A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease

Summary

The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn's Disease.

Timeline

Start

2016-12-14

Primary completion

2018-12-11

Completion

2021-02-05

Outcome

Met primary endpoint

registry Placebo IV Q4W vs 600 mg Mirikizumab IV Q4W; p = 0.003; Odds Ratio (OR) 4.92 (90% CI 2.01 to 12.07) NCT02891226 ↗

registry Placebo IV Q4W vs 1000 mg Mirikizumab IV Q4W; p <0.001; Odds Ratio (OR) 6.14 (90% CI 2.81 to 13.42) NCT02891226 ↗

Publications

• Jairath V, Hunter Gibble T, Peyrin-Biroulet L, Sands BE, Hirai F, Hibi T, Loftus EV Jr, Cross RK, Protic M, Chan LS, Morris N, Traxler K, Rubin DT. Impact of mirikizumab on patient-reported outcomes and quality of life in patients with Crohn's disease: results from the phase 2 SERENITY study. Crohns Colitis 360. 2026 Mar 11;8(1):otag018. doi: 10.1093/crocol/otag018. eCollection 2026 Jan.
• Magro F, Protic M, De Hertogh G, Chan LS, Pollack P, Jairath V, Carlier H, Hon E, Feagan BG, Harpaz N, Pai R, Reinisch W. Effects of Mirikizumab on Histologic Resolution of Crohn's Disease in a Randomized Controlled Phase 2 Trial. Clin Gastroenterol Hepatol. 2024 Sep;22(9):1878-1888.e10. doi: 10.1016/j.cgh.2023.11.010. Epub 2023 Nov 20.
• Sands BE, Peyrin-Biroulet L, Kierkus J, Higgins PDR, Fischer M, Jairath V, Hirai F, D'Haens G, Belin RM, Miller D, Gomez-Valderas E, Naegeli AN, Tuttle JL, Pollack PF, Sandborn WJ. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn's Disease. Gastroenterology. 2022 Feb;162(2):495-508. doi: 10.1053/j.gastro.2021.10.050. Epub 2021 Nov 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirikizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Mirikizumab	Monoclonal antibody	300 mg	Intravenous
Subject	Mirikizumab	Monoclonal antibody	600 mg	Intravenous
Subject	Mirikizumab	Monoclonal antibody	1000 mg	Intravenous

Indications