drugset / Trial / NCT02891226
A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
RandomizedParallel-groupDouble-blindTreatment
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
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 |