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

2027-07-16

Outcome

Met primary endpoint

registry p < 0.001; Adjusted treatment difference 33.6 (95% CI 20.9 to 46.3); Cochran-Mantel-Haenszel (CMH) chi-square NCT04033445 ↗

registry p < 0.001; Adjusted treatment difference 14.9 (95% CI 9.9 to 19.9); CMH chi-square test NCT04033445 ↗

registry p < 0.001; Adjusted treatment difference 25.2 (95% CI 16.4 to 33.9); Cochran-Mantel-Haenszel NCT04033445 ↗

release “compared with 27.6 percent (29/105) randomized to placebo (p<0.001).” jnj.com ↗

release “In the Phase 3 QUASAR induction and maintenance studies, guselkumab achieved each primary endpoint” jnj.com ↗

release “TREMFYA® (guselkumab) QUASAR Maintenance Study in UC met its primary endpoint” jnj.com ↗

release “TREMFYA (guselkumab) QUASAR Maintenance Study in UC met its primary endpoint and all major secondary endpoints” jnj.com ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	Guselkumab	Monoclonal antibody	100 mg	Intravenous
Subject	Guselkumab	Monoclonal antibody	200 mg	Intravenous
Subject	Guselkumab	Monoclonal antibody	400 mg	Intravenous

Indications