A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC) (PROTECT-3)

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

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: LT-02; Drug: LT-02 Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Prometheus Site 24
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Prometheus Site 10
  • California
    • Chula Vista, California, United States, 91910
      • Prometheus Site 15
    • Lancaster, California, United States, 93534
      • Prometheus Site 42
    • Oceanside, California, United States, 92056
      • Prometheus Site 30
    • Rialto, California, United States, 92377
      • Prometheus Site 28
    • Ventura, California, United States, 93003
      • Prometheus Site 2
  • Colorado
    • Lafayette, Colorado, United States, 80026
      • Prometheus Site 27
    • Lone Tree, Colorado, United States, 80124
      • Prometheus Site 45
  • Florida
    • Clearwater, Florida, United States, 33756
      • Prometheus Site 35
    • Fort Lauderdale, Florida, United States, 33319
      • Prometheus Site 17
    • Hialeah, Florida, United States, 33016
      • Prometheus Site 55
    • Naples, Florida, United States, 34102
      • Prometheus Site 8
    • Naples, Florida, United States, 34110
      • Prometheus Site 13
    • Orlando, Florida, United States, 32803
      • Prometheus Site 36
    • Orlando, Florida, United States, 32807
      • Prometheus Site 44
  • Georgia
    • Athens, Georgia, United States, 30607
      • Prometheus Site 37
    • Decatur, Georgia, United States, 30033
      • Prometheus Site 11
  • Illinois
    • Chicago, Illinois, United States, 60624
      • Prometheus Site 53
    • Hoffman Estates, Illinois, United States, 60169
      • Prometheus Site 54
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Prometheus Site 20
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Prometheus Site 4
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Prometheus Site 5
  • Massachusetts
    • Brockton, Massachusetts, United States, 02379
      • Prometheus Research Site 1
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Prometheus Site 6
    • Southfield, Michigan, United States, 48034
      • Prometheus Site 51
    • Wyoming, Michigan, United States, 49519
      • Prometheus Site 48
  • Minnesota
    • Plymouth, Minnesota, United States, 55446
      • Prometheus Site 31
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Prometheus Site 40
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Prometheus Site 21
  • New York
    • Great Neck, New York, United States, 11021
      • Prometheus Site 22
    • Poughkeepsie, New York, United States, 12601
      • Prometheus Site 33
    • The Bronx, New York, United States, 10467
      • Prometheus Site 26
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Prometheus Site 41
    • Kinston, North Carolina, United States, 28501
      • Prometheus Site 32
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Prometheus Site 43
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Prometheus Site 7
  • Texas
    • Houston, Texas, United States, 77090
      • Prometheus Site 49
    • Humble, Texas, United States, 77338
      • Prometheus Site 39
    • San Antonio, Texas, United States, 78229
      • Prometheus Site 47
    • San Antonio, Texas, United States, 78229
      • Prometheus Site 9
  • Utah
    • Orem, Utah, United States, 84058
      • Prometheus Site 23
    • Salt Lake City, Utah, United States, 84107
      • Prometheus Site 25
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Prometheus Site 34
  • Washington
    • Richland, Washington, United States, 99352
      • Prometheus Site 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LT-02; 1.6 g PC in LT-02 BID	Drug: LT-02; 12-weeks of 1.6 g BID delayed-release phosphatidylcholine (LT-02)
Placebo Comparator: LT-02 Placebo; 0 g PC in LT-02 Placebo BID	Drug: LT-02 Placebo; 12-weeks of 0 g BID delayed-release phosphatidylcholine (LT-02) placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of clinical remission	The percentage of subjects in clinical remission using the abbreviated modified Mayo score	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response	Percentage of subjects with clinical response using the abbreviated modified Mayo score	12 weeks
Endoscopic response	Percentage of subjects with endoscopic response	12 weeks
Histological improvement	Percentage of subjects with histological improvement	12 weeks
Endoscopic remission	Percentage of subjects with endoscopic remission	12 weeks
Mucosal healing	Percentage of subjects with mucosal healing	12 weeks
Quality of life	Change in the subjects quality of life, using Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ)	12 weeks

Collaborators and Investigators

• Sponsor: Prometheus Laboratories
• Collaborators: Syneos Health; Nestlé Health Science Spain
• Investigators: Study Director: Gregory Gordon, M.D., J.D., Nestle Health Science, Medical Director

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Actual): June 15, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Pathologic Processes; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Colitis, Ulcerative; Colitis; Ulcer; Mesalamine
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 16GI01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No