Mirikizumab for Inflammatory Bowel Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of Mirikizumab for older adults with moderate to severe Crohn's disease or ulcerative colitis, both of which cause painful swelling in the digestive tract. Although Mirikizumab is approved for these conditions, its effectiveness specifically for individuals aged 60 and above remains unclear. The trial aims to determine if it can reduce or eliminate symptoms without causing serious side effects. Participants sought are aged 60 or older with moderate to severe symptoms, who haven't had recent major surgery or active infections. The goal is to improve the quality of life for older adults with these conditions. As a Phase 4 trial, this study focuses on understanding how Mirikizumab, already FDA-approved and proven effective, can benefit more patients and enhance their quality of life.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to understand how your current treatments might interact with the trial.
What is the safety track record for Mirikizumab?
Research has shown that Mirikizumab is generally safe for individuals with conditions like Crohn's disease. Studies have found it both safe and effective for those with moderate to severe Crohn's disease. Reports from previous patients indicate they tolerated Mirikizumab well during treatment.
The FDA has already approved Mirikizumab for inflammatory bowel disease (IBD), which suggests its safety for most people. This study focuses on older adults, who might have different needs or reactions, but the treatment's existing approval indicates it has been well-researched and is considered safe to use.12345Why are researchers enthusiastic about this study treatment?
Mirikizumab is unique because it targets the p19 subunit of interleukin-23 (IL-23), a protein that plays a key role in the inflammation process associated with Crohn's Disease and Ulcerative Colitis. Unlike traditional treatments that often target TNF-alpha, Mirikizumab's mechanism may offer a more precise approach, potentially improving effectiveness and reducing side effects. Researchers are excited about this treatment because it could provide a new option for patients who have not responded well to existing therapies, offering hope for better control of symptoms and improved quality of life.
What is the effectiveness track record for Mirikizumab in treating inflammatory bowel disease in older adults?
Research has shown that Mirikizumab effectively treats inflammatory bowel diseases such as Crohn's disease and ulcerative colitis. In one study, most patients who initially responded to Mirikizumab remained in remission for three years. After two years of treatment, about 51.3% of patients showed no signs of the disease. It is considered safe and effective for individuals with moderate to severe Crohn's disease. Mirikizumab can also help patients achieve remission, even if they have previously tried similar treatments. Overall, it maintains a good safety record for managing these conditions.12346
Are You a Good Fit for This Trial?
This trial is for adults over 60 with moderate to severe Crohn's Disease or Ulcerative Colitis. Participants must be able to receive Mirikizumab according to FDA guidelines. Specific inclusion and exclusion criteria details are not provided, but typically involve health status and absence of conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Mirikizumab according to FDA-approved guidelines for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mirikizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rubix LS
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University