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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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

Key facts

Study ID

NCT02849951

Run by

Prometheus Laboratories

People needed

25

Starts

2016-07-01

Expected to finish

2019-08-01

Last updated by the study team

2017-06-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis,
• Toxic megacolon or fulminant colitis,
• Prior colon resection,
• Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile infection) at screening,
• Known celiac disease
• Other inflammatory or bleeding disorders of the colon and intestine, or diseases what may cause diarrhea or gastrointestinal bleeding
• History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack,
• Subjects with known hypersensitivity to soy,
• 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,
• Treatment with any (topical or systemic) corticosteroid formulation for the treatment of IBD within last 7 days prior to endoscopy,
• Treatment with other investigational drug within last 8 weeks prior to screening,

Where it is running

• Prometheus Site 24 — Phoenix, Arizona, United States
• Prometheus Site 10 — Little Rock, Arkansas, United States
• Prometheus Site 15 — Chula Vista, California, United States
• Prometheus Site 42 — Lancaster, California, United States
• Prometheus Site 30 — Oceanside, California, United States
• Prometheus Site 28 — Rialto, California, United States
• Prometheus Site 2 — Ventura, California, United States
• Prometheus Site 27 — Lafayette, Colorado, United States
• Prometheus Site 45 — Lone Tree, Colorado, United States
• Prometheus Site 35 — Clearwater, Florida, United States
• Prometheus Site 17 — Fort Lauderdale, Florida, United States
• Prometheus Site 55 — Hialeah, Florida, United States
• Prometheus Site 8 — Naples, Florida, United States
• Prometheus Site 13 — Naples, Florida, United States
• Prometheus Site 36 — Orlando, Florida, United States
• Prometheus Site 44 — Orlando, Florida, United States
• Prometheus Site 37 — Athens, Georgia, United States
• Prometheus Site 11 — Decatur, Georgia, United States
• Prometheus Site 53 — Chicago, Illinois, United States
• Prometheus Site 54 — Hoffman Estates, Illinois, United States
• Prometheus Site 20 — Topeka, Kansas, United States
• Prometheus Site 4 — Shreveport, Louisiana, United States
• Prometheus Site 5 — Chevy Chase, Maryland, United States
• Prometheus Research Site 1 — Brockton, Massachusetts, United States
• Prometheus Site 6 — Chesterfield, Michigan, United States

Full record on ClinicalTrials.gov

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