Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis

Summary

The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).

Timeline

Start

2016-11-14

Primary completion

2020-03-31

Completion

2020-03-31

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry Induction Study (Cohort A): Filgotinib 200 mg vs Induction Study (Cohort A): Placebo; p = 0.0157; Difference in Percentages 10.8 (95% CI 2.1 to 19.5) reads as mixed primary results NCT02914522 ↗

registry Induction Study (Cohort A): Filgotinib 100 mg vs Induction Study (Cohort A): Placebo; p = 0.3379; Difference in Percentages 3.8 (95% CI -4.3 to 12.0) reads as mixed primary results NCT02914522 ↗

registry Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg vs Maintenance Study: Placebo From Induction Filgotinib 200 mg; p < 0.0001; Difference in Percentages 26.0 (95% CI 16.0 to 35.9) reads as mixed primary results NCT02914522 ↗

registry Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg vs Maintenance Study: Placebo From Induction Filgotinib 100 mg; p = 0.0420; Difference in Percentages 10.4 (95% CI -0.0 to 20.7) reads as mixed primary results NCT02914522 ↗

release “Filgotinib 200 mg Demonstrated Greater Efficacy Compared with Placebo in the Induction and Maintenance of Remission in the SELECTION Trial” reads as mixed primary results gilead.com ↗

release “Filgotinib 200 mg achieved all primary endpoints in the study, inducing clinical remission at Week 10 and maintaining clinical remission at Week 58” reads as mixed primary results gilead.com ↗

release “Filgotinib 100 mg did not achieve statistically significant clinical remission at Week 10.” reads as mixed primary results gilead.com ↗

release “The SELECTION trial demonstrated that a statistically significantly higher proportion of patients treated with filgotinib 200 mg versus placebo achieved clinical remission at week 10” reads as met primary endpoint gilead.com ↗

