Mirikizumab for Inflammatory Bowel Disease

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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

I have been diagnosed with moderate-to-severe Crohn's Disease or Ulcerative Colitis.
I can understand and agree to the study's requirements.
I am 60 years old or older.

Exclusion Criteria

I haven't had cancer in the last 5 years, except for certain skin cancers that were fully removed.
I do not have serious heart problems or uncontrolled high blood pressure.
Current use or recent participation (within 30 days) in another clinical trial involving investigational therapies
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mirikizumab according to FDA-approved guidelines for 24 weeks

24 weeks
Visits at baseline (Week 0), Week 12, and Week 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks
Visit at Week 48

What Are the Treatments Tested in This Trial?

Interventions

  • Mirikizumab
Trial Overview The trial tests the safety and effectiveness of Mirikizumab in older adults with inflammatory bowel diseases. It aims to see if patients can achieve and maintain clinical remission after treatment, control symptoms without steroids, reduce inflammation markers, and improve overall well-being.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Mirikizumab Treatment GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rubix LS

Lead Sponsor

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39448057/
Results From the LUCENT-3 Open-Label Extension Study3-year continuous treatment with mirikizumab maintained clinical remission in most induction clinical responders, regardless of previous biologic failure ...
Mirikizumab impact on disease clearance in patients with ...The proportions of patients achieving disease clearance with mirikizumab at W12, W52, and W104 were 16.0%, 36.4%, and 51.3%, respectively.
Evaluating the Efficacy and Safety of Mirikizumab in Adults ...This research study looks at how safe and effective a medicine called Mirikizumab is for treating older adults (aged 60 and above) who have moderate to severe ...
Efficacy and safety of mirikizumab in patients with ...Mirikizumab was safe and effective as induction and maintenance treatment for patients with moderately-to-severely active Crohn's disease who ...
S1887 Efficacy and Safety of Mirikizumab in the Treatment...Mirikizumab is effective in achieving clinical and endoscopic remission in IBD, including in biologic-experienced patients. Its favorable safety profile, with ...
Articles Efficacy and safety of mirikizumab in patients with ...Mirikizumab was safe and effective as induction and maintenance treatment for patients with moderately-to-severely active Crohn's disease.
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