Mirikizumab Demonstrates Clinically Meaningful Improvements in Chinese Subpopulations of Phase 3 IBD Trials
Eli Lilly
Global Pharmaceutical R&D and Production Company
In the Chinese subgroup of the Phase 3 clinical trial LUCENT-1/2 study, patients with moderate to severe active ulcerative colitis who received mirikizumab treatment showed numerically higher clinical remission rates in both the induction and maintenance phases compared to the placebo group.
Patients with moderately to severely active Crohn's disease who received mirikizumab treatment achieved clinically meaningful improvements in both co-primary endpoints and all key secondary endpoints compared to placebo; a higher proportion of patients achieved endoscopic response and CDAI clinical remission at week 52 compared to those treated with ustekinumab.
In the Chinese subgroup of the Phase 3 clinical trials LUCENT-1/2 and VIVID-1, the incidence of adverse events during the treatment period was similar across all treatment groups. Compared with the placebo group, patients in the mirikizumab group experienced fewer serious adverse events and adverse events leading to discontinuation.
Statement:
1. The drugs and related indications described in this article have not been approved in mainland China.
2. Eli Lilly does not recommend the use of any unapproved drugs and/or unapproved indications.
On October 25, 2025, Eli Lilly China disclosed multiple Phase 3 clinical trial data of mirikizumab in ulcerative colitis (UC) and Crohn’s disease (CD) at the 25th Annual Meeting of the Chinese Society of Gastroenterology (China Gastroenterology Conference, CGC).1。
Mirikizumab is an IgG4-type monoclonal antibody that specifically targets the p19 subunit of interleukin-23 (IL-23), selectively inhibiting the IL-23 pathway and modulating immune-inflammatory responses driven by it. Eli Lilly and Company previously reported global Phase 3 efficacy data for mirikizumab in moderate to severe active ulcerative colitis in 2023 and in Crohn's disease in 2024. Mirikizumab demonstrated significantly greater clinical and endoscopic outcome improvements compared to placebo at Week 12 of the induction phase and Week 40 of the maintenance phase, with good tolerability.2-3. This drug became the world's first approved IL-23p19 inhibitor for the treatment of moderate to severe active UC in 2023. It has already been approved in the United States, the European Union, Japan, and other countries/regions for treating adult patients with moderate to severe active UC and CD, and is currently under review by China's National Medical Products Administration.4。
Senior Vice President of Eli Lilly and Company
Eli Lilly and Company China Drug Development andHead of Medical Affairs Center
Dr. Wang Li
Inflammatory bowel disease is a condition with a prolonged course that significantly impacts quality of life, especially for patients who do not respond well to existing treatments, making it urgent to develop more precise and efficient therapeutic options. We are very pleased to see that the results of the LUCENT and VIVID China subgroups are consistent with the global studies. This outcome further supports the potential value of mirikizumab for Chinese patients with inflammatory bowel disease. We look forward to the approval of mirikizumab in China as soon as possible, providing more patients with a new treatment option that features an innovative mechanism and good tolerability.
In the LUCENT-1 study, a total of 184 Chinese adult patients with moderate to severe active UC were enrolled. At week 12, the clinical remission rate in the mirikizumab group was higher than that in the placebo group. Among Chinese patients who responded to mirikizumab induction therapy, 50.0% achieved clinical remission at week 52 during the maintenance treatment period, demonstrating clinically meaningful improvement consistent with the overall population in LUCENT-2.
In Chinese patients, the incidence of adverse events during treatment was similar across all treatment groups. Compared with the placebo group, patients in the mirikizumab group experienced fewer serious adverse events and adverse events leading to discontinuation.
In the VIVID-1 study, a total of 152 Chinese adult patients with moderate to severe active CD were enrolled. Consistent with the global population, in the China subgroup of VIVID-1, the mirikizumab group achieved clinically meaningful improvements in both co-primary endpoints and all key secondary endpoints compared to the placebo group. Compared to patients treated with ustekinumab, a higher proportion of patients treated with mirikizumab achieved endoscopic response at week 52 (49.4% vs 27.5%), CDAI clinical remission (48.2% vs 20.0%), and both CDAI clinical remission and endoscopic response (32.5% vs 10.0%), demonstrating consistent and robust clinically significant improvement in line with the overall population.
In the Chinese population, the exposure-adjusted incidence rates of treatment-emergent adverse events (TEAEs), serious adverse events, and adverse events leading to study discontinuation were lower in the mirikizumab group than in the placebo group. The majority of TEAEs in the Chinese population were mild to moderate in severity.
About the LUCENT Series Research Project
The LUCENT series of studies are Phase 3 clinical trials exploring the efficacy and safety of mirikizumab in adults with moderate to severe UC, which were initiated in 2018 and include LUCENT-1, LUCENT-2, and LUCENT-3. The overall population results from the induction period of LUCENT-1 and the maintenance period of LUCENT-2 were officially published in The New England Journal of Medicine in 2023.2, 2-year and 3-year data from the open-label extension study LUCENT-3 were successively published in Inflammatory Bowel Diseases in 2024 and 2025.5,6。
About the VIVID Series Research Project
The VIVID series of studies are Phase 3 clinical trials exploring the efficacy and safety of mirikizumab in adults with moderate to severe CD. Key data from the overall population of the 52-week VIVID-1 study were officially published in The Lancet in 2024.3, 2-year results of the open-label extension study VIVID-2 disclosed at the 2025 American Digestive Disease Conference7。
References
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Eli Lilly and Company is a pharmaceutical company dedicated to improving human health through scientific innovation and benefiting patients worldwide. As a leader in the healthcare industry, Eli Lilly and Company has nearly 150 years of history. Today, our medicines have helped tens of millions of people around the world. Harnessing the power of biotechnology, chemistry, and genetic medicine, our scientists are actively advancing new medical breakthroughs to address severe global health challenges. Redefining therapies for diabetes and obesity, reducing the long-term impact of obesity on the body; supporting prevention and treatment efforts for Alzheimer's disease; providing solutions for a range of immune diseases that threaten human health; and transforming difficult-to-treat cancers into manageable conditions. Every step Eli Lilly and Company takes toward a healthier world stems from our belief in "committing to making life better for millions of patients." This includes innovative clinical trials aimed at addressing multiple global challenges, while ensuring the accessibility and affordability of medicines. For more information about Eli Lilly and Company, please visit: www.lilly.com.cn.
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