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

Sponsor
Prometheus Laboratories (Industry)
Overall Status
Terminated
CT.gov ID
NCT02849951
Collaborator
Nestlé Health Science Spain (Industry), Syneos Health (Other)
25
Enrollment
45
Locations
2
Arms
37
Duration (Months)
0.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jul 1, 2016
Anticipated Primary Completion Date :
Mar 1, 2019
Anticipated Study Completion Date :
Aug 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Rate of clinical remission [12 weeks]

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

Secondary Outcome Measures

  1. Clinical response [12 weeks]

    Percentage of subjects with clinical response using the abbreviated modified Mayo score

  2. Endoscopic response [12 weeks]

    Percentage of subjects with endoscopic response

  3. Histological improvement [12 weeks]

    Percentage of subjects with histological improvement

  4. Endoscopic remission [12 weeks]

    Percentage of subjects with endoscopic remission

  5. Mucosal healing [12 weeks]

    Percentage of subjects with mucosal healing

  6. Quality of life [12 weeks]

    Change in the subjects quality of life, using Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Prometheus Laboratories
  • Nestlé Health Science Spain
  • Syneos Health

Investigators

  • Study Director: Gregory Gordon, M.D., J.D., Nestle Health Science, Medical Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prometheus Laboratories
ClinicalTrials.gov Identifier:
NCT02849951
Other Study ID Numbers:
  • 16GI01
First Posted:
Jul 29, 2016
Last Update Posted:
Jun 15, 2017
Last Verified:
Jun 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Prometheus Laboratories
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Mesalamine
Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer

Study Results

No Results Posted as of Jun 15, 2017