A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Summary
The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
Timeline
- Start
- 2019-07-23
- Primary completion
- 2023-08-23
- Completion
- 2023-10-02
Outcome
Met primary endpoint
paper Both coprimary endpoints were met: PMID 39581202 ↗
paper CDAI clinical remission-composite was reached in 263 (45·4%) of 579 patients on mirikizumab versus 39 (19·6%) of 199 patients on placebo (99·5% CI 15·9-35·6; p<0·0001). PMID 39581202 ↗
release “mirikizumab (an investigational interleukin-23p19 antagonist) met the co-primary and all major secondary endpoints compared to placebo in VIVID-1” lilly.com ↗
release “In VIVID-1, patients treated with mirikizumab achieved statistically significant improvement compared to placebo-treated patients on both co-primary endpoints, composite endoscopic response and composite clinical remission” lilly.com ↗
Publications
- Jairath V, Magro F, Protic M, De Hertogh G, Harpaz N, Hisamatsu T, D'Haens G, Pai R, Yu G, Morris N, Luo WT, Hon E, Escobar R, Biedermann L, Reinisch W; VIVID Study Group. Histologic and combined histologic-endoscopic outcomes with mirikizumab in Crohn's disease: VIVID-1 trial results. J Crohns Colitis. 2026 Jun 7;20(6):jjag077. doi: 10.1093/ecco-jcc/jjag077.
- Jairath V, D'Haens G, Sands BE, Travis S, Chaparro M, Peyrin-Biroulet L, Chen MH, Dubinsky M, Ferrante M, Schreiber S, McGinnis K, Vadhariya A, Appelmans S, Lin Z, Yu G, Protic M, Moses R, Ghosh S. Bowel Urgency in Crohn's Disease: Effects of Mirikizumab in a Randomized Controlled Phase 3 Study. Clin Gastroenterol Hepatol. 2026 Feb;24(2):463-473.e5. doi: 10.1016/j.cgh.2025.07.003. Epub 2025 Jul 14.
- Regueiro M, Fischer M, Bossuyt P, Protic M, Traxler K, Yu G, Zang H, Vadhariya A, Hisamatsu T, Juillerat P, Armuzzi A, Gisbert JP, Walsh A. Impact of mirikizumab treatment on fatigue in patients with moderately to severely active Crohn's disease: results from the phase 3 VIVID-1 study. J Crohns Colitis. 2025 Jul 3;19(7):jjaf100. doi: 10.1093/ecco-jcc/jjaf100.
- Lee SD, Vermeire S, Ungaro R, Vadhariya A, Durand F, Morris N, Yu G, Fisher DA, Traxler K, Long M. Mirikizumab Improves Quality of Life and Work Productivity in Patients with Moderately to Severely Active Crohn's Disease: Results from the Phase 3 VIVID-1 Study. Am J Gastroenterol. 2025 Mar 13;120(8):1809-1819. doi: 10.14309/ajg.0000000000003410.
- Lewis JD, Vadhariya A, Su S, Zhou X, Durand F, Kawata AK, Stassek L, Clucas C, Schreiber S. A patient-reported outcome measure comprising the stool frequency and abdominal pain items from the Crohn's Disease Activity Index: psychometric evaluation in adults with Crohn's disease. J Patient Rep Outcomes. 2025 Feb 17;9(1):19. doi: 10.1186/s41687-025-00851-y.
- Dubinsky M, Vadhariya A, Su S, Zhou X, Durand F, Clucas C, Stassek L, Kawata AK, Travis S. The Urgency Numeric Rating Scale: Psychometric Evaluation in Adults with Crohn's Disease. Adv Ther. 2025 Feb;42(2):1044-1060. doi: 10.1007/s12325-024-03081-8. Epub 2024 Dec 18.
- Ferrante M, D'Haens G, Jairath V, Danese S, Chen M, Ghosh S, Hisamatsu T, Kierkus J, Siegmund B, Bragg SM, Crandall W, Durand F, Hon E, Lin Z, Lopes MU, Morris N, Protic M, Carlier H, Sands BE; VIVID Study Group. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet. 2024 Dec 14;404(10470):2423-2436. doi: 10.1016/S0140-6736(24)01762-8. Epub 2024 Nov 21.
- Regueiro M, Su S, Vadhariya A, Zhou X, Durand F, Stassek L, Kawata AK, Clucas C, Jairath V. Psychometric evaluation of the Functional Assessment of chronic illness therapy-fatigue (FACIT-Fatigue) in adults with moderately to severely active Crohn's disease. Qual Life Res. 2025 Feb;34(2):509-521. doi: 10.1007/s11136-024-03829-3. Epub 2024 Nov 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirikizumab | Monoclonal antibody | 300 mg | Intravenous |
| Comparator | Ustekinumab | Monoclonal antibody | 90 mg | Intravenous |