Clinical Trials Logo
  1. Home
  2. Ulcerative Colitis
  3. NCT02849951
  4. Details
NCT02849951 Clinical Trial

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

Ulcerative Colitis Clinical Trial

— PROTECT-3  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02849951
Other study ID # 16GI01
Secondary ID
Status Terminated
Phase Phase 3
First received July 26, 2016
Last updated June 13, 2017
Start date July 2016
Est. completion date August 2019

Study information
Verified date June 2017
Source Prometheus Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 25
Est. completion date August 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• LT-02
12-weeks of 1.6 g BID delayed-release phosphatidylcholine (LT-02)
• LT-02 Placebo
12-weeks of 0 g BID delayed-release phosphatidylcholine (LT-02) placebo

Locations
Country Name City State
United States Prometheus Site 37 Athens Georgia
United States Prometheus Research Site 1 Brockton Massachusetts
United States Prometheus Site 34 Charlottesville Virginia
United States Prometheus Site 6 Chesterfield Michigan
United States Prometheus Site 5 Chevy Chase Maryland
United States Prometheus Site 53 Chicago Illinois
United States Prometheus Site 15 Chula Vista California
United States Prometheus Site 35 Clearwater Florida
United States Prometheus Site 43 Columbia South Carolina
United States Prometheus Site 11 Decatur Georgia
United States Prometheus Site 17 Fort Lauderdale Florida
United States Prometheus Site 22 Great Neck New York
United States Prometheus Site 41 Greenville North Carolina
United States Prometheus Site 55 Hialeah Florida
United States Prometheus Site 54 Hoffman Estates Illinois
United States Prometheus Site 49 Houston Texas
United States Prometheus Site 39 Humble Texas
United States Prometheus Site 32 Kinston North Carolina
United States Prometheus Site 27 Lafayette Colorado
United States Prometheus Site 42 Lancaster California
United States Prometheus Site 21 Lebanon New Hampshire
United States Prometheus Site 10 Little Rock Arkansas
United States Prometheus Site 45 Lone Tree Colorado
United States Prometheus Site 13 Naples Florida
United States Prometheus Site 8 Naples Florida
United States Prometheus Site 30 Oceanside California
United States Prometheus Site 23 Orem Utah
United States Prometheus Site 36 Orlando Florida
United States Prometheus Site 44 Orlando Florida
United States Prometheus Site 24 Phoenix Arizona
United States Prometheus Site 31 Plymouth Minnesota
United States Prometheus Site 33 Poughkeepsie New York
United States Prometheus Site 7 Rapid City South Dakota
United States Prometheus Site 28 Rialto California
United States Prometheus Site 12 Richland Washington
United States Prometheus Site 40 Saint Louis Missouri
United States Prometheus Site 25 Salt Lake City Utah
United States Prometheus Site 47 San Antonio Texas
United States Prometheus Site 9 San Antonio Texas
United States Prometheus Site 4 Shreveport Louisiana
United States Prometheus Site 51 Southfield Michigan
United States Prometheus Site 26 The Bronx New York
United States Prometheus Site 20 Topeka Kansas
United States Prometheus Site 2 Ventura California
United States Prometheus Site 48 Wyoming Michigan

Sponsors (3)
Lead Sponsor Collaborator
Prometheus Laboratories INC Research, Nestlé Health Science Spain

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of clinical remission The percentage of subjects in clinical remission using the abbreviated modified Mayo score 12 weeks
Secondary Clinical response Percentage of subjects with clinical response using the abbreviated modified Mayo score 12 weeks
Secondary Endoscopic response Percentage of subjects with endoscopic response 12 weeks
Secondary Histological improvement Percentage of subjects with histological improvement 12 weeks
Secondary Endoscopic remission Percentage of subjects with endoscopic remission 12 weeks
Secondary Mucosal healing Percentage of subjects with mucosal healing 12 weeks
Secondary Quality of life Change in the subjects quality of life, using Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ) 12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05702879 - Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
Not yet recruiting NCT05953402 - A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Recruiting NCT03950232 - An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT03124121 - Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels Phase 4
Not yet recruiting NCT06100289 - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Phase 3
Withdrawn NCT04209556 - A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis Phase 2
Terminated NCT00061282 - Clotrimazole Enemas for Pouchitis in Children and Adults Phase 1/Phase 2
Recruiting NCT04398550 - SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis N/A
Recruiting NCT04314375 - Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis Phase 4
Active, not recruiting NCT04857112 - Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis Phase 2
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Active, not recruiting NCT04033445 - A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis Phase 2/Phase 3
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Active, not recruiting NCT06221995 - Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
Recruiting NCT04767984 - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis Phase 2
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Recruiting NCT06071312 - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach Phase 1/Phase 2
Completed NCT03760003 - Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis Phase 2
Not yet recruiting NCT05539625 - Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis Phase 2