NCT02849951

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Prometheus Laboratories · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	LT-02	12-weeks of 1.6 g BID delayed-release phosphatidylcholine (LT-02)
DRUG	LT-02 Placebo	12-weeks of 0 g BID delayed-release phosphatidylcholine (LT-02) placebo

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-03-01
• Completion: 2019-08-01
• First posted: 2016-07-29
• Last updated: 2017-06-15

Locations

45 sites across 1 country: United States