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

NCT02849951 | Terminated Phase 3

• 1 other identifier: 16GI01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 45

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

Conditions

Ulcerative Colitis

Keywords

Colitis; Colitis, Ulcerative; Ulcer; Colonic Diseases; Digestive System Diseases; Gastroenteritis; Gastrointestinal Diseases; Inflammatory Bowel Diseases; Intestinal Diseases; Pathologic Processes; Mesalamine

Outcome Measures

Primary Outcomes (1)

• Rate of clinical remission

  The percentage of subjects in clinical remission using the abbreviated modified Mayo score

  12 weeks

Secondary Outcomes (6)

• Clinical response

  12 weeks

• Endoscopic response

  12 weeks

• Histological improvement

  12 weeks

• Endoscopic remission

  12 weeks

• Mucosal healing

  12 weeks

Study Arms (2)

LT-02

EXPERIMENTAL

1.6 g PC in LT-02 BID

Drug: LT-02

LT-02 Placebo

PLACEBO COMPARATOR

0 g PC in LT-02 Placebo BID

Drug: LT-02 Placebo

Interventions

LT-02 DRUG

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

LT-02

LT-02 Placebo DRUG

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

LT-02 Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Prometheus Laboratories: lead
• Nestlé Health Science Spain: collaborator
• Syneos Health: collaborator

Study Sites (45)

Prometheus Site 24

Phoenix, Arizona, 85018, United States

Location

Prometheus Site 10

Little Rock, Arkansas, 72205, United States

Location

Prometheus Site 15

Chula Vista, California, 91910, United States

Location

Prometheus Site 42

Lancaster, California, 93534, United States

Location

Prometheus Site 30

Oceanside, California, 92056, United States

Location

Prometheus Site 28

Rialto, California, 92377, United States

Location

Prometheus Site 2

Ventura, California, 93003, United States

Location

Prometheus Site 27

Lafayette, Colorado, 80026, United States

Location

Prometheus Site 45

Lone Tree, Colorado, 80124, United States

Location

Prometheus Site 35

Clearwater, Florida, 33756, United States

Location

Prometheus Site 17

Fort Lauderdale, Florida, 33319, United States

Location

Prometheus Site 55

Hialeah, Florida, 33016, United States

Location

Prometheus Site 8

Naples, Florida, 34102, United States

Location

Prometheus Site 13

Naples, Florida, 34110, United States

Location

Prometheus Site 36

Orlando, Florida, 32803, United States

Location

Prometheus Site 44

Orlando, Florida, 32807, United States

Location

Prometheus Site 37

Athens, Georgia, 30607, United States

Location

Prometheus Site 11

Decatur, Georgia, 30033, United States

Location

Prometheus Site 53

Chicago, Illinois, 60624, United States

Location

Prometheus Site 54

Hoffman Estates, Illinois, 60169, United States

Location

Prometheus Site 20

Topeka, Kansas, 66606, United States

Location

Prometheus Site 4

Shreveport, Louisiana, 71105, United States

Location

Prometheus Site 5

Chevy Chase, Maryland, 20815, United States

Location

Prometheus Research Site 1

Brockton, Massachusetts, 02379, United States

Location

Prometheus Site 6

Chesterfield, Michigan, 48047, United States

Location

Prometheus Site 51

Southfield, Michigan, 48034, United States

Location

Prometheus Site 48

Wyoming, Michigan, 49519, United States

Location

Prometheus Site 31

Plymouth, Minnesota, 55446, United States

Location

Prometheus Site 40

St Louis, Missouri, 63128, United States

Location

Prometheus Site 21

Lebanon, New Hampshire, 03756, United States

Location

Prometheus Site 22

Great Neck, New York, 11021, United States

Location

Prometheus Site 33

Poughkeepsie, New York, 12601, United States

Location

Prometheus Site 26

The Bronx, New York, 10467, United States

Location

Prometheus Site 41

Greenville, North Carolina, 27834, United States

Location

Prometheus Site 32

Kinston, North Carolina, 28501, United States

Location

Prometheus Site 43

Columbia, South Carolina, 29203, United States

Location

Prometheus Site 7

Rapid City, South Dakota, 57701, United States

Location

Prometheus Site 49

Houston, Texas, 77090, United States

Location

Prometheus Site 39

Humble, Texas, 77338, United States

Location

Prometheus Site 47

San Antonio, Texas, 78229, United States

Location

Prometheus Site 9

San Antonio, Texas, 78229, United States

Location

Prometheus Site 23

Orem, Utah, 84058, United States

Location

Prometheus Site 25

Salt Lake City, Utah, 84107, United States

Location

Prometheus Site 34

Charlottesville, Virginia, 22911, United States

Location

Prometheus Site 12

Richland, Washington, 99352, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Colitis; Ulcer; Colonic Diseases; Digestive System Diseases; Gastroenteritis; Gastrointestinal Diseases; Inflammatory Bowel Diseases; Intestinal Diseases; Pathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory Gordon, M.D., J.D.

  Nestle Health Science, Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: July 29, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 15, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (45)