Mirikizumab for Ulcerative Colitis
Recruiting in Palo Alto (17 mi)
+511 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Eli Lilly and Company
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing mirikizumab, a medication for people with severe ulcerative colitis. It aims to see if the drug can reduce gut inflammation by blocking a protein that causes it. The study will last several years. Mirikizumab has shown positive results in early tests for ulcerative colitis.
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications.
What safety data is available for Mirikizumab in treating ulcerative colitis?Mirikizumab, also known as Omvoh, is a humanized monoclonal antibody targeting IL-23p19, developed for ulcerative colitis and Crohn's disease. It was approved in Japan in March 2023 for moderate to severe ulcerative colitis. The safety and efficacy of Mirikizumab have been evaluated in several Phase 3 clinical trials, including LUCENT-1 and LUCENT-2, which were randomized, double-blind, placebo-controlled studies. These trials demonstrated its efficacy in improving quality of life and reducing bowel urgency in patients with moderately to severely active ulcerative colitis. Additionally, a Phase 2 trial also showed significant reduction in bowel urgency. While the abstracts provided focus on efficacy and quality of life improvements, they imply that safety data was collected as part of these trials, although specific safety outcomes are not detailed in the abstracts.23457
Is the drug Mirikizumab a promising treatment for ulcerative colitis?Yes, Mirikizumab is a promising drug for ulcerative colitis. It has been approved in Japan and received positive feedback in the EU for patients who don't respond well to other treatments. It has shown effectiveness in reducing symptoms like bowel urgency, which improves patients' quality of life.12356
What data supports the idea that Mirikizumab for Ulcerative Colitis is an effective drug?The available research shows that Mirikizumab is effective for treating ulcerative colitis. It was approved in Japan and received a positive opinion in the EU for patients who did not respond well to other treatments. Studies like the LUCENT-1 and LUCENT-2 trials demonstrated that Mirikizumab improved patients' quality of life and reduced symptoms like bowel urgency. These trials were carefully controlled to ensure reliable results, showing that Mirikizumab can help people with moderate to severe ulcerative colitis.24567
Eligibility Criteria
This trial is for people with moderate to severe ulcerative colitis who were previously in studies AMAC or AMBG and received at least one dose of the study drug without early termination. Women must agree to use contraception. Those with significant infections like hepatitis or HIV, recent UC surgery, new conditions such as cancer, or unremoved adenomatous polyps can't join.Inclusion Criteria
I agree to follow the study's birth control requirements.
I was in Study AMAC or AMBG, received at least one treatment, and did not stop the study drug early.
Exclusion Criteria
I do not have significant infections like hepatitis or HIV/AIDS.
I have not developed any new conditions, including cancer, since my original study.
I have had all adenomatous polyps removed before this study.
Participant Groups
The trial is testing Mirikizumab's long-term effectiveness and safety in treating ulcerative colitis. Participants are those who have already been part of earlier related trials and will continue to receive this medication over an extended period.
1Treatment groups
Experimental Treatment
Group I: MirikizumabExperimental Treatment1 Intervention
Mirikizumab administered subcutaneously (SC).
Mirikizumab is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Omvoh for:
- Moderately to severely active ulcerative colitis
🇺🇸 Approved in United States as Omvoh for:
- Moderately to severely active ulcerative colitis
🇨🇦 Approved in Canada as Omvoh for:
- Moderately to severely active ulcerative colitis
🇯🇵 Approved in Japan as Omvoh for:
- Moderately to severely active ulcerative colitis
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Om Research, LLCLancaster, CA
Lee Memorial HospitalGreat Neck, NY
Carolina Digestive DiseasesGreenville, NC
Care Access ResearchBerkeley, CA
More Trial Locations
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
References
Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. [2022]Mirikizumab is an antibody against the p19 subunit of interleukin 23 that has demonstrated clinical efficacy and was well tolerated following 12 weeks of induction treatment in a phase 2 trial of patients with moderate to severe ulcerative colitis. We present results of the open-label extended induction period in patients who did not initially respond to treatment with mirikizumab.
Clinical Effect of Mirikizumab Treatment on Bowel Urgency in Patients with Moderately to Severely Active Ulcerative Colitis and the Clinical Relevance of Bowel Urgency Improvement for Disease Remission. [2023]Bowel urgency reduces ulcerative colitis patients' quality of life. Mirikizumab, a p19-directed anti-IL-23 antibody, demonstrates ulcerative colitis efficacy. Mirikizumab efficacy to reduce bowel urgency and bowel urgency association with other endpoints were analyzed in 2 Phase 3 trials.
Impact of Bowel Urgency on Quality of Life and Clinical Outcomes in Patients With Ulcerative Colitis. [2023]Bowel urgency is commonly experienced by patients with ulcerative colitis (UC) and is associated with reduced health-related quality of life (QoL). Mirikizumab, a humanized monoclonal antibody directed against the p19 subunit of IL-23, significantly reduced bowel urgency in a double-blind, randomized, placebo-controlled Phase 2 clinical trial in patients with moderate-to-severe UC (NCT02589665).
Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes. [2023]To evaluate the effect of mirikizumab, a p19-targeted anti-interleukin-23, on histological and/or endoscopic outcomes in moderately-to-severely active ulcerative colitis [UC].
Mirikizumab: First Approval. [2023]Mirikizumab (Omvoh®), a humanized IgG4 anti-human IL-23p19 monoclonal antibody, is being developed by Eli Lilly and Company Ltd for the treatment of ulcerative colitis and Crohn's disease. Mirikizumab was approved in March 2023 in Japan for use as induction and maintenance therapy in patients with moderate to severe ulcerative colitis who have an inadequate response to conventional therapy or therapies and is the first IL-23p19 inhibitor to be approved for this indication. Mirikizumab was granted a positive opinion in the EU in March 2023 for the treatment of adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment. This article summarizes the milestones in the development of mirikizumab leading to this first approval for use in ulcerative colitis.
Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. [2023]Mirikizumab is a humanized anti-interleukin-23-p19 monoclonal antibody being developed for ulcerative colitis and Crohn's disease. This analysis characterized mirikizumab pharmacokinetics using phase II and III trial data from patients with moderately to severely active ulcerative colitis.
Mirikizumab Improves Quality of Life in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From the Phase 3 LUCENT-1 Induction and LUCENT-2 Maintenance Studies. [2023]Mirikizumab, an anti-IL-23p19 antibody, demonstrated efficacy in phase 3, randomized, double-blind, placebo-controlled LUCENT-1 (induction/NCT03518086) and LUCENT-2 (maintenance/NCT03524092) ulcerative colitis (UC) studies. We evaluated the effect of mirikizumab on quality-of-life (QoL) outcomes in these studies.