A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis

Summary

The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (UC). This study will also investigate how the body processes the drug.

Timeline

Start

2015-12-09

Primary completion

2017-12-19

Completion

2019-05-07

Publications

• Friedrich S, Chua L, Adams DH, Crandall W, Zhang XC. Mirikizumab Exposure-Response Relationships in Patients with Moderately-to-Severely Active Ulcerative Colitis in Randomized Phase II and III Studies. Clin Pharmacol Ther. 2024 Aug;116(2):435-447. doi: 10.1002/cpt.3305. Epub 2024 May 26.
• Chua L, Friedrich S, Zhang XC. Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. Clin Pharmacokinet. 2023 Oct;62(10):1479-1491. doi: 10.1007/s40262-023-01281-z. Epub 2023 Aug 23.
• Johnson T, Steere B, Zhang P, Zang Y, Higgs R, Milch C, Reinisch W, Panes J, Huang K, D'Haens G, Krishnan V. Mirikizumab-Induced Transcriptome Changes in Ulcerative Colitis Patient Biopsies at Week 12 Are Maintained Through Week 52. Clin Transl Gastroenterol. 2023 Nov 1;14(11):e00630. doi: 10.14309/ctg.0000000000000630.
• Steere B, Schmitz J, Powell N, Higgs R, Gottlieb K, Liu Y, Jia B, Tuttle JL, Sandborn WJ, Sands BE, D'Haens G, Reinisch W, Krishnan V. Mirikizumab Regulates Genes Involved in Ulcerative Colitis Disease Activity and Anti-TNF Resistance: Results From a Phase 2 Study. Clin Transl Gastroenterol. 2023 Jul 1;14(7):e00578. doi: 10.14309/ctg.0000000000000578.
• Dubinsky MC, Panaccione R, Lewis JD, Sands BE, Hibi T, Lee SD, Naegeli AN, Shan M, Green LA, Morris N, Arora V, Bleakman AP, Belin R, Travis S. Impact of Bowel Urgency on Quality of Life and Clinical Outcomes in Patients With Ulcerative Colitis. Crohns Colitis 360. 2022 Jun 3;4(3):otac016. doi: 10.1093/crocol/otac016. eCollection 2022 Jul.
• Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Hibi T, D'Haens GR, Tuttle JL, Krueger K, Friedrich S, Durante M, Arora V, Naegeli AN, Schmitz J, Feagan BG. Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):105-115.e14. doi: 10.1016/j.cgh.2020.09.028. Epub 2020 Sep 18.
• Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Feagan BG, Hibi T, Tuttle JL, Klekotka P, Friedrich S, Durante M, Morgan-Cox M, Laskowski J, Schmitz J, D'Haens GR. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):537-549.e10. doi: 10.1053/j.gastro.2019.08.043. Epub 2019 Sep 4.

Drugs

Indications