Mirikizumab (LUCENT1 Study)
Architecture
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Global Phase III registrational program evaluating mirikizumab, an anti-IL-23 monoclonal antibody, for moderate-to-severe ulcerative colitis and Crohn’s disease.
Location
Global
Category
Hudson Yards, New York
Year
2024
Mirikizumab’s LUCENT1 study has been a cornerstone in advancing IL-23 targeted therapies for inflammatory bowel diseases. Conducted globally, the Phase III trials enrolled thousands of patients with moderate-to-severe ulcerative colitis, including those refractory to corticosteroids, immunomodulators, or tumor necrosis factor inhibitors. The drug operates by selectively inhibiting IL-23, a cytokine critical in maintaining chronic inflammation and mucosal immune dysregulation.
Patients were treated with induction and maintenance dosing regimens, with endpoints encompassing clinical remission, endoscopic healing, and sustained response over 52 weeks. Mirikizumab demonstrated statistically significant improvements across all primary and secondary outcomes compared to placebo. Importantly, the therapy was associated with rapid symptom relief and a durable mucosal healing effect, translating into improved patient quality of life and reduced need for corticosteroids.
Safety assessments affirmed a well-tolerated profile, with infections being the most common adverse events but occurring at rates comparable to placebo. The drug’s immunomodulatory action did not significantly increase serious infection or malignancy risks, important considerations for long-term therapy in chronic autoimmune disease. FDA approval for ulcerative colitis was granted in late 2023, and the label was expanded to include Crohn’s disease in early 2025, marking a significant milestone in the therapeutic landscape.
Beyond clinical outcomes, extensive biomarker studies have linked response to mirikizumab with reductions in IL-23 pathway gene expression and inflammatory markers in tissue and blood samples. These insights facilitate precision medicine approaches, tailoring treatment to patients most likely to benefit. Mirikizumab offers an oral-biologic alternative, appealing to patients seeking effective yet convenient options in chronic IBD management.
