2 weeks Ago By Kim Min-jee
On April 24, Celltrion announced that the results of the long-term global Phase 3 clinical study of its autoimmune disease treatment, ‘CT-P13 SC’ (subcutaneous infliximab, known as Zymfentra in the U.S.), were published in the international journal, the Journal of Crohn's and Colitis.
This journal is the official publication of the European Crohn's and Colitis Organisation (ECCO) and is highly influential in the fields of gastroenterology and inflammatory bowel diseases (IBD). Through this publication, Celltrion presented the findings of a study that maintained treatment with CT-P13 SC over 102 weeks (approximately two years). The Phase 3 study was designed as an open-label trial involving 278 Crohn's disease patients and 348 ulcerative colitis patients.
The study evaluated the overall long-term treatment effects, including efficacy, safety, pharmacokinetics, and pharmacodynamics based on existing 54-week clinical data. Initially, CT-P13 was administered intravenously (IV) for the first 6 weeks. Patients who showed a treatment response were randomly assigned to receive either CT-P13 SC 120mg or a placebo starting at week 10, and the treatment continued until week 54.
Patients requiring intensified treatment after week 22 could have their dose increased to 240mg. Those who participated in the extension study continued with the CT-P13 SC monotherapy through week 102. The study results indicated that CT-P13 SC maintained stable efficacy, safety, and tolerability over long-term administration, showing positive outcomes in pharmacokinetics and pharmacodynamics.
Significant treatment effects were observed in key indicators such as clinical remission and endoscopic response, and no new safety concerns arose even in the dose-escalated group. “This study further substantiates the sustained treatment efficacy and long-term prescription viability of CT-P13 SC, which is expected to support its expanded prescription in the U.S,” said an official from Celltrion.
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