Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02849951
Recruitment Status : Terminated (LT-02 did not appear to help induce remission of UC)
First Posted : July 29, 2016
Last Update Posted : June 15, 2017
Sponsor:
Collaborators:
Nestlé Health Science Spain
Syneos Health
Information provided by (Responsible Party):
Prometheus Laboratories

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
Ulcerative Colitis Drug: LT-02 Drug: LT-02 Placebo 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : July 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Rate of clinical remission [ Time Frame: 12 weeks ]
    The percentage of subjects in clinical remission using the abbreviated modified Mayo score


Secondary Outcome Measures :
  1. Clinical response [ Time Frame: 12 weeks ]
    Percentage of subjects with clinical response using the abbreviated modified Mayo score

  2. Endoscopic response [ Time Frame: 12 weeks ]
    Percentage of subjects with endoscopic response

  3. Histological improvement [ Time Frame: 12 weeks ]
    Percentage of subjects with histological improvement

  4. Endoscopic remission [ Time Frame: 12 weeks ]
    Percentage of subjects with endoscopic remission

  5. Mucosal healing [ Time Frame: 12 weeks ]
    Percentage of subjects with mucosal healing

  6. Quality of life [ Time Frame: 12 weeks ]
    Change in the subjects quality of life, using Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849951


  Show 45 Study Locations
Sponsors and Collaborators
Prometheus Laboratories
Nestlé Health Science Spain
Syneos Health
Investigators
Layout table for investigator information
Study Director: Gregory Gordon, M.D., J.D. Nestle Health Science, Medical Director

Layout table for additonal information
Responsible Party: Prometheus Laboratories
ClinicalTrials.gov Identifier: NCT02849951     History of Changes
Other Study ID Numbers: 16GI01
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents