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Lilly's Mirikizumab Helps Patients Achieve Clinical Remission and Improves Symptoms in Adults with Ulcerative Colitis in 12-Week Phase 3 Induction Study

Published: 2021-03-16 10:45:00 ET
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- Patients treated with mirikizumab met the primary endpoint of clinical remission and all key secondary endpoints compared to placebo

- LUCENT-1 is the first and only Phase 3 study of an anti-IL-23p19 monoclonal antibody to demonstrate reduced bowel urgency in moderate to severe ulcerative colitis

- Safety results in this study were consistent with that of the previous mirikizumab study in ulcerative colitis and studies with the anti-IL-23p19 antibody class

INDIANAPOLIS, March 16, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that mirikizumab met the primary and all key secondary endpoints in LUCENT-1, a 12-week Phase 3 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.

UC is a chronic inflammatory disease of the large intestine, also referred to as the colon, that affects the lining of the colon and may cause small sores, or ulcers, to form.i This inflammation can cause abdominal pain, frequent and urgent trips to the bathroom, bloody stools and incontinence.1 UC can cause significant and debilitating disruptions in daily life. Millions of people live with UC globally.2

"There is a continued need for additional treatments that can provide people living with ulcerative colitis relief from their most challenging symptoms," said William J. Sandborn, MD, Professor of Medicine, and Chief, Division of Gastroenterology, University of California San Diego. "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."

In LUCENT-1, mirikizumab met the primary endpoint of clinical remission at Week 12 compared to placebo (p