Anti-TL1A Antibody PF-06480605 safety and efficacy for ulcerative colitis: A phase 2a single-arm study
Clinical Gastroenterology and Hepatology Jun 17, 2021
Danese S, Klopocka M, Scherl EJ, et al. - A Phase 2a, multicenter, single-arm, open-label study was conducted to assess safety, tolerability, efficacy, pharmacokinetics, and immunogenicity in PF-06480605-treated participants with moderate-to-severe ulcerative colitis (UC). Researchers administered 500 mg intravenous PF-06480605 every 2 weeks, 7 doses total, with a 3-month follow-up period. The research recruited 50 individuals; 42 completed. The findings suggested that in participants with moderate-to-severe UC, PF-06480605 demonstrated an acceptable safety profile and statistically significant EI, warranting further study in a larger participant cohort. This conclusion was supported by tissue histopathology analyses.
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