Mirikizumab for Pouchitis

Recruiting at 4 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether mirikizumab can reduce symptoms for individuals with pouch disorders, such as chronic pouchitis or Crohn's-like disease of the pouch. Participants will take mirikizumab every four weeks for a year and monitor their symptoms. The trial seeks adults with persistent pouch problems unresponsive to antibiotics or Crohn's-like issues following specific surgeries. Those considering mirikizumab as a treatment option may find this trial suitable. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

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.

What is the safety track record for this treatment?

Research shows that mirikizumab is generally well-tolerated. Previous studies found that individuals using mirikizumab for conditions like ulcerative colitis experienced positive results over time. Specifically, 85.4% of patients who were doing well after one year continued to do well after three years.

Regarding safety, some studies indicate that side effects are uncommon and usually manageable. Although specific side effects for pouch disorders aren't detailed, mirikizumab's presence in a Phase 4 trial indicates it has undergone earlier safety testing and is considered safe enough for wider use.

This information should reassure potential trial participants about the treatment's safety. However, like any medication, some risks may exist, so discussing these with the trial team is always advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Mirikizumab is unique because it targets the protein interleukin-23 (IL-23), which plays a key role in inflammation. Unlike other treatments for pouchitis that often focus on broad-spectrum antibiotics or anti-inflammatory drugs, mirikizumab specifically blocks IL-23, potentially reducing inflammation more effectively. Researchers are excited about this treatment because it offers a more targeted approach, which might lead to better outcomes with fewer side effects compared to traditional therapies.

What evidence suggests that mirikizumab might be an effective treatment for pouch disorders?

Research has shown that mirikizumab effectively treats ulcerative colitis, a condition similar to pouchitis. Studies have found that ongoing treatment with mirikizumab helps most patients remain symptom-free. Among those who initially responded well, 85.4% continued to improve, and 70.1% remained symptom-free after three years. This evidence suggests that mirikizumab, which all participants in this trial will receive, could significantly reduce symptoms and help maintain remission in pouch disorders. ^{1 2 3 4 6}

Who Is on the Research Team?

Edward Barnes, MD, MPH

Principal Investigator

University of North Carolina

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06864403

NCT06864403 | Mirikizumab in the Treatment of Chronic ... 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:.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39448057/

Results From the LUCENT-3 Open-Label Extension Study 3-year continuous treatment with mirikizumab maintained clinical remission in most induction clinical responders, regardless of previous biologic failure ...

3. academic.oup.com academic.oup.com/ibdjournal/article/31/7/1876/7839837

Three-Year Efficacy and Safety of Mirikizumab Following 152 ... For week 52 mirikizumab remitters, 85.4% demonstrated clinical response, and 70.1% demonstrated clinical remission at week 152 (Figure 1).

4. bmcgastroenterol.biomedcentral.com bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-03627-2

Efficacy and safety of Mirikizumab for ulcerative colitis Mirikizumab demonstrates significant efficacy in treating UC, substaintially improving clinical, endoscopic, and histological outcomes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11773515/

Pouchitis unveiled: exploring clinical features, diagnosis, and ... Results showed significant improvement in disease activity with both treatments after the first week (p < 0.01), though improvements moderated ...

6. gastrojournal.org gastrojournal.org/article/S0016-5085(21)03725-2/fulltext

Efficacy and Safety of Mirikizumab in a Randomized Phase ... The 12-week endoscopic outcomes were consistently dose related with the greatest improvements in the 1000 mg mirikizumab group. PRO and CDAI ...