Mirikizumab for Ulcerative Colitis

Not currently recruiting at 718 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Cancer, Hepatitis B/C, HIV/AIDS, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called mirikizumab for people with ulcerative colitis (UC), a condition that causes inflammation and sores in the digestive tract. The researchers aim to evaluate the effectiveness and safety of mirikizumab for long-term use over three years. This trial includes those who participated in previous studies with this drug and have not experienced major issues like surgery for UC, serious infections, or new health conditions such as cancer. Participants will receive the treatment through a simple injection. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment for UC.

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 trial coordinators or your doctor.

Is there any evidence suggesting that mirikizumab is likely to be safe for humans?

Research shows that mirikizumab has been tested for safety in people with ulcerative colitis. Studies have found that the most common side effects include cold-like symptoms, soreness at the injection site, joint pain, and skin issues.

Additionally, after three years of continuous treatment with mirikizumab, many patients maintained their health improvements, even if they had tried other similar treatments before. This suggests that the treatment is generally well-tolerated over a long period.

While these side effects might sound concerning, they are usually not severe and can be managed. Such studies help doctors understand a treatment's safety and potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Unlike the standard treatments for ulcerative colitis, which often include corticosteroids or immunosuppressants, mirikizumab offers a fresh approach by specifically targeting the p19 subunit of interleukin-23 (IL-23), a protein involved in inflammation. This targeted mechanism is designed to reduce inflammation more directly and with potentially fewer side effects. Additionally, mirikizumab is administered subcutaneously, which might provide a more convenient option compared to some current therapies that require intravenous administration. Researchers are excited about the potential for this treatment to offer more precise, effective, and manageable relief for patients with ulcerative colitis.

What evidence suggests that mirikizumab might be an effective treatment for ulcerative colitis?

Research shows that mirikizumab, the investigational treatment in this trial, offers promising results for people with ulcerative colitis (UC). Studies have found that mirikizumab can quickly and consistently reduce bowel urgency, a common UC symptom. After one year, 58% of those who improved early showed visible healing in their colon. Additionally, in a long-term study, most individuals who initially responded to treatment remained in remission for three years. These findings suggest that mirikizumab could effectively manage UC symptoms and aid in colon healing. ^{1 2 3 4 6}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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 have not had, nor am I likely to need, surgery for ulcerative colitis during the study.

I do not have significant infections like hepatitis or HIV/AIDS.

I have not developed any new conditions, including cancer, since my original study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mirikizumab subcutaneously for long-term efficacy and safety evaluation

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue to receive mirikizumab until it is available in their country or until they meet discontinuation criteria

Indefinite

What Are the Treatments Tested in This Trial?

Interventions

• Mirikizumab

Trial Overview

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.

How Is the Trial Designed?

Group I: Mirikizumab Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead 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

In a Phase 2 clinical trial involving 249 patients with moderate-to-severe ulcerative colitis, mirikizumab significantly reduced bowel urgency, which is linked to improved quality of life and clinical outcomes.

Patients who experienced no bowel urgency after 12 weeks of treatment showed greater improvements in disease activity and inflammatory markers compared to those who still had urgency, indicating that managing urgency could be a key treatment goal in ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Bowel Urgency on Quality of Life and Clinical Outcomes in Patients With Ulcerative Colitis. Dubinsky, MC., Panaccione, R., Lewis, JD., et al.[2023]

Mirikizumab, an anti-interleukin-23 treatment, significantly improved histological and endoscopic outcomes in patients with moderately-to-severely active ulcerative colitis, showing better results compared to placebo in a study involving 1162 patients at Week 12 and 544 patients at Week 40.

Achieving early endoscopic and histological improvements with mirikizumab was linked to better long-term outcomes, including clinical remission and reduced symptoms, highlighting the importance of early intervention in managing ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes. Magro, F., Pai, RK., Kobayashi, T., et al.[2023]

In two Phase 3 trials involving 1162 patients for induction and 544 for maintenance, mirikizumab significantly improved bowel urgency in ulcerative colitis patients compared to placebo, with higher rates of clinically meaningful improvement and remission at both 12 and 52 weeks.

Patients who experienced improvement in bowel urgency while on mirikizumab also showed better overall clinical outcomes, including higher rates of clinical remission and improved quality of life, indicating that addressing bowel urgency can enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Dubinsky, MC., Clemow, DB., Hunter Gibble, T., et al.[2023]

In a study involving patients with moderate to severe ulcerative colitis who initially did not respond to mirikizumab after 12 weeks, 50% of those receiving an additional 12 weeks of 600 mg mirikizumab achieved a clinical response, indicating that extended treatment can be effective for nonresponders.

Among those who responded to the extended treatment, 65.8% maintained their clinical response for up to 52 weeks, demonstrating the long-term efficacy of mirikizumab without new safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. Sandborn, WJ., Ferrante, M., Bhandari, BR., et al.[2022]

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 phase 3 studies (LUCENT-1 and LUCENT-2) involving 1162 patients with moderately-to-severely active ulcerative colitis, mirikizumab significantly improved quality of life outcomes, including scores on the Inflammatory Bowel Disease Questionnaire and the 36-Item Short Form Health Survey.

Mirikizumab-treated patients showed higher rates of achieving response and remission in quality of life measures compared to placebo, indicating its efficacy in enhancing overall well-being in patients with ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Sands, BE., Feagan, BG., Hunter Gibble, T., et al.[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]

Citations

1.

lilly.gcs-web.com

lilly.gcs-web.com/news-releases/news-release-details/lillys-omvoh-mirikizumab-mrkz-demonstrated-early-and-sustained

Lilly's Omvoh (mirikizumab-mrkz) demonstrated early and ...

Lilly's Omvoh (mirikizumab-mrkz) demonstrated early and sustained improvement in bowel urgency outcomes for patients with ulcerative colitis.

2.

omvoh.lilly.com

omvoh.lilly.com/ulcerative-colitis/clinical-results

UC Clinical Results & Safety Data | Omvoh® (mirikizumab-mrkz)

Omvoh works within your gut to help repair your colon lining at 1 year. Among people that saw improvement at Week 12, 58% had visible healing of their colon ...

3.

prnewswire.com

prnewswire.com/news-releases/lillys-omvoh-mirikizumab-mrkz-demonstrated-early-and-sustained-improvement-in-bowel-urgency-outcomes-for-patients-with-ulcerative-colitis-302594395.html

Lilly's Omvoh (mirikizumab-mrkz) demonstrated early and ...

Lilly's Omvoh (mirikizumab-mrkz) demonstrated early and sustained improvement in bowel urgency outcomes for patients with ulcerative colitis.

4.

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 ...

5.

omvoh.lilly.com

omvoh.lilly.com/hcp/ulcerative-colitis/clinical-studies

Clinical Studies, Trial Design & Data | UC - Omvoh - Eli Lilly

Three-year efficacy and safety of mirikizumab following 152 weeks of continuous treatment for ulcerative colitis: results from the LUCENT-3 open-label extension ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02589665

NCT02589665 | A Study of Mirikizumab (LY3074828) in ...

The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants ...