A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Summary

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

Timeline

Start

2022-09-13

Primary completion

2024-04-02

Completion

2028-10-06

Publications

• Long M, Allegretti JR, Danese S, Germinaro M, Baker T, Alvarez Y, Kavalam M, Han C, Jorgens S, Jiang L, Zhang H, Hisamatsu T, Rubin DT, Peyrin-Biroulet L; ASTRO Study Group. Efficacy and safety of subcutaneous guselkumab induction therapy in participants with moderately to severely active ulcerative colitis (ASTRO): a double-blind, treat-through, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2026 Apr;11(4):284-298. doi: 10.1016/S2468-1253(25)00322-X. Epub 2026 Jan 13.

Drugs

Indications