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
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
12-weeks of 1.6 g BID delayed-release phosphatidylcholine (LT-02)
12-weeks of 0 g BID delayed-release phosphatidylcholine (LT-02) placebo
Rate of clinical remission
The percentage of subjects in clinical remission using the abbreviated modified Mayo score
Time frame: 12 weeks
Clinical response
Percentage of subjects with clinical response using the abbreviated modified Mayo score
Time frame: 12 weeks
Endoscopic response
Percentage of subjects with endoscopic response
Time frame: 12 weeks
Histological improvement
Percentage of subjects with histological improvement
Time frame: 12 weeks
Endoscopic remission
Percentage of subjects with endoscopic remission
Time frame: 12 weeks
Mucosal healing
Percentage of subjects with mucosal healing
Time frame: 12 weeks
Quality of life
Change in the subjects quality of life, using Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ)
Time frame: 12 weeks
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...and 35 more locations