Mirikizumab met the primary and all key secondary endpoints in LUCENT-1, phase III induction study to evaluate the efficacy and safety of mirikizumab for moderate to severe ulcerative colitis .

Eli Lilly and Company has announced that mirikizumab met the primary and all key secondary endpoints in LUCENT-1, a 12-week Phase III induction study evaluating the efficacy and safety of mirikizumab for the treatment of patients with moderate to severe ulcerative colitis (UC). LUCENT-2, a multicenter, randomized, double-blind, placebo-controlled maintenance study of mirikizumab in patients who have completed the 12-week LUCENT-1 induction study is ongoing. In LUCENT-1, mirikizumab met the primary endpoint of clinical remission at Week 12 compared to placebo (p<0.0001). clinical remission is met when inflammation of the colon is controlled or resolved, leading to normalization or near-normalization of symptoms such as stool frequency and bleeding.mirikizumab also achieved all key secondary endpoints compared to placebo at week 12 in patients with uc with highly statistically significant p-values, including reduced bowel urgency, clinical response, endoscopic remission, symptomatic remission and improvement in endoscopic histologic inflammation. in addition, mirikizumab demonstrated rapid improvement in patient symptoms as early as four weeks after initiating treatment. mirikizumab also reduced symptoms among patients who had previously not responded to or stopped responding to biologic and or janus kinase (jak) inhibitor therapies.| in the 12-week placebo-controlled induction study of lucent-1, the incidence of treatment-emergent adverse events (aes) and serious aes among patients treated with mirikizumab was consistent with that of the previous phase ii mirikizumab study in uc and studies with the anti-il-23p19 antibody class. the most common aes included nasopharyngitis, anemia and headache for both placebo and mirikizumab-treated patients. the full lucent study results, including data from lucent-2 and lucent-3, will be disclosed at a future congress or publication. about the lucent clinical trial program : the lucent phase iii clinical development program for mirikizumab includes lucent-1, lucent-2 and lucent-3. lucent-1 (nct03518086) is a multicenter, randomized, double-blind, placebo-controlled, phase iii induction study of mirikizumab in patients with moderate to severe uc who had failed conventional and or biologic treatments. lucent-2 (nct03524092) is a multicenter, randomized, double-blind, placebo-controlled maintenance study of mirikizumab in patients who have completed the 12-week lucent-1 induction study. lucent-3 (nct03519945) is an open label extension study for eligible patients who have participated in mirikizumab uc trials. the program began in 2018, with full results from the induction and maintenance studies anticipated in early 2022.>