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

June 13, 2017 updated by: Prometheus Laboratories

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of clinical remission
Time Frame: 12 weeks
The percentage of subjects in clinical remission using the abbreviated modified Mayo score
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: 12 weeks
Percentage of subjects with clinical response using the abbreviated modified Mayo score
12 weeks
Endoscopic response
Time Frame: 12 weeks
Percentage of subjects with endoscopic response
12 weeks
Histological improvement
Time Frame: 12 weeks
Percentage of subjects with histological improvement
12 weeks
Endoscopic remission
Time Frame: 12 weeks
Percentage of subjects with endoscopic remission
12 weeks
Mucosal healing
Time Frame: 12 weeks
Percentage of subjects with mucosal healing
12 weeks
Quality of life
Time Frame: 12 weeks
Change in the subjects quality of life, using Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prometheus Laboratories

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Syneos Health
Nestlé Health Science Spain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gregory Gordon, M.D., J.D., Nestle Health Science, Medical Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16GI01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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