed-release phosphatidylcholine (LT-02) placebo

Interventions

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LT-02

12-weeks of 1.6 g BID delayed-release phosphatidylcholine (LT-02)

Intervention Type DRUG

LT-02 Placebo

12-weeks of 0 g BID delayed-release phosphatidylcholine (LT-02) placebo

Intervention Type DRUG

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nestlé Health Science Spain

INDUSTRY

Sponsor Role collaborator

Syneos Health

OTHER

Sponsor Role collaborator

Prometheus Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory Gordon, M.D., J.D.

Role: STUDY_DIRECTOR

Nestle Health Science, Medical Director

Locations

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Prometheus Site 24

Phoenix, Arizona, United States

Site Status

Prometheus Site 10

Little Rock, Arkansas, United States

Site Status

Prometheus Site 15

Chula Vista, California, United States

Site Status

Prometheus Site 42

Lancaster, California, United States

Site Status

Prometheus Site 30

Oceanside, California, United States

Site Status

Prometheus Site 28

Rialto, California, United States

Site Status

Prometheus Site 2

Ventura, California, United States

Site Status

Prometheus Site 27

Lafayette, Colorado, United States

Site Status

Prometheus Site 45

Lone Tree, Colorado, United States

Site Status

Prometheus Site 35

Clearwater, Florida, United States

Site Status

Prometheus Site 17

Fort Lauderdale, Florida, United States

Site Status

Prometheus Site 55

Hialeah, Florida, United States

Site Status

Prometheus Site 8

Naples, Florida, United States

Site Status

Prometheus Site 13

Naples, Florida, United States

Site Status

Prometheus Site 36

Orlando, Florida, United States

Site Status

Prometheus Site 44

Orlando, Florida, United States

Site Status

Prometheus Site 37

Athens, Georgia, United States

Site Status

Prometheus Site 11

Decatur, Georgia, United States

Site Status

Prometheus Site 53

Chicago, Illinois, United States

Site Status

Prometheus Site 54

Hoffman Estates, Illinois, United States

Site Status

Prometheus Site 20

Topeka, Kansas, United States

Site Status

Prometheus Site 4

Shreveport, Louisiana, United States

Site Status

Prometheus Site 5

Chevy Chase, Maryland, United States

Site Status

Prometheus Research Site 1

Brockton, Massachusetts, United States

Site Status

Prometheus Site 6

Chesterfield, Michigan, United States

Site Status

Prometheus Site 51

Southfield, Michigan, United States

Site Status

Prometheus Site 48

Wyoming, Michigan, United States

Site Status

Prometheus Site 31

Plymouth, Minnesota, United States

Site Status

Prometheus Site 40

St Louis, Missouri, United States

Site Status

Prometheus Site 21

Lebanon, New Hampshire, United States

Site Status

Prometheus Site 22

Great Neck, New York, United States

Site Status

Prometheus Site 33

Poughkeepsie, New York, United States

Site Status

Prometheus Site 26

The Bronx, New York, United States

Site Status

Prometheus Site 41

Greenville, North Carolina, United States

Site Status

Prometheus Site 32

Kinston, North Carolina, United States

Site Status

Prometheus Site 43

Columbia, South Carolina, United States

Site Status

Prometheus Site 7

Rapid City, South Dakota, United States

Site Status

Prometheus Site 49

Houston, Texas, United States

Site Status

Prometheus Site 39

Humble, Texas, United States

Site Status

Prometheus Site 47

San Antonio, Texas, United States

Site Status

Prometheus Site 9

San Antonio, Texas, United States

Site Status

Prometheus Site 23

Orem, Utah, United States

Site Status

Prometheus Site 25

Salt Lake City, Utah, United States

Site Status

Prometheus Site 34

Charlottesville, Virginia, United States

Site Status

Prometheus Site 12

Richland, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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16GI01

Identifier Type: -

Identifier Source: org_study_id

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