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Modified-release phosphatidylcholine (LT-02) for ulcerative colitis: two double-blind, randomized, placebo-controlled trials

Background & Aims - 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. - Methods -...

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Main Authors: Dignaß, Axel Uwe (Author) , Stremmel, Wolfgang (Author) , Horyński, Marek (Author) , Poyda, Oleksandr (Author) , Armerding, Peter (Author) , Fellermann, Klaus (Author) , Langhorst, Jost (Author) , Kuehbacher, Tanja (Author) , Uebel, Peter (Author) , Stein, Jürgen (Author) , Novacek, Gottfried (Author) , Avalueva, Elena (Author) , Olijnyk, Oleksandr Ljeontijovyč (Author) , Hasselblatt, Peter (Author) , Dorofeyev, Andrey (Author) , Heinemann, Heidrun (Author) , Mueller, Ralph (Author) , Greinwald, Roland (Author) , Reinisch, Walter (Author)
Format: Article (Journal)
Language:English
Published: April 2024
In: Clinical gastroenterology and hepatology
Year: 2024, Volume: 22, Issue: 4, Pages: 810-820
ISSN:1542-7714
DOI:10.1016/j.cgh.2023.09.031
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.cgh.2023.09.031
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S1542356523007711
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Author Notes:Axel Dignass, Wolfgang Stremmel, Marek Horyński, Oleksandr Poyda, Peter Armerding, Klaus Fellermann, Jost Langhorst, Tanja Kuehbacher, Peter Uebel, Juergen Stein, Gottfried Novacek, Elena Avalueva, Oleksandr Oliinyk, Peter Hasselblatt, Andrey Dorofeyev, Heidrun Heinemann, Ralph Mueller, Roland Greinwald and Walter Reinisch
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Summary:Background & Aims - 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. - Methods - 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. - Results - 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. - Conclusions - 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.
Item Description:Gesehen am 02.12.2024
Physical Description:Online Resource
ISSN:1542-7714
DOI:10.1016/j.cgh.2023.09.031

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