Publications

• Magro F, Rogler G, Feagan BG, Peyrin-Biroulet L, Oortwijn A, Cougnaud L, Faes M, Bauer Y, Randall M, Rudolph C, Reinisch W. Association between endo-histological outcomes and colonic mucosal transcriptomic profiles in patients with ulcerative colitis receiving filgotinib. J Crohns Colitis. 2026 Feb 5;20(2):jjaf228. doi: 10.1093/ecco-jcc/jjaf228.
• Louis E, Schreiber S, Hisamatsu T, Hibi T, Jamoul C, Muller K, Taliadouros V, Oortwijn A, Peyrin-Biroulet L, Feagan BG. Factors associated with response to filgotinib and the prognostic power of faecal calprotectin for ulcerative colitis in the phase 2b/3 SELECTION trial. Dig Liver Dis. 2025 Jul;57(7):1411-1418. doi: 10.1016/j.dld.2025.04.036. Epub 2025 May 15.
• Nakase H, Danese S, Reinisch W, Ritter T, Liang Y, Wendt E, Levesque BG, Yoon OK, Tian Y, Zhuo L, Karouzakis E, Bauer Y, Oortwijn A, Kaise T, Malkov VA, Hibi T. Mediators of Filgotinib Treatment Effects in Ulcerative Colitis: Exploring Circulating Biomarkers in the Phase 2b/3 SELECTION Study. Inflamm Bowel Dis. 2025 Apr 10;31(4):1095-1108. doi: 10.1093/ibd/izae278.
• Schreiber S, Feagan BG, Louis E, Hisamatsu T, Hibi T, Dron L, Jamoul C, Patel H, Harris K, Taliadouros V, Oortwijn A, Peyrin-Biroulet L. Distinct trajectories of symptomatic response in ulcerative colitis during filgotinib therapy: A post hoc analysis from the SELECTION study. United European Gastroenterol J. 2024 Nov;12(9):1243-1255. doi: 10.1002/ueg2.12686. Epub 2024 Oct 25.
• Watanabe K, Peyrin-Biroulet L, Danese S, Fujitani Y, Faes M, Oortwijn A, Lindsay JO, Rogler G, Hibi T. Impact of Concomitant Thiopurine on the Efficacy and Safety of Filgotinib in Patients with Ulcerative Colitis: Post Hoc Analysis of the Phase 2b/3 SELECTION Study. J Crohns Colitis. 2024 Jun 3;18(6):801-811. doi: 10.1093/ecco-jcc/jjad201.
• Schreiber S, Rogler G, Watanabe M, Vermeire S, Maaser C, Danese S, Faes M, Van Hoek P, Hsieh J, Moerch U, Zhou Y, de Haas A, Rudolph C, Oortwijn A, Loftus EV Jr. Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE. Aliment Pharmacol Ther. 2023 Nov;58(9):874-887. doi: 10.1111/apt.17674. Epub 2023 Sep 18.
• Vermeire S, Feagan BG, Peyrin-Biroulet L, Oortwijn A, Faes M, de Haas A, Rogler G. Withdrawal and Re-treatment with Filgotinib in Ulcerative Colitis: Post Hoc Analyses of the Phase 2b/3 SELECTION and SELECTIONLTE Studies. J Crohns Colitis. 2024 Jan 27;18(1):54-64. doi: 10.1093/ecco-jcc/jjad123.
• Lu X, Zhou ZY, Xin Y, Wang MJ, Gray E, Jairath V, Lindsay JO. Matching-Adjusted Indirect Comparisons of Filgotinib vs Vedolizumab, Tofacitinib, and Ustekinumab for Moderately to Severely Active Ulcerative Colitis. Inflamm Bowel Dis. 2024 Jan 5;30(1):64-77. doi: 10.1093/ibd/izad037.
• Dotan I, Feagan BG, Taliadouros V, Oortwijn A, Rudolph C, de Haas A, Santermans E, Hsieh J, Peyrin-Biroulet L, Hibi T. Efficacy of Filgotinib in Patients with Ulcerative Colitis by Line of Therapy in the Phase 2b/3 SELECTION Trial. J Crohns Colitis. 2023 Aug 21;17(8):1207-1216. doi: 10.1093/ecco-jcc/jjad039.
• Schreiber S, Feagan BG, Peyrin-Biroulet L, Vermeire S, Faes M, Harris K, Oortwijn A, Daniele P, Patel H, Danese S. Filgotinib Improved Health-Related Quality of Life and Led to Comprehensive Disease Control in Individuals with Ulcerative Colitis: Data from the SELECTION Trial. J Crohns Colitis. 2023 Jun 16;17(6):863-875. doi: 10.1093/ecco-jcc/jjad018.
• Loftus EV, Vermeire S, Feagan BG, Le Brun FO, Oortwijn A, Moerch U, Sandborn WJ, Hibi T. Corticosteroid-Sparing Effects of Filgotinib in Moderately to Severely Active Ulcerative Colitis: Data from the Phase 2b/3 SELECTION Study. J Crohns Colitis. 2023 Mar 18;17(2):211-220. doi: 10.1093/ecco-jcc/jjac122.
• Feagan BG, Danese S, Loftus EV Jr, Vermeire S, Schreiber S, Ritter T, Fogel R, Mehta R, Nijhawan S, Kempinski R, Filip R, Hospodarskyy I, Seidler U, Seibold F, Beales ILP, Kim HJ, McNally J, Yun C, Zhao S, Liu X, Hsueh CH, Tasset C, Besuyen R, Watanabe M, Sandborn WJ, Rogler G, Hibi T, Peyrin-Biroulet L. Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial. Lancet. 2021 Jun 19;397(10292):2372-2384. doi: 10.1016/S0140-6736(21)00666-8. Epub 2021 Jun 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Filgotinib	Small molecule	100 mg	Oral
Subject	Filgotinib	Small molecule	200 mg	Oral

Indications