Treatment with mirikizumab, an investigational anti-IL-23p19 monoclonal antibody, led to clinical remission and an improvement in symptoms in patients with moderate to severe ulcerative colitis (UC), according to data from a phase 3 trial.
LUCENT-1 (ClinicalTrials.gov: NCT03518086) is a 12-week, double-blind, placebo-controlled induction study evaluating the efficacy and safety of mirikizumab in over 1100 UC patients who had an inadequate response to, loss of response, or were intolerant to conventional or biologic therapy for UC. Patients were randomly assigned to receive mirikizumab or placebo intravenously; the primary endpoint was clinical remission based on modified Mayo Score at week 12.
Results showed that mirikizumab met both the primary (P <.0001) and key secondary endpoints (reduced bowel urgency; clinical response; endoscopic remission, symptomatic remission, improvement in endoscopic histologic inflammation) when compared with placebo. Improvement in symptoms was noted as early as 4 weeks and was also reported among patients who had previously not responded to or who were no longer responding to biologic and/or Janus kinase inhibitor therapies. The most common adverse events reported in the study included nasopharyngitis, anemia, and headache.
“Results of this study provide further clinical evidence of the potential for mirikizumab to become the first anti-IL-23p19 biologic for the treatment of ulcerative colitis,” said William J. Sandborn, MD, Professor of Medicine, and Chief, Division of Gastroenterology, University of California San Diego.
Mirikizumab is also being evaluated in the LUCENT-2 trial (ClinicalTrials.gov: NCT03524092), a multicenter, randomized, double-blind, placebo-controlled maintenance study in patients who have completed the 12-week LUCENT-1 induction study, and in LUCENT-3 (ClinicalTrials.gov: NCT03519945), an open-label extension study for eligible patients who have participated in the mirikizumab UC clinical development program.
Full results from the induction and maintenance studies are expected in early 2022.
Lilly’s mirikizumab helps patients achieve clinical remission and improves symptoms in adults with ulcerative colitis in 12-week phase 3 induction study. [press release]. Indianapolis, IN: Eli Lily; March 16, 2021.