Mirikizumab for Pouchitis

Overseen By Mikki Sandridge

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of North Carolina, Chapel Hill

Must be taking: Antibiotics

Disqualifiers: HIV, Hepatitis B/C, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

25 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It is best to discuss this with the trial organizers or your healthcare provider.

Is Mirikizumab safe for humans?

Mirikizumab has been studied for safety in conditions like ulcerative colitis and Crohn's disease, showing it is generally safe for human use. It has been approved in Japan and received a positive opinion in the EU for treating ulcerative colitis, indicating regulatory confidence in its safety profile. ^{1 2 3 4 5}

What makes the drug Mirikizumab unique for treating pouchitis?

Mirikizumab is unique for treating pouchitis because it targets specific immune pathways involved in inflammation, which may offer a novel approach compared to existing treatments. There are currently no standard treatments specifically approved for pouchitis, making Mirikizumab a potentially innovative option. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to learn if mirikizumab works to treat pouch disorders in adults. The main questions it aims to answer are: Does mirikizumab reduce symptoms of pouch disorders Participants will: Take mirikizumab every 4 weeks for one year Visit the clinic once every month for two months and at the end of the study Keep a diary of their symptoms

Research Team

Edward Barnes, MD, MPH

Principal Investigator

University of North Carolina

Eligibility Criteria

Adults with chronic inflammatory conditions of the pouch, such as Pouchitis or Ileal Pouchitis, are eligible for this trial. Participants must be willing to take mirikizumab injections and visit the clinic regularly for one year while keeping a symptom diary.

Inclusion Criteria

I have been diagnosed with Chronic Pouchitis or Crohn's-like disease of the pouch.

Informed consent will be obtained before any study-related procedures

Ability to access internet for electronic database entry

Exclusion Criteria

Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening

I am currently infected with C. difficile.

Known hypersensitivity to mirikizumab or its metabolites

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take mirikizumab every 4 weeks for one year

52 weeks

Clinic visits once every month for two months and at the end of the study

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mirikizumab

Trial Overview The study is testing whether mirikizumab can reduce symptoms in patients with pouch disorders. It involves receiving either subcutaneous (SC) or intravenous (IV) doses of mirikizumab every four weeks and attending monthly clinic visits.

Participant Groups

Group I: All patients Experimental Treatment 2 Interventions

Open Label Mirikizumab

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

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

Findings from Research

Mirikizumab, an anti-interleukin-23 monoclonal antibody, demonstrated pharmacokinetic properties typical of monoclonal antibodies, with a half-life of approximately 9.5 days and a subcutaneous bioavailability of 48%, based on data from 1362 patients with ulcerative colitis.

The study found that while body weight and serum albumin levels influenced the drug's clearance and distribution, these effects were relatively small compared to individual variability, suggesting that no dose adjustments are necessary based on patient characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. Chua, L., Friedrich, S., Zhang, XC.[2023]

Mirikizumab, an anti-IL-23p19 monoclonal antibody, was approved in March 2023 in Japan for treating moderate to severe ulcerative colitis, marking it as the first IL-23p19 inhibitor approved for this condition.

In the EU, mirikizumab received a positive opinion for adult patients with active ulcerative colitis who did not respond to conventional or biologic therapies, highlighting its potential as a new treatment option for difficult-to-treat cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirikizumab: First Approval. Keam, SJ.[2023]

In a study of 191 patients with moderate-to-severe Crohn's disease, mirikizumab significantly improved endoscopic response at Week 12 compared to placebo, with the highest response rate observed in the 1000 mg group (43.8%).

Mirikizumab demonstrated durable efficacy, maintaining a high endoscopic response rate of around 58.5% at Week 52, while the safety profile was comparable to placebo, indicating it is a promising treatment option for Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn's Disease. Sands, BE., Peyrin-Biroulet, L., Kierkus, J., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Mirikizumab: First Approval. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn's Disease. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of Vedolizumab for Refractory Pouchitis of the Ileo-anal Pouch: Results From a Multicenter US Cohort. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Changes in health-related quality of life and associations with improvements in clinical efficacy: a Phase 2 study of mirikizumab in patients with ulcerative colitis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Rituximab inhibits the in vivo primary and secondary antibody response to a neoantigen, bacteriophage phiX174. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The effects of rituximab on serum IgE and BAFF. [2021]

8. Italy pubmed.ncbi.nlm.nih.gov

[Monoclonal antibodies in nephrology: a delicate balance between curative potential, evidence of effectiveness, and toxicity]. [2015]

9. Germany pubmed.ncbi.nlm.nih.gov

Indications for use and safety of rituximab in childhood renal diseases. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Maintenence rituximab following induction in autoimmune cytopenias. [2023]