VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

Summary

This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (UC). Approximately 189 participants will take VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily. The study consists of a 28-day Screening Period (to see if a participant qualifies for the study), a 13-week double-blind period (a participant receives either active Dose A, Dose B or Placebo), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.

Timeline

Start

2021-11-30

Primary completion

2023-08-30

Completion

2025-03-13

Publications

• Sands BE, Panaccione R, D'Haens G, Schreiber S, Jairath V, DuVall A, Kierkus J, Walczak M, Naik S, Gilder K, Lindstrom B, Ogilvie K, Sandborn WJ, Vermeire S, Rubin DT, Peyrin-Biroulet L, Danese S. Tamuzimod in patients with moderately-to-severely active ulcerative colitis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 induction trial. Lancet Gastroenterol Hepatol. 2025 Mar;10(3):210-221. doi: 10.1016/S2468-1253(24)00386-8. Epub 2025 Jan 7.

Drugs

Indications