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

Abstract: 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

Angaben zum Objekt

• Standort: Deutsche Nationalbibliothek Frankfurt am Main
• Umfang: Online-Ressource
• Sprache: Englisch
• Anmerkungen: Clinical gastroenterology and hepatology. - 22, 4 (2024) , 810-820.e7, ISSN: 1542-7714

Beteiligte, Orts- und Zeitangaben

• Ereignis: Veröffentlichung
• (wo): Freiburg
• (wer): Universität
• (wann): 2023
• Urheber: Dignaß, Axel Uwe ; Stremmel, Wolfgang ; Horyński, Marek ; Poyda, Oleksandr ; Armerding, Peter ; Fellermann, Klaus ; Langhorst, Jost ; Kuehbacher, Tanja ; Uebel, Peter ; Stein, Jürgen ; Novacek, Gottfried ; Avalueva, Elena ; Oleynik, Oleksandr ; Hasselblatt, Peter ; Dorofeyev, Andrey ; Heinemann, Heidrun ; Mueller, Ralph ; Greinwald, Roland ; Reinisch, Walter

Weitere Informationen

• DOI: 10.1016/j.cgh.2023.09.031
• URN: urn:nbn:de:bsz:25-freidok-2404280
• Rechteinformation: Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
• Letzte Aktualisierung: 25.03.2025, 13:47 MEZ