Modified-Release Phosphatidylcholine (LT-02) for Ulcerative Colitis: Two Double-Blind, Randomized, Placebo-Controlled Trials

Modified-Release Phosphatidylcholine (LT-02) for Ulcerative Colitis: Two Double-Blind, Randomized, Placebo-Controlled Trials

The aim of this study was to evaluate the efficacy of LT-02, a novel modified-release phosphatidylcholine (PC) formulation, for induction and maintenance of remission in patients with mild to moderate ulcerative colitis (UC) and inadequate response to mesalamine. LT-02 was evaluated in a multicenter...

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Published in:Clinical gastroenterology and hepatology Vol. 22; no. 4; pp. 810 - 820.e7
Main Authors: Dignass, Axel, Stremmel, Wolfgang, Horyński, Marek, Poyda, Oleksandr, Armerding, Peter, Fellermann, Klaus, Langhorst, Jost, Kuehbacher, Tanja, Uebel, Peter, Stein, Juergen, Novacek, Gottfried, Avalueva, Elena, Oliinyk, Oleksandr, Hasselblatt, Peter, Dorofeyev, Andrey, Heinemann, Heidrun, Mueller, Ralph, Greinwald, Roland, Reinisch, Walter
Format: Journal Article
Language:English
Published: United States Elsevier Inc 01-04-2024
Subjects:
Mesalamine
Mucus
Phosphatidylcholine
Ulcerative Colitis
CRP
Mesalamine
HI
EI
Mucus
CAI
mDAI
QID
UC
TEAE
IDMC
PC
Ulcerative Colitis
Phosphatidylcholine
FAS
BID
SHS
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Summary:The aim of this study was to evaluate the efficacy of LT-02, a novel modified-release phosphatidylcholine (PC) formulation, for induction and maintenance of remission in patients with mild to moderate ulcerative colitis (UC) and inadequate response to mesalamine. LT-02 was evaluated in a multicenter double-blind, randomized, placebo-controlled study comprising a 12-week induction trial (PCG-2), followed by a 48-week maintenance trial (PCG-4). In PCG-2, patients were randomized 1:1:1 to treatment with 0.8 g LT-02 4 times daily (QID), 1.6 g LT-02 twice daily (BID), or placebo, respectively. All patients continued to take a standard dose of oral mesalamine (≥2.4 g/day). The primary end point in PCG-2 was deep remission. Patients achieving remission at week 12 were randomly assigned 2:1:1 to 1.6 g LT-02 BID, placebo, or 500 mg mesalamine (3 times daily), respectively, in PCG-4; the primary end point was remission at 48 weeks. PCG-2 was terminated early for futility after a prespecified interim analysis; 466 patients (of 762 planned) were randomized. There was no statistically significant difference in deep remission at week 12 (placebo, 13.5%; LT-02 BID, 14.2%; LT-02 QID, 9.7%). In PCG-4, 150 patients (of approximately 400 planned) were randomized. There was no statistically significant difference in remission rates at week 48 (LT-02 BID, 49.3%; mesalamine, 50.0%; placebo, 43.2%). LT-02 was safe. Despite prior evidence of beneficial effects of PC in phase 2 trials, our induction study with LT-02 in patients with mild to moderate UC was terminated prematurely for futility. Signals of efficacy in maintenance therapy require confirmation in an adequately powered maintenance trial. LT-02 was safe and well-tolerated. ClinicalTrials.gov: NCT02280629, NCT02142725.
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ISSN:1542-3565
1542-7714
DOI:10.1016/j.cgh.2023.09.031