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

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Disease Information

Descriptive Information
Brief Title † A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)
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
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
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 Phase Phase 3
Study Type † Interventional
Study Design †
Primary Outcome Measure † Rate of clinical remission
Secondary Outcome Measure † Clinical response
Condition † Ulcerative Colitis
Intervention † DrugLT-02
Study Arms / Comparison Groups LT-02 1.6 g PC in LT-02 BID LT-02 Placebo 0 g PC in LT-02 Placebo BID
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 25
Start Date † July 2016
Completion Date August 2019
Primary Completion Date March 2019
Eligibility 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,
Gender All
Ages 18 Years - 70 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT02849951
Organization ID 16GI01
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Prometheus Laboratories
Collaborators †† Nestlé Health Science Spain
Investigators † Study Director: Gregory Gordon, M.D., J.D., Nestle Health Science, Medical Director
Information Provided By
Verification Date June 2017
First Received Date † July 26, 2016
Last Updated Date June 13, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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