A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis

Summary

This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.

Timeline

Start

2019-12-19

Primary completion

2022-10-25

Completion

2022-10-25

Publications

• Danese S, Allegretti JR, Schreiber S, Peyrin-Biroulet L, Jairath V, D'Haens G, Kierkus J, Leong RW, Yarur AJ, Vincent MS, Banerjee A, Chandra DE, Peeva E, Neelakantan S, Hung KE, McBride JM, Bojic D, Lasch K, Schiffman C, Feagan BG. Anti-TL1A antibody, afimkibart, in moderately-to-severely active ulcerative colitis (TUSCANY-2): a multicentre, double-blind, treat-through, multi-dose, randomised, placebo-controlled, phase 2b trial. Lancet Gastroenterol Hepatol. 2025 Oct;10(10):882-895. doi: 10.1016/S2468-1253(25)00129-3. Epub 2025 Jul 21.

Drugs

Indications