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

Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Timeline

Start

2019-09-26

Primary completion

2023-09-19

Completion

2027-09-29

Publications

• Lichtenstein GR, Allegretti JR, Rubin DT, Magro F, Bressler B, Panes J, Afif W, Samaan MA, Ye BD, Yarandi S, Germinaro M, Shipitofsky N, Miao Y, Zhang H, Dignass A, Sands BE, Hisamatsu T, Peyrin-Biroulet L. Efficacy and Safety of Guselkumab for Ulcerative Colitis Through Week 92 of the QUASAR Long-Term Extension Study. Am J Gastroenterol. 2026 May 1. doi: 10.14309/ajg.0000000000004041. Online ahead of print.
• Hart A, Sridhar S, Venkat S, Lee T, Rusbuldt JJ, Richards D, Sisk C, Horowitz D, Tomsho L, Kannan AK, Ruane D, Van den Berge K, Rubin DT, Sands BE, De Hertogh G, Huang KG, Germinaro M, Cua D, Waterworth D, Freeman TC, Vetter ML, McRae B, Verstockt B, Branigan P. Multiomic characterisation of the clinical efficacy of guselkumab induction therapy in ulcerative colitis. BMJ Open Gastroenterol. 2026 Mar 23;13(1):e002153. doi: 10.1136/bmjgast-2025-002153.
• Chen B, Ye BD, Cao Q, Hirai F, Saruta M, Chen M, Pelak S, Shipitofsky N, Miao Y, Herr K, Wahking B, Zhuo J, Hisamatsu T. Guselkumab in East Asians With Moderate-to-Severe Ulcerative Colitis: Subgroup Analysis of the QUASAR Induction and Maintenance Studies. J Gastroenterol Hepatol. 2025 Sep;40(9):2197-2208. doi: 10.1111/jgh.17036. Epub 2025 Jun 26.
• Rubin DT, Allegretti JR, Panes J, Shipitofsky N, Yarandi SS, Huang KG, Germinaro M, Wilson R, Zhang H, Johanns J, Feagan BG, Hisamatsu T, Lichtenstein GR, Bressler B, Peyrin-Biroulet L, Sands BE, Dignass A; QUASAR Study Group. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies. Lancet. 2025 Jan 4;405(10472):33-49. doi: 10.1016/S0140-6736(24)01927-5. Epub 2024 Dec 17.
• Peyrin-Biroulet L, Allegretti JR, Rubin DT, Bressler B, Germinaro M, Huang KG, Shipitofsky N, Zhang H, Wilson R, Han C, Feagan BG, Sandborn WJ, Panes J, Hisamatsu T, Lichtenstein GR, Sands BE, Dignass A; QUASAR Study Group. Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study. Gastroenterology. 2023 Dec;165(6):1443-1457. doi: 10.1053/j.gastro.2023.08.038. Epub 2023 Sep 1.

Drugs

Indications