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Can mirikizumab be used for the first-line treatment of ulcerative colitis?
The safety and efficacy of mirikizumab for the first-line treatment of ulcerative colitis have not been evaluated.
Phase 3 Studies of Mirikizumab in Patients With Ulcerative Colitis
The safety and efficacy of mirikizumab, a p19-directed anti-IL-23 antibody, are being evaluated in adult patients with moderate-to-severe active ulcerative colitis in the phase 3 studies LUCENT-1, LUCENT-2, and LUCENT-3.1-3
To participate in the phase 3 clinical studies of mirikizumab for the treatment of moderately-to-severely active ulcerative colitis, patients must have had an inadequate response, loss of response, or an intolerance to corticosteroids, immunosuppressants, biologic therapies, or tofacitinib.4
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1An induction study of mirikizumab in participants with moderately to severely active ulcerative colitis (LUCENT-1). ClinicalTrials.gov identifier: NCT03518086. Updated February 28, 2022. Accessed September 15, 2022. https://clinicaltrials.gov/show/NCT03518086
2A maintenance study of mirikizumab in participants with moderately to severely active ulcerative colitis (LUCENT-2). ClinicalTrials.gov identifier: NCT03524092. Updated September 10, 2022. Accessed September 15, 2022. https://clinicaltrials.gov/show/NCT03524092
3A study to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (LUCENT-3). ClinicalTrials.gov identifier: NCT03519945. Updated September 9, 2022. Accessed September 15, 2022. https://clinicaltrials.gov/show/NCT03519945
4D'Haens G, Kobayashi T, Morris N, et al. Efficacy and safety of mirikizumab as induction therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 LUCENT-1 study. J Crohns Colitis. 2022;16(suppl 1):i028-i029. European Crohn's and Colitis Organisation abstract OP26. https://doi.org/10.1093/ecco-jcc/jjab232.025
Date of Last Review: October 11, 2